1070 and we have therefore looked at the incidence of acute leukaemia in children less than 15 years old at diagnosis from 1971 to 1977, the period over which the Manchester increase has occurred. The rates (per million children per year) in the Northern Region were:
gion,
’71 43
A
regression
’72 31
’73 37
line drawn
’74 29
through
’75 32
’76 44
these
figures
’77 37
shows
no
sig-
nificant change from the mean. We have therefore not been able to demonstrate an increasing incidence as was found in Lancashire and in the North Western Region. The Northern Region includes Cumbria, but only 11% of the child population of the whole region live in that area. If an environmental influence is responsible for the increasing incidence the factors responsible seem not to be operating in the Northern Region, the population of which is almost entirely east of the Pennines. Children’s Department, Royal Victoria Infirmary Newcastle upon Tyne NE 1 4LP
A. W. CRAFT J. KERNAHAN
LEAD IN HAIR-DYE PREPARATIONS
SIR,-Several hair-dye preparations lead
acetate
in concentrations up
to
on
the market contain
3%. Unlike the organic
phenylenediamine dyes, lead-based dyes gradually darken the hair through the slow formation of lead sulphide, resulting from interaction with hair or atmospheric sulphurous materials.The potential danger of lead-based hair dyes is illustrated by the case described by Dr Waldron in the accompanying letter. This girl has a blood lead concentration of more than 100 fl-g/dl (4.8 mol/1). The upper level of normality laid down by the European Economic Community is 35g/dl (1.7 p.mol/1). When the E.E.C. legislated on cosmetic products,3 it prohibited the use in cosmetics of lead and all its compounds except lead acetate. Lead acetate, for use in hair treatment products only, was placed in annex v ("List of substances excluded from the scope of the Directive"). Member countries of the E.E.C. were required to introduce their own legislation to bring the directive into effect, and the U.K.’s Cosmetic Products Regulations 1978, with some exceptions, came into effect in October, 1978.4 Lead and its compounds, except lead acetate, are also prohibited in the U.K. regulations, but lead acetate and other E.E.C. annex v materials are included in schedule 2, part III ("Restricted substances"). It is specified that lead acetate is only to be used in hair care products, to a maximum concentration of 3%, and with the required information "Wash hands after use. Do not use on broken or abraded skin. Keep out of reach of children". The provisions regarding labelling came into effect on July 29, 1979 (for products made before then and sold by retail the date is July 29, 1981). An interesting difference between the E.E.C. and U.K. legislation is that the U.K. requires that "a cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use"; the preamble to the E.E.C. directive states "cosmetic products must not be harmful under normal or foreseeable conditions of use" (our italics). We are convinced that if a product containing lead acetate is to be on free sale (and we have grave doubts of the wisdom JF. Hair dyes. In: Venkataraman K, ed. The chemistry of synthetic dyes. New York: Academic Press, 1971; 475-534. 2. European Economic Community. Council directive on biological screening of the population for lead. Offic J Europ Commun 1977; 20: no L105/10-17. 3. European Economic Community. Council directive on the approximation of the laws of the member states relating to cosmetic products. Offic J Europ Commun 1976; 19: no L262/169-200. 4. The Cosmetic Products Regulations 1978; statutory instrument no 1354, London H.M. Stationery Office: 45. 1. Corbett
of this), it must carry effective information concerning its toxicity and dangers to children. We also believe that it should be clearly identified as containing a lead compound, both to warn the user and to inform any doctor who might be consulted in a case of suspected poisoning. Such information should be on the container itself, not just on the outer packing or instructions which may be discarded soon after purchase. An old name for lead acetate is "sugar of lead". It has a sweet, not unpleasant taste, and a child who once tastes it may well be tempted to repeat the experience. When the British regulations were in draft form they were circulated by the Departments of Industry, Trade, and Prices and Consumer Protection for comment. We then expressed our serious concern over a number of safety matters, including the labelling of lead-based hair dyes. We were informed that, because lead acetate was excluded from the scope of the E:E.C. directive, the U.K. Government had no power to require the naming of lead on the label. However, the present regulations were made under the Consumer Protection Act 1961. We were also informed that the Government intended to remake the regulations under the new Consumer Safety Act 1978, and, when this was done, the "possible need for this ingredient to be named on the label of such products" would be borne in mind. In the proposal for a Council directive on cosmetic products, on which the 1976 E.E.C. Directive was based, lead acetate was included in annex iv, part 1 ("List of substances provisionally allowed"). The maximum concentration authorised was then to be 1-75% calculated as lead, equivalent to 2.8% lead acetate trihydrate, and the label was to carry "Contains lead acetate". Why was this requirement omitted from the final version? In December last year a House of Commons committee discussing the Cosmetic Products Regulations 1978 was told by Mr John Fraser (then Minister of State, Department of Prices and Consumer Protection): "We now have power under the Consumer Safety Act to require specific labelling. That is a power we did not possess before:"5 We suggest that the labelling of lead-cotaining hair dyes is now a matter of urgency, and that action should not be delayed until the current regulations are amended, which will inevitably be a slow process. Meanwhile, as the incident in Birmingham shows, family and hospital doctors should be aware that one cause of unexplained symptoms in a child could be ingestion of widely available hair dyes containing lead. Department of Cancer Studies, Medical School,
University of Birmingham, Birmingham B15 2TJ
C.E.SEARLE D. G. HARNDEN
LEAD POISONING FROM COSMETICS
SIR,-While investigating the distribution of blood lead concentrations among young children in Birmingham we have encountered a case of lead poisoning which was almost certainly due to the ingestion of lead from a cosmetic preparation. The patient was a 4-year-old girl of West Indian parents. Her blood lead was 136 g/dl (6-6mol/1), and her erythrocyte protoporphyrin concentration was 512 g/dl. When remeasured, these values were 95 g/dl (4’6 mol/1) and 508 g/d!, respectively. The child’s home was examined by the environmental health department, and the only obvious source of lead was a bottle of Morgan’s perfumed pomade which the mother used to darken her hair. When directly questioned, the mother admitted that her child was in the habit of putting her fingers into cosmetics and licking them. The label on the bottle of pomade states that it contains "Plumb. acet. 3%" and that the hands should be washed after use, but it does not specifically mention the need to keep the product away from children. 5. Third
Standing Committee on Statutory Instruments, etc. Hansard (House of Commons) Dec. 13, 1978. London: H.M. Stationery Office.
1071
preparations on the market contain ranging from 0.26 to 3-13% (Morgans’ perfumed pomade 3-13%, Morgan’s pomade 2-71%, ’Formula 16’ 0.26%, ’Restoria’ cream 0.37%, ’NoMoR Grey’ 0-75%, ’Grecian 2000’ 0.82%). Only the Morgan’s pomades state on the label (albeit obliquely) that the product contains lead acetate. All the products carry some warnings, on the label or in the instruction leaflet, to the effect that the hands must be washed after use, that the product should not be used if the skin is broken or abraded, and that it should be kept Other hair-darkening lead acetate in amounts
away from children.
The concentration of lead in hair care products must not exceed 3% (Cosmetic Products Regulations 1978; SI 1978 no. 1354). The regulations also require that the following instructions are given: wash hands after use; do not use on broken or abraded skin; keep out of reach of children. There is no requirement to state that the products contain lead. Moreover, these regulations do not have effect for retail sale until after
July 29,1981. It seems clear, however, that these products may pose a serious threat of lead poisoning in young children and that the manufacturers should be obliged to state this unequivocally on the label. To bury a warning on the instruction leaflet inside the pack is not sufficient. Most parents have been made aware of the need to keep medicines out of reach of their children; they should also be made aware of the need to take similar precautions with cosmetics. I thank Mr A. Archer and his staff at the City of Birmingham environmental health department for their help and Mr A. H. Coombes for the chemical analyses of hair care products. This work is part of the survey being undertaken under the auspices of the Steering Committee on Environmental Lead. London School of Hygiene and Tropical Medicine, London WC1E 7HT
H. A. WALDRON
NALOXONE: NON-STEROIDAL TREATMENT FOR POSTMENOPAUSAL FLUSHING?
SIR,-Although about 85% of women experience attacks of flushing and sweating at some time’ the cause of this vasomotor instability is poorly understood.2 Treatment with cestrogen provides the only satisfactory remedy. Infusion of an enkephalin analogue causes severe facial flushing,3 and naloxone, a pure opiate antagonist, inhibits the chlorpropramideinduced alcoholic flushing of diabetics and the flushing caused by infusion of the enkephalin analogue.’ We have investigated the effect of infusion of naloxone on postmenopausal flushing. who had had severe and frequent postmenopausal for between 10 months and 25 years all gave informed consent to the study. They were admitted to a metabolic ward on the day before the start of investigations. On the following day, a 19 g cannula was inserted into an antecubital vein. A record of flushes was kept by the nurses, who were called to each flushing episode. On the next morning an infusion pump was set up and naloxone or saline was infused and a flush chart was kept as on the previous day. The day was divided into eight periods of 90 min. Four of these periods were allocated to infusions of naloxone (22.2 ug,/min) and four to infusions of the same volume of physiological saline. The order of these eight infusions had been randomised before the study and the contents of the syringes used for the infusions were unknown to the patient, the nurses, or the doctor overseeing the infusions. The contents of the syringes (40 ml) were infused at a rate of 26-7 7 ml/h so each infusion took 90 min. Four
women
flushing
1. Sanes KI. Hot flushes systems as factors
of menopause The vegetative, nervous, and endocrine or
menopause disturbance. Trans Am Assoc Obstet
Gynecol 1920; 32: 182-210. 2. Mulley G, Mitchell JRA. Menopausal flushing: Does œstrogen therapy make sense? Lancet 1976; i: 1397-99. 3. Stubbs WA, Jones A, Edwards CRW, Delitala G, Jeffcoate WJ, Ratter SJ, Besser GM, Bloom SR, Alberti KGMM. Hormonal and metabolic responses to an enkephalin analogue in normal man. Lancet 1978; ii: 1225-27. 4. Leslie
RDG, Pyke DA, Stubbs WA. Sensitivity to enkephalin non-insulin dependent diabetes. Lancet 1979; i: 341-43.
as a cause
of
DAY1
Flushing day (day 2).
attacks
Time ofdoy
(vertical bars)
on
control
DAY2
day (day 1)
and
study
The flushing attacks are shown in the figure. The four patients had 34 flushing episodes on the control day between 10 A.M. and 10 P.M. and 21 episodes between the same times during the treatment day. However, on the treatment day there were 16 flushes during the four 90 min placebo periods but only 5 during the naloxone periods. (p
gion,
’71 43
A
regression
’72 31
’73 37
line drawn
’74 29
through
’75 32
’76 44
these
figures
’77 37
shows
no
sig-
nificant change from the mean. We have therefore not been able to demonstrate an increasing incidence as was found in Lancashire and in the North Western Region. The Northern Region includes Cumbria, but only 11% of the child population of the whole region live in that area. If an environmental influence is responsible for the increasing incidence the factors responsible seem not to be operating in the Northern Region, the population of which is almost entirely east of the Pennines. Children’s Department, Royal Victoria Infirmary Newcastle upon Tyne NE 1 4LP
A. W. CRAFT J. KERNAHAN
LEAD IN HAIR-DYE PREPARATIONS
SIR,-Several hair-dye preparations lead
acetate
in concentrations up
to
on
the market contain
3%. Unlike the organic
phenylenediamine dyes, lead-based dyes gradually darken the hair through the slow formation of lead sulphide, resulting from interaction with hair or atmospheric sulphurous materials.The potential danger of lead-based hair dyes is illustrated by the case described by Dr Waldron in the accompanying letter. This girl has a blood lead concentration of more than 100 fl-g/dl (4.8 mol/1). The upper level of normality laid down by the European Economic Community is 35g/dl (1.7 p.mol/1). When the E.E.C. legislated on cosmetic products,3 it prohibited the use in cosmetics of lead and all its compounds except lead acetate. Lead acetate, for use in hair treatment products only, was placed in annex v ("List of substances excluded from the scope of the Directive"). Member countries of the E.E.C. were required to introduce their own legislation to bring the directive into effect, and the U.K.’s Cosmetic Products Regulations 1978, with some exceptions, came into effect in October, 1978.4 Lead and its compounds, except lead acetate, are also prohibited in the U.K. regulations, but lead acetate and other E.E.C. annex v materials are included in schedule 2, part III ("Restricted substances"). It is specified that lead acetate is only to be used in hair care products, to a maximum concentration of 3%, and with the required information "Wash hands after use. Do not use on broken or abraded skin. Keep out of reach of children". The provisions regarding labelling came into effect on July 29, 1979 (for products made before then and sold by retail the date is July 29, 1981). An interesting difference between the E.E.C. and U.K. legislation is that the U.K. requires that "a cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use"; the preamble to the E.E.C. directive states "cosmetic products must not be harmful under normal or foreseeable conditions of use" (our italics). We are convinced that if a product containing lead acetate is to be on free sale (and we have grave doubts of the wisdom JF. Hair dyes. In: Venkataraman K, ed. The chemistry of synthetic dyes. New York: Academic Press, 1971; 475-534. 2. European Economic Community. Council directive on biological screening of the population for lead. Offic J Europ Commun 1977; 20: no L105/10-17. 3. European Economic Community. Council directive on the approximation of the laws of the member states relating to cosmetic products. Offic J Europ Commun 1976; 19: no L262/169-200. 4. The Cosmetic Products Regulations 1978; statutory instrument no 1354, London H.M. Stationery Office: 45. 1. Corbett
of this), it must carry effective information concerning its toxicity and dangers to children. We also believe that it should be clearly identified as containing a lead compound, both to warn the user and to inform any doctor who might be consulted in a case of suspected poisoning. Such information should be on the container itself, not just on the outer packing or instructions which may be discarded soon after purchase. An old name for lead acetate is "sugar of lead". It has a sweet, not unpleasant taste, and a child who once tastes it may well be tempted to repeat the experience. When the British regulations were in draft form they were circulated by the Departments of Industry, Trade, and Prices and Consumer Protection for comment. We then expressed our serious concern over a number of safety matters, including the labelling of lead-based hair dyes. We were informed that, because lead acetate was excluded from the scope of the E:E.C. directive, the U.K. Government had no power to require the naming of lead on the label. However, the present regulations were made under the Consumer Protection Act 1961. We were also informed that the Government intended to remake the regulations under the new Consumer Safety Act 1978, and, when this was done, the "possible need for this ingredient to be named on the label of such products" would be borne in mind. In the proposal for a Council directive on cosmetic products, on which the 1976 E.E.C. Directive was based, lead acetate was included in annex iv, part 1 ("List of substances provisionally allowed"). The maximum concentration authorised was then to be 1-75% calculated as lead, equivalent to 2.8% lead acetate trihydrate, and the label was to carry "Contains lead acetate". Why was this requirement omitted from the final version? In December last year a House of Commons committee discussing the Cosmetic Products Regulations 1978 was told by Mr John Fraser (then Minister of State, Department of Prices and Consumer Protection): "We now have power under the Consumer Safety Act to require specific labelling. That is a power we did not possess before:"5 We suggest that the labelling of lead-cotaining hair dyes is now a matter of urgency, and that action should not be delayed until the current regulations are amended, which will inevitably be a slow process. Meanwhile, as the incident in Birmingham shows, family and hospital doctors should be aware that one cause of unexplained symptoms in a child could be ingestion of widely available hair dyes containing lead. Department of Cancer Studies, Medical School,
University of Birmingham, Birmingham B15 2TJ
C.E.SEARLE D. G. HARNDEN
LEAD POISONING FROM COSMETICS
SIR,-While investigating the distribution of blood lead concentrations among young children in Birmingham we have encountered a case of lead poisoning which was almost certainly due to the ingestion of lead from a cosmetic preparation. The patient was a 4-year-old girl of West Indian parents. Her blood lead was 136 g/dl (6-6mol/1), and her erythrocyte protoporphyrin concentration was 512 g/dl. When remeasured, these values were 95 g/dl (4’6 mol/1) and 508 g/d!, respectively. The child’s home was examined by the environmental health department, and the only obvious source of lead was a bottle of Morgan’s perfumed pomade which the mother used to darken her hair. When directly questioned, the mother admitted that her child was in the habit of putting her fingers into cosmetics and licking them. The label on the bottle of pomade states that it contains "Plumb. acet. 3%" and that the hands should be washed after use, but it does not specifically mention the need to keep the product away from children. 5. Third
Standing Committee on Statutory Instruments, etc. Hansard (House of Commons) Dec. 13, 1978. London: H.M. Stationery Office.
1071
preparations on the market contain ranging from 0.26 to 3-13% (Morgans’ perfumed pomade 3-13%, Morgan’s pomade 2-71%, ’Formula 16’ 0.26%, ’Restoria’ cream 0.37%, ’NoMoR Grey’ 0-75%, ’Grecian 2000’ 0.82%). Only the Morgan’s pomades state on the label (albeit obliquely) that the product contains lead acetate. All the products carry some warnings, on the label or in the instruction leaflet, to the effect that the hands must be washed after use, that the product should not be used if the skin is broken or abraded, and that it should be kept Other hair-darkening lead acetate in amounts
away from children.
The concentration of lead in hair care products must not exceed 3% (Cosmetic Products Regulations 1978; SI 1978 no. 1354). The regulations also require that the following instructions are given: wash hands after use; do not use on broken or abraded skin; keep out of reach of children. There is no requirement to state that the products contain lead. Moreover, these regulations do not have effect for retail sale until after
July 29,1981. It seems clear, however, that these products may pose a serious threat of lead poisoning in young children and that the manufacturers should be obliged to state this unequivocally on the label. To bury a warning on the instruction leaflet inside the pack is not sufficient. Most parents have been made aware of the need to keep medicines out of reach of their children; they should also be made aware of the need to take similar precautions with cosmetics. I thank Mr A. Archer and his staff at the City of Birmingham environmental health department for their help and Mr A. H. Coombes for the chemical analyses of hair care products. This work is part of the survey being undertaken under the auspices of the Steering Committee on Environmental Lead. London School of Hygiene and Tropical Medicine, London WC1E 7HT
H. A. WALDRON
NALOXONE: NON-STEROIDAL TREATMENT FOR POSTMENOPAUSAL FLUSHING?
SIR,-Although about 85% of women experience attacks of flushing and sweating at some time’ the cause of this vasomotor instability is poorly understood.2 Treatment with cestrogen provides the only satisfactory remedy. Infusion of an enkephalin analogue causes severe facial flushing,3 and naloxone, a pure opiate antagonist, inhibits the chlorpropramideinduced alcoholic flushing of diabetics and the flushing caused by infusion of the enkephalin analogue.’ We have investigated the effect of infusion of naloxone on postmenopausal flushing. who had had severe and frequent postmenopausal for between 10 months and 25 years all gave informed consent to the study. They were admitted to a metabolic ward on the day before the start of investigations. On the following day, a 19 g cannula was inserted into an antecubital vein. A record of flushes was kept by the nurses, who were called to each flushing episode. On the next morning an infusion pump was set up and naloxone or saline was infused and a flush chart was kept as on the previous day. The day was divided into eight periods of 90 min. Four of these periods were allocated to infusions of naloxone (22.2 ug,/min) and four to infusions of the same volume of physiological saline. The order of these eight infusions had been randomised before the study and the contents of the syringes used for the infusions were unknown to the patient, the nurses, or the doctor overseeing the infusions. The contents of the syringes (40 ml) were infused at a rate of 26-7 7 ml/h so each infusion took 90 min. Four
women
flushing
1. Sanes KI. Hot flushes systems as factors
of menopause The vegetative, nervous, and endocrine or
menopause disturbance. Trans Am Assoc Obstet
Gynecol 1920; 32: 182-210. 2. Mulley G, Mitchell JRA. Menopausal flushing: Does œstrogen therapy make sense? Lancet 1976; i: 1397-99. 3. Stubbs WA, Jones A, Edwards CRW, Delitala G, Jeffcoate WJ, Ratter SJ, Besser GM, Bloom SR, Alberti KGMM. Hormonal and metabolic responses to an enkephalin analogue in normal man. Lancet 1978; ii: 1225-27. 4. Leslie
RDG, Pyke DA, Stubbs WA. Sensitivity to enkephalin non-insulin dependent diabetes. Lancet 1979; i: 341-43.
as a cause
of
DAY1
Flushing day (day 2).
attacks
Time ofdoy
(vertical bars)
on
control
DAY2
day (day 1)
and
study
The flushing attacks are shown in the figure. The four patients had 34 flushing episodes on the control day between 10 A.M. and 10 P.M. and 21 episodes between the same times during the treatment day. However, on the treatment day there were 16 flushes during the four 90 min placebo periods but only 5 during the naloxone periods. (p
