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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (ref. XXIV/1377/96, rev.
1/98)
Ingredient : 3-(4'-methylbenzylidene)-d,l camphor
CAS n° : 38102-62-4
Function and maximum use concentration : UV filter, 4 %
Assessment of acute toxicity (oral, intra-peritoneal, dermal) : very low by all routes
Assessment of irritation & corrosivity : no evidence of any adverse effects.
Assessment of capacity to cause sensitisation : negative.
Assessment of capacity to cause photo-toxicity, photo-sensitisation and photo-contact allergy : negative
Assessment of sub-acute and sub-chronic toxicity : relatively high toxicity because of some changes in levels of thyroid hormones; no other serious toxic effects noted.
Assessment of capacity to produce mutagenesis, photo-mutagenesis, clastogenicity and photo-clastogenicity carried out in appropriate bacterial and tissue culture systems was negative.
Tests for embryo-toxicity and teratogenicity were negative.
Tests for Percutaneous absorption in man using radioactive compound suggested a low absorption rate.
A carefully designed double blind study in human volunteers, carried out to a good protocol and under realistic use conditions, showed no adverse effect.
Taking the above findings into consideration, it was concluded that at a maximum use concentration of 4 % the compound was classified 1.
Classification: 1 (See "Classification of Substances")
Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
Ingredient : 3-(4'-methylbenzylidene)-d,l camphor
CAS n° : 38102-62-4
Function and maximum use concentration : UV filter, 4 %
Assessment of acute toxicity (oral, intra-peritoneal, dermal) : very low by all routes
Assessment of irritation & corrosivity : no evidence of any adverse effects.
Assessment of capacity to cause sensitisation : negative.
Assessment of capacity to cause photo-toxicity, photo-sensitisation and photo-contact allergy : negative
Assessment of sub-acute and sub-chronic toxicity : relatively high toxicity because of some changes in levels of thyroid hormones; no other serious toxic effects noted.
Assessment of capacity to produce mutagenesis, photo-mutagenesis, clastogenicity and photo-clastogenicity carried out in appropriate bacterial and tissue culture systems was negative.
Tests for embryo-toxicity and teratogenicity were negative.
Tests for Percutaneous absorption in man using radioactive compound suggested a low absorption rate.
A carefully designed double blind study in human volunteers, carried out to a good protocol and under realistic use conditions, showed no adverse effect.
Taking the above findings into consideration, it was concluded that at a maximum use concentration of 4 % the compound was classified 1.
Classification: 1 (See "Classification of Substances")
Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
