Summary sheet on Commission
Review (ref. XXIV/1430/96)
Ingredient: 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)
CAS n° : 145-39-1
Function: Fragrance ingredient
Max in use concentration: not applicable
Assessment of acute toxicity (dermal, oral, i.v., i.p.)
- oral: apparently low. Repeated dose (3): full report not available
- dermal: apparently low; full report not available
Assessment of irritation & corrosivity:
- slight irritation (mucous membranes)
- no significant local effects (skin)
- not photo-irritant
Assessment of chronic/sub-chronic toxicity:
- Repeated dose toxicity (90d)
- dermal application: within a reasonable NOAEL
- oral: no data available
Assessment of reproductive toxicity:
- no data available
Assessment of genotoxicity/carcinogenicity:
- no evidence of mutagenic potential in the Salmonella test; weakly positive in chromosome aberration assay (CHO cells)
Assessment on allergenicity/sensitisation:
- no sensitisation; no photo-allergenicity (pre-clinical)
- weak human photo-allergen
Percutaneous absorption:
- In vitro : high absorption rate (rat),
- low to moderate (pig)
Classification : 2a (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: 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)
CAS n° : 145-39-1
Function: Fragrance ingredient
Max in use concentration: not applicable
Assessment of acute toxicity (dermal, oral, i.v., i.p.)
- oral: apparently low. Repeated dose (3): full report not available
- dermal: apparently low; full report not available
Assessment of irritation & corrosivity:
- slight irritation (mucous membranes)
- no significant local effects (skin)
- not photo-irritant
Assessment of chronic/sub-chronic toxicity:
- Repeated dose toxicity (90d)
- dermal application: within a reasonable NOAEL
- oral: no data available
Assessment of reproductive toxicity:
- no data available
Assessment of genotoxicity/carcinogenicity:
- no evidence of mutagenic potential in the Salmonella test; weakly positive in chromosome aberration assay (CHO cells)
Assessment on allergenicity/sensitisation:
- no sensitisation; no photo-allergenicity (pre-clinical)
- weak human photo-allergen
Percutaneous absorption:
- In vitro : high absorption rate (rat),
- low to moderate (pig)
Classification : 2a (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.