Registration Dossier
Registration Dossier
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EC number: 203-299-8 | CAS number: 105-45-3
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature; result presented without detailed documentation.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Report to RIFM, 10 May 1976
- Author:
- Kligman AM
- Year:
- 1 976
- Bibliographic source:
- Cited in Opdyke DLJ (1978). Fragrance raw materials monographs. Methyl acetoacetate. Food Cosmet Toxicol 16: 815
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- The maximization test was carried out according to Kligman AM and Epstein W (1975). Updating the maximization test for identifying contact allergens. Contact Dermatitis 1: 231. Cited in Opdyke DLJ (1978). Fragrance raw materials monographs. Methyl acetoacetate. Food Cosmet Toxicol 16: 815, and Kligman AM (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. J Invest Derm 47: 393. Cited in Opdyke DLJ (1978). Fragrance raw materials monographs. Methyl acetoacetate. Food Cosmet Toxicol 16: 815.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl acetoacetate
- EC Number:
- 203-299-8
- EC Name:
- Methyl acetoacetate
- Cas Number:
- 105-45-3
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 3-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl acetoacetate, RIFM no. 76-192
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- no further data - Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: maximization test
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: no data
- Vehicle / solvent: petrolatum
- Concentrations: 8 %
- Volume applied: no data
- Testing/scoring schedule: no data
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system: no data
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- The maximization test performed with 25 volunteers produced no sensitization reactions.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
