Registration Dossier
Registration Dossier
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EC number: 201-185-2 | CAS number: 79-20-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in human
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Report on human maximization studies. Report to RIFM.
- Author:
- Kligman, AM
- Year:
- 1 976
- Bibliographic source:
- Report to RIFM. (www.rifm.org)
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs: Methyl acetate
- Author:
- Opdyke, DLJ
- Year:
- 1 979
- Bibliographic source:
- Food Cosmet. Toxicol. 17, 859-861.
Materials and methods
- Principles of method if other than guideline:
- 10% methylacetat induction and challenge
- GLP compliance:
- not specified
- Type of study:
- other: maximization test
- Justification for non-LLNA method:
- Study performed in 1979, LLNA method was not available.
Test material
- Reference substance name:
- Methyl acetate
- EC Number:
- 201-185-2
- EC Name:
- Methyl acetate
- Cas Number:
- 79-20-9
- Molecular formula:
- C3H6O2
- IUPAC Name:
- methyl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- other: human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- In a human maximization study, 25 healthy, male (11) and (14) female subjects aged 18-31 years old were used. Test material was applied under occlusion to the same site on the volar forearm ot back of all subjects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate (SLS) under occlusion. Prior to challenge, 5 to 10% SLS was applied to test site for one hour before application of test material. Challenge site was read on patch removal and 24 hours thereafter.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- no sensitisation observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Remarks:
- There is no negative control group as it is a maximisation test with 25 volunteers.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- There is no positive control group as it is a maximisation test with 25 volunteers.
Any other information on results incl. tables
The study result meets the long experience from human exposure to humans. The test method of a maximization test is justified in this case.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The study result meets the long experience from human exposure to humans. The test method of a maximization test is justified in this case.
In this human maximization study no skin sensitisation was observed.
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