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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
1976
Bibliographic source:
Report to RIFM. (www.rifm.org)
Reference Type:
publication
Title:
Fragrance raw materials monographs: Methyl acetate
Author:
Opdyke, DLJ
Year:
1979
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

Constituent 1
Chemical structure
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

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.