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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
review of literature and assessment of available human, animal and alternative data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
EU Risk Asseessment Report Methyl Acetate
Author:
European Commission - ECB
Year:
2003
Bibliographic source:
Office for Official Publications of the European Communities, Luxemburg

Materials and methods

Principles of method if other than guideline:
review of literature and assessment of available human, animal and alternative data
GLP compliance:
not specified
Type of study:
other: review of literature and assessment of available human, animal and alternative data
Justification for non-LLNA method:
Study performed in 2003; when LLNA has not been an accepted OECD test method.

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 volunteers

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Not applicable as summary of several individual studies
Hours after challenge:
0
Group:
test chemical
Dose level:
Not applicable as summary of several individual studies
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No senstisation observed in studies. No sensitizing properties from experience
Remarks on result:
other: Summary of several individual studies
Key result
Reading:
other: long experience with human exposure to the substance
Hours after challenge:
0
Group:
negative control
Dose level:
No negative control tested
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not measured/tested
Remarks on result:
not measured/tested
Remarks:
No negative control exists due to a maximisation test with 25 volunteers long experience with human exposure to the substance
Key result
Reading:
other: long experience with human exposure to the substance
Hours after challenge:
0
Group:
positive control
Dose level:
No positive control tested
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not measured/tested
Remarks on result:
not measured/tested
Remarks:
No positive control exists due to a maximisation test with 25 volunteers and a long experience with human exposure to the substance.

Any other information on results incl. tables

"Total no. in group" refers to study by Kligman, only. This study is citied in EU-RAR, 2003.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Taking into account the long experience with human exposure to the substance, and the absence of any reports on contact allergy in exposed persons, methyl acetate is not expected to exhibit skin sensitizing properties, especially since the substance is hydrolysed in contact with water by non-specific tissue esterases to methanol and acetic acid. For these substances a skin sensitisation potential is either absent (methanol, Fisher, 1986) or restricted to a few cases (acetic acid, Weil and Rogers, 1951).
Executive summary:

The result meets the long experience from human exposure to humans.