Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
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.
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.
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.

The study result meets the long experience from human exposure to humans. The test method of a maximization test is justified in this case.

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.
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
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.
Species:
other: human volunteers
Reading:
other: not applicable as summary of several individuel studies
Group:
test chemical
Dose level:
not applicable as summary of several individuel 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 individuel studies
Remarks:
Reading: other: not applicable as summary of several individuel studies. Group: other: not applicable as summary of several individuel studies. Dose level: not applicable as summary of several individuel studies. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: No senstisation observed in studies. No sensitizing properties from experience.
Reading:
other: long experience with human exposure to the substance
Group:
negative control
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
Reading:
other: long experience with human exposure to the substance
Group:
positive control
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a maximisation test with 25 volunteers no sensitisation was observed after exposure to 10% methyl acetate in petrolatum (Kligman, 1976). 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).

From the overall data base and the long term experience with both methyl acetate and its hydrolysis products methanol and acetic acid it is concluded that methyl acetate has no sensitisation potential. The EU-RAR came to the same conclusion.

Literature

Kligman AM (1976). Report to RIFM (18.05.1976). Cited in: Opdyke (1979), Food Cosmet. Toxicol. 17, 859-861.

Fisher AA (1986). Contact Dermatitis. 3rd edition. Lea & Febiger, Philadelphia 1986, p. 853 and 886.

Weil AJ, Rogers HE (1951). Allergenic reactivity to simple aliphatic acids in man. J. Invest. Dermatol. 17, 227-231.


Migrated from Short description of key information:
Methyl acetate does not cause skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

From experience methyl acetate is not sensitising via the respiratory route. Studies on this endpoint are not available.

Justification for classification or non-classification

Methyl acetate is considered as non sensitising and does not trigger respective classification.