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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, publication/study report which meets basic scientific principles, but details missing
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 276-328 g
Route:
intradermal and epicutaneous
Vehicle:
other: ethanol
Concentration / amount:
1 % test substance in ethanol for all administrations
Route:
other: epicutaneous, no more data
Vehicle:
other: ethanol
Concentration / amount:
1 % test substance in ethanol for all administrations
No. of animals per dose:
10 test substance group animals, 5 control animals
Details on study design:
applied volumes: 0.1 mL (intradermal), 0.5 mL (dermal)
Positive control substance(s):
not specified
Reading:
other: first and second readings
Hours after challenge:
48
Group:
test chemical
Dose level:
0.005 mL test substance
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: other: first and second readings. . Hours after challenge: 48.0. Group: test group. Dose level: 0.005 mL test substance. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
other: first and second readings
Hours after challenge:
48
Group:
negative control
Dose level:
0.005 mL test substance
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: first and second readings. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.005 mL test substance. No with. + reactions: 0.0. Total no. in groups: 5.0.

See Attachment for results.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DMM has a strong skin sensitising potential according to the GPMT (1%, all animals positive response).
Executive summary:

The test substance was administered to a group of 10 female guinea pigs intradermally and epicutaneously, according to the scheme given in OECD 406 and the protocol of Magnusson and Kligman. A group of 5 guinea pigs served as negative controls.

48 and 72 hours after the start of the challenge exposure all animals of the test substance group showed very slight to severe erythema including slight eschar formation and very slight to severe edema. No adverse skin reactions were noted in the negative control group.

The results demonstrated that the test substance has a skin-sensitising potential.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Justification for selection of skin sensitisation endpoint:
The only available study, a key study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A clear sensitizing effect was observed when dimethyl maleate was applied repeatedly to skin.

The substance is a strong sensitizer according to CLP and the Guidance on Application of the the CLP-Criteria, section 3.4.2.3.4.3.