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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl maleate
EC Number:
210-848-5
EC Name:
Dimethyl maleate
Cas Number:
624-48-6
Molecular formula:
C6H8O4
IUPAC Name:
dimethyl (Z)-but-2-enedioate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 276-328 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: ethanol
Concentration / amount:
1 % test substance in ethanol for all administrations
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

See Attachment for results.

Applicant's summary and conclusion

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.