Registration Dossier
Registration Dossier
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EC number: 213-107-4 | CAS number: 924-50-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: EG Guideline B.6 Akute Toxizität Sensibilisierung der Haut der Richtlinie 84/449/EWG
- Qualifier:
- according to guideline
- Guideline:
- other: Richtlinie 83/467/EWG
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-Methylcrotonsäuremethylester
- IUPAC Name:
- 3-Methylcrotonsäuremethylester
- Reference substance name:
- Methyl 3-methyl-2-butenoate
- EC Number:
- 213-107-4
- EC Name:
- Methyl 3-methyl-2-butenoate
- Cas Number:
- 924-50-5
- Molecular formula:
- C6H10O2
- IUPAC Name:
- methyl 3-methylbut-2-enoate
- Test material form:
- other: clear liquid
- Details on test material:
- Purity: 97.3%
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- Sex: female, Feeding: ERKA-Mischfutter Nr. 8300 für Meerschweinchen und Kaninchen ad libitum., ID: KMnO4 and numbering of cages, in groups: 5 animals, Cage: Makrolon cage (type 4),Room temperature: 22+/- °C, Humidity: 50+/- 20 %, light/dark: 12h/12h, Acclimatisation: 5 days before exeriment started, Strain: DHPK (SPF lac), Source: Hoechst AG, Kastengrund, SPF- Zucht, Storage: 4°C and dark, fully air conditioned
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Number of animals
Testing of the primary not irritating concentration 6
Testing of the intradermal tolerance 3
Monitoring group 5
Control group 5
Treated group 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not sensitising to the skin.
- Executive summary:
24 and 48 h after the bandage was removed neither the treated nor the control animal showed a reaction.
The animals showed during the whole experiment no intoxicationn symptoms.
The body weight was not significantly affected.
The intradermal injection led to medium to severe erythema and medium edema. Two days after the administration side of the injection was callous and greenish. Necroses appeared one week after administration of Freund´schem Adjuvans.
It can be concluded that Dimethylacrylic acid methyl ester is not sensitising
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