Registration Dossier
Registration Dossier
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EC number: 202-501-1 | CAS number: 96-34-4
Skin sensitisation
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: Magnusson and Kligman method but no data on GLP. Evaluation of cross reactivity to monochloro acetic acid methyl ester.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- at the time of testing the LLNA method was not established
Test material
- Reference substance name:
- Ethyl chloroacetate
- EC Number:
- 203-294-0
- EC Name:
- Ethyl chloroacetate
- Cas Number:
- 105-39-5
- Molecular formula:
- C4H7ClO2
- IUPAC Name:
- ethyl chloroacetate
- Details on test material:
- Monochloro acetic acid ethyl ester (EMCA) and cross reactivity for monochloro acetic acid methyl ester
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- other: ethanol 50%
- Concentration / amount:
- Induction: day 0: 5% EMCA ethanol 50%
day 7: 2.5% EMCA ethanol 50%
Challenge: days 21-35: 2.5, 0.25 and 0.025%
Challengeopen allclose all
- Vehicle:
- other: ethanol 50%
- Concentration / amount:
- Induction: day 0: 5% EMCA ethanol 50%
day 7: 2.5% EMCA ethanol 50%
Challenge: days 21-35: 2.5, 0.25 and 0.025%
- No. of animals per dose:
- Experimental group: 20 animals
Control group: 10 animals
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: 48-72 h
- Group:
- test chemical
- Dose level:
- 2.5-0.025%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 48-72 h. Group: test group. Dose level: 2.5-0.025%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Any other information on results incl. tables
EMCA showed the capacity to sensitize 5 of 20 guinea pigs. On day 49, cross-reaction patterns to the methylester of MCA (MMCA) were studied in four animals. All animals reacted to MMCA (5 %-0.5%).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- EMCA is concluded to be a sensitizer to humans. Cross reactivity to MMCA may occur.
- Executive summary:
The substance monochloro acetic acid ethyl ester (EMCA) was tested in the Guinea Pig Maximization Test (Magnusson and Kligman) to determine its possible sensitizing potential. EMCA showed the capacity to sensitize 5 of 20 guinea pigs. On day 49, cross-reaction patterns to the methyl ester of MCA (MMCA) were studied in four animals. All animals reacted to MMCA (5%-0.5%). EMCA is concluded to be a sensitizer to humans. Cross reactivity to MMCA may occur.
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