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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Monochloro acetic acid ethyl ester (EMCA) and cross reactivity for monochloro acetic acid methyl ester

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 group
Dose level:
2.5-0.025%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading:

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.