Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

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:
The test was conducted at a time where the LLNA method was not established.

Test material

Constituent 1
Chemical structure
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 2-chloroacetate
Details on test material:
- Name of test material (as cited in study report): the ethylester of MCA (EMCA

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
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
Route:
other: no data
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

Of the 20 animals treated, 5 guinea pigs were sensitized. EMCA is concluded to be a sensitizer to humans.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Of the 20 animals treated, 5 guinea pigs were sensitized. EMCA is concluded to be a sensitizer to humans.
Executive summary:

The sensitisation effect of monochloro acetic acid ethyl ester (EMCA) was tested in the Maximization Test (according to Magnusson and Kligman) on 30 guinea pigs (Dunkin-Hartley). 10 of these animals served as controls. EMCA was dissolved in 50% ethanol, and for induction 0.5% ethyl chloroacetate was administered on day 0 of the test. On day 7, 2.5% was given. On test days 21 to 35, 2.5, 0.25 and 0.025% were applied. Examination of theses animals was carried out 48 to 72 hours after the end of the test. Of the 20 animals treated, 5 guinea pigs were sensitized. EMCA is concluded to be a sensitizer to humans.