Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
3-Aminocrotonsäuremethylester, white powder, content and identity not certified

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Results of the study:

                              irritation grade according to Draize et al.    
   1 h  24 h   48 h      72 h     7 d         Irritation index
 animal  erythema  edema   erythema   edema   erythema   edema   erythema   edema   erythema  edema    erythema  edema 
 1  2
 2  2 0
 3  1

Applicant's summary and conclusion

Executive summary:

500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize and the indices were calculated in accordance with OECD-Guideline 404.

In this skin irritation study methyl 3 -aminocrotonate was slightly irritating to the skin. No corrosive potential could be detected.