Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
A single semi-occlusive application of 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene to intact rabbit skin for 4 hours was conducted.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): m-xylylene bis(citraconimide)
Batch no.: BOM pp2
Purity: 87± 3% (m/m); see CoA attached
Other: m-Xylylene bis(itaconimide) 2-5%
appearance: brown powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
4 days
Number of animals:
3 animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Because the test substance did not induce skin irritation, no classification is needed.
Executive summary:

In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be not irritating to rabbit skin. No relevant systemic intolerance reactions were observed.