Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1989
Reliability:
1 (reliable without restriction)
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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: powder
Batch no.: BOM pp2
Purity: 87 ± 3% (m/m); see CoA attached
Other: m-Xylylene bis(itaconimide) 2-5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: no vehicle used
Controls:
no
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
After placing the test substance into the lower everted lid of one eye, eyelids were gently held together for one second before releasing.
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
other: see above
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
other: see above
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
other: see above
Other effects:
Due to the severity of the effects the animal was killed 24
hours after instillation.
Corneal opcity covered up to approx. the whole area. Blanching of the eyelids and a copious discharge were seen.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Because of the premature killing of the animal no judgement can be made on reversibility. The test substance was highly irritating and should be classified as 'risk of serious damage to eyes'.