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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented company data which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Chemical identifiers as per section 1.1 and 1.2.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
not specified
Duration of treatment / exposure:
Eye examinations: 1, 24, 48, 72h and 7 and 14 days after the administration (p.a.) of the test substance.
Observation period (in vivo):
Eye examinations: 1, 24, 48, 72h and 7 and 14 days after the administration (p.a.) of the test substance.
Number of animals or in vitro replicates:
1: The approximate equivalent of 0.1ml of test substance was instilled into one conjunctival sac of 1 New Zealand White Rabbit. As the
test substance was found to be severely irritating, the test substance was not administered to further rabbits.

Results and discussion

Any other information on results incl. tables

General signs of toxicity: No symptoms of systemic toxicity were observed in the animal during the test period and no mortality occurred.

Eye examinations:

Cornea: Corneal alterations were observed from 1h p.a. until 7d p.a.

Iris: A sluggish reaction to light was noted 72h p.a.

Conjunctiva, redness: Slight to pronounced redness was observed from 1h p.a.until 7d p.a.

Conjunctiva, chemosis: Severe swelling was notes from 1h p.a. until 72h p.a., decreasing to obvious swelling 7d p.a.

Additional findings: Ocular discharge was noted from 1h p.a. until 7d p.a.

Applicant's summary and conclusion

Conclusions:
The test substance is irritating to eyes and a classification is required ( R36 irritating to eyes).
Executive summary:

The test substance is irritating to eyes and a classification is required ( R36 irritating to eyes).