Registration Dossier
Registration Dossier
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EC number: 455-940-8 | CAS number: -
Eye irritation
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:
- 2 005
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Chemical identifiers as per section 1.1 and 1.2.
Constituent 1
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).
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