Registration Dossier
Registration Dossier
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EC number: 426-400-9 | CAS number: 170222-39-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 28 to November 4, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- Red RA 10463
- IUPAC Name:
- Red RA 10463
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 28.2 mg ± 1.0 mg (ca. 0.1 ml)
- Duration of treatment / exposure:
- Single exposure; not removed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- - 2 % fluorescein in water was applied 24 hours after application in order to determine corneal epithelial damage. After readings for % damaged area were taken, the eye was rinsed with ca. 50 ml tepid tap water to remove substance.
- Observations: mortality (twice daily), toxicity (daily), body weight (study commencement), irritation parameters (24, 48 and 72 hours after application): corneal opacity, area of corneal irritation, iritis, conjunctival irritation (redness, chemosis, discharge)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- - Slight dulling of the normal lustre of the cornea (score = 0) and epithelial damage (10 % on 35 % of the corneal area) were observed in animals #1 and #3 only, 24 hours after application only.
- Iridic irritation was observed in animal #2 only, 1 hour after application, and in animal #1 only at 24 hours after application.
- Conjunctival irritation of redness, chemosis and discharge had completely resolved within 7 days in all animals.
- No evidence of corrosion or systemic toxicity were apparent. - Other effects:
- - Remnants of the test item in the eye: all three animals at 1 hour and 24 hours after application; additionally, animal #2 at 48 hours after application. These remnants were not removed with rinsing after 24 hour interval reading.
- Purple staining of the fur on the head and paws, caused by the test item: all three animals at 1 hour and 24 hours after application.
- Haemorrhage in the sclera of the eye, where remnants of the test item had been noted previously: animal #2 at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: cat. 2 eye irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Irritating to eyes.
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