Registration Dossier
Registration Dossier
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EC number: 942-381-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- other: Amendment
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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
- Reference substance name:
- 72008-25-4
- EC Number:
- 615-703-3
- Cas Number:
- 72008-25-4
- IUPAC Name:
- 72008-25-4
- Details on test material:
- - Name of the test substance used in the study report: Asta-C6-Acetal
- Physical state: Liquid, achromatic
- Storage: Refrigerator, exclusion of light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Age at study initiation: young adults
- Weight at study initiation: 3.66 - 3.85 kg
- Housing: single housing, in stainless steel wire mesh cages with grating, floor area 3000 cm2; no bedding in the cages, sawdust in the waste trays
- Diet: 130 g/day of Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water: 250 mL tap water/day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air: central air-conditioning
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL to the conjunctival sac of the right eyelid
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Both eyes were examined before application of the test substance for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
- Weight determination: shortly before application of the test substance
- The test substance was not washed out.
- Readings: 1, 24, 48 and 72 h after application
- A check for general observation and mortality was made twice each working day and once on weekends and on public holidays.
- SCORING SYSTEM: Cornea, conjunctivae, chemosis and iris effects as stated in the OECD 405 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test the substance is considered to be not corrosive or irritating to the eye.
- Executive summary:
The potential to cause damage to the conjunctiva, iris or cornea was assessed in an OECD 405 guideline study (in compliance with GLP) in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0. The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris, chemosis, and 0.9 for conjunctivae redness (in which two animals had a score of 1 and one a score of 0.7). The findings were reversible withing 72 hours after application. It was concluded that the test substance was not irritating to the eye.
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