Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment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:
1994
Report Date:
1994
Reference Type:
other: Amendment
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.