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other: GLP compliant guideline study, available as unpublished report.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-C9-Diol-Natrium
- Physical state/appearance: liquid, red-brown
- Storage conditions: 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 adult animals
- Weight at study initiation: male animal: 3.48 kg; female animals: 2.70 kg and 2.78 kg
- Housing: One animal per cage (type: stainless steel wire mesh cages with grating, floor area: 3000 cm2)
- Diet: Kliba-labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: tap water (about 250 mL/animal/day)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Substance was not washed out
Observation period (in vivo):
72 hour
Number of animals or in vitro replicates:
3 (1 male and 2 female animals)
Details on study design:
- Readings: 1 h, 24 h, 48 h, and 72 h, after instillation
- A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1 and # 3
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24-48-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
other: mean 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24-48-72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the performed eye irritation study, the test substance was determined to be not 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. Three white Vienna rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0 (all animals) for corneal opacity and iris, 0, 0.3, and 0 for chemosis and 1, 1, and 0.7 for conjunctivae redness for animal 1, 2, and 3 respectively. The eye findings observed for chemosis were reversible within 48 hours and the findings for conjunctivae redness 72 hours after instillation. Based on these findings it is concluded that the test substance is not irritating to the eye.