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Toxicological information

Eye irritation

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Feb. 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation:8-12 weeks
- Weight at study initiation: 2.3 -2.5kg
- Housing: single in suspended cages
- Diet (e.g. ad libitum): Purina rabbit chow (diet #5321) ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h / 12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
substance not washed out
Observation period (in vivo):
28days
Observations after 1h, 24h, 48h, 72h, 7days, 14days, 21days, 28days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize + scoring of ocular discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: pannus observed on days 7 (2 animals) and 14 (1 animal). Mean individual scores = 2 - 2 - 2
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days (2 animals), 21 days (1 animal)
Remarks on result:
other: Mean individual scores = 2 - 2 - 2.7
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 28 days (1 animal)
Remarks on result:
other: Mean individual scores = 3 - 4 - 2
Irritant / corrosive response data:
Corneal opacity, noted in 3 of 3 eyes, persisted to day 28 in one eye. Iritis, noted in 3 out of 3 eyes, cleared by day 7. Conjunctival irritation, noted in 3 out of 3 eyes, persisted to day 28 in one eye.
Other effects:
There were no abnormal physical signs noted during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Due to the irreversible effects in 1 animal, the test substance is considered corrosive to the eye.
Executive summary:

Three rabbits were doses with 0.1 ml of butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate placed into the left conjunctival sac of each rabbit. The eyes remained unwashed. The eyes were examined and scored by the Draize technique at 1 hour post dose and on days 1, 2, 3, 7, 14, 21 and 28. Body weight were recorded pretest. Corneal opacity, noted in 3 of 3 eyes, persisted to day 28 in one eye. Iritis, noted in 3 out of 3 eyes, cleared by day 7. Conjunctival irritation, noted in 3 out of 3 eyes, persisted to day 28 in one eye. There were no abnormal physical signs noted during the study. Under the conditions of this study, the test article is corrosive based on persistant corneal opacity noted through day 28.