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: No flaws compromising the reliability were observed when the study was evaluated using the ECVAM "ToxRTool"

Data source

Reference
Reference Type:
publication
Title:
Studies on eye irritation caused by chemicals in rabbits -1. A quantitative structure-activity relationships approach to primary eye irritation of chemicals in rabbits-
Author:
Sugai S et al
Year:
1990
Bibliographic source:
The Journal of Toxicological Science, Vol. 15, 245-262, 1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing: metal cages (39x40x44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co., Tokyo, Japan)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25+/- 1°C
- Humidity (%): 55 +/-5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12 hrs light


IN-LIFE DATES: From: To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 ml per animal
Duration of treatment / exposure:
1 administration into conjunctival sac of left eye
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score (Draize et al. 1944).

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all
Score:
> 1 - < 42.8
Max. score:
110
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
II: moderate or severe irritant
Corneal involvement or irritation that persists for more than 24 hrs but recovers within 21 days after treatment

Applicant's summary and conclusion

Interpretation of results:
other: moderate to severe irritant
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Styrene oxide was classified as moderate to severe irritant.
Executive summary:

In a primary eye irritation study similar to OECD Guideline 405, 0.1 mL of 1,2-epoxyethylbenzene (styrene oxide) was instilled into the conjunctival sac of three Japanese White rabbits. Animals then were observed for 21 days. Irritation was scored by the method of Draize. Styrene oxide was classified as moderate to severe irritant as it provoked corneal involvement or irritation that persisted for more than 24 hours but recovers within 21 days after treatment.