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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Restriction : no data on purity, no quantitative data for ETU

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, Murata K, Kitagaki T, and Tomita I.
Year:
1990
Bibliographic source:
The Journal of Toxicological Sciences, Vol. 15, 245-262.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no score are available.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Other name = Ethylenethiourea (ETU)
ETU was purchased from Wako Pure Chemical Industry (Osaka, Japon), Aldrich Chemical Company (Winsconsin, USA), Dojindo Laboratories (Kumamoto, Japan) orTokyo Kasei Kogyo Co. (Tokyo Japan).

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white (females)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Shizuoka, Japan
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing: in metal cages (39 x40x44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co., Tokyo Japan), ad libitum
- Water (e.g. ad libitum): not precised, 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): 12/12

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
The chemical (Solid = 100 mg ; liquid = 0.1 ml) was placed into conjunctival sac of the left eye.
The right eye was served as a blank.
Duration of treatment / exposure:
1 single administration
Observation period (in vivo):
1, 4, 24, 48, 72, 96 hr, and 7, 14, 21 days after the treatment of chemical.
Number of animals or in vitro replicates:
3 animals/ group
Details on study design:
REMOVAL OF TEST SUBSTANCE : no data
SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score (1944).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Draize score
Basis:
mean
Time point:
24/48/72 h
Score:
<= 7
Max. score:
110
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Minimal irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: data not reported
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: data not reported
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: data not reported
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: data not reported
Irritant / corrosive response data:
There was no quantitative data for ETU.
It was a chemical which inducing no or mild damage recovering within 24 hr. This score distributed from 0 up to 7.0 .
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
ETU was in class I, it was a non or mild irritant.
Executive summary:

The Draize eye irritation test has been used as an attempt to predict ocular irritancy of chemicals.The eye irritation ratings were made in three classes on the basis of the recovery time of corneal and conjunctival damages. A three-class discrimination was made as follows; class I included chemicals which induced the damages recovering within 24 hr, class II included chemicals which induced the damages persisting for more than 24 hr but recovering within 21 days, class III included chemicals which induced the damages not recovering within 21 days. ETU was a non or mild irritant (class 1).