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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-07 to 1985-05-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only the translation of the study report is available. All scientific necessary information for evaluation is available. The study was performed according to OECD guideline 405.

Data source

Reference
Title:
Unnamed
Year:
1985
Report Date:
1985

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 material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Praeparat EK, Acetic acid (2-benzothiazolylthione)
- Physical state: fine, white powder
- Purity: 100%
- Purity test date: n.a.
- Impurities (identity and concentrations): n.a.
- Lot/batch No.: n.a.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 (3 males + 3 females)
Details on study design:
In order to assess the eye irrtating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control. The treated eye remains unwashed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours after treatment
Score:
1.78
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 -72 hours after treatment
Score:
0.44
Max. score:
1
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24- 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 14 days after treatment
Remarks on result:
other: In one animal a score of 2 was determined at day 14 after treatment. In one other animal the severity progessed up to score 4 at day 14 after treatment and it is not expected to be reversible within 21 days.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours after treatment
Score:
0.88
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: 14 days after treatment in one animal the score was still 1; in one other animal the iris could not be assessed due to the cornea opacity.
Irritant / corrosive response data:
In order to assess the eye irritating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control. The treated eye remains unwashed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48, 72 and 96 hours after application of test item and additionally after 7 and 14 days due to some findings made. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:
No mortality or signs of systemic toxicity occurred.
Hyperemia of the conjunctiva was observed in all animals (score 1-2). In two of six animals this change was not reversible within the observation period of 14 days.
Chemosis of the conjunctiva (score1) was observed in all animals 24 hours after application. This effect was reversible within 72 hours.
Diffuse Corneal opacity areas (score 1, 2, 3) were observed in two of the six animals 48 hours after application and in all animals at 72 hours after application of the test substance. This observation was reversible in 4 animals by end of the 14-day observation period. The corneal opacity of the remaining two animals progressed up to complete opacity (score 4) in one case.
Hyperemia of the iris (score 1-2) was observed in 5 animals 48 hours after application and in all animals after 72 hours after application of the test substance. In one rabbit this observation was not reversible within the observation period and in a second rabbit the iris could not be evaluated due to the complete opacity of the cornea.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the test substance has to be classified Category 1 "causes serious eye damage", as the damage was not reversible within the observation period of 14 days and is not expected to be reversible within 21 days.
Executive summary:

In order to assess the eye irritating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of reach rabbit. The untreated eye serves as control. The treated eye remains unwashed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48, 72 and 96 hours after application of test item and additionally after 7 and 14 days due to some findings made. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia of the conjunctiva was observed in all animals (score 1-2). In two of six animals this change was not reversible within the observation period of 14 days.

- Chemosis of the conjunctiva (score1) was observed in all animals 24 hours after application. This effect was reversible within 72 hours.

- Diffuse Corneal opacity areas (score 1, 2, 3) were observed in two of the six animals 48 hours after application and in all animals at 72 hours after application of the test substance. This observation was reversible in 4 animals by end of the 14-day observation period. The corneal opacity of the remaining two animals progressed up to complete opacity (score 4) in one case.

- Hyperemia of the iris (score 1-2) was observed in 5 animals 48 hours after application and in all animals after 72 hours after application of the test substance. In one rabbit this observation was not reversible within the observation period and in a second rabbit the iris could not be evaluated due to the complete opacity of the cornea.

Based on the results of this study the test substance has to be classified Category 1 "causes serious eye damage", as the damage was not reversible within the observation period of 14 days and is not expected to be reversible within 21 days.