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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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Title 21, Code of Federal Regulations, 191.11.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Varamide A-7

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL or 0.1 g of the undiluted test substance was instilled into one eye of each rabbit. The other eye served as control.
- Concentration (if solution): 100% (undiluted)
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
24, 48, 72 h and 7 and 14 d.
Number of animals or in vitro replicates:
Six
Details on study design:
0.1 mL or 0.1 g of the undiluted test substance was instilled into the one eye of each animal, and the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48 and 72 h and 7 and 14 d after instillation. Any residue of the test substance and accumulated discharge are flushed from the eye each time they are scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
overall irritation score
Remarks:
Undiluled test substance
Basis:
animal: 1 to 6
Time point:
24 h
Score:
11.33
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
overall irritation score
Remarks:
Undiluted test substance
Basis:
animal: 1 to 6
Time point:
48 h
Score:
7.67
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
overall irritation score
Remarks:
Undiluted test substance
Basis:
animal: 1 to 6
Time point:
72 h
Score:
5.67
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
overall irritation score
Remarks:
Undiluted test substance
Basis:
animal: 1 to 6
Time point:
7 d
Score:
3.33
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
overall irritation score
Remarks:
Undiluted test substance
Basis:
animal: 1 to 6
Time point:
14 d
Score:
2.33
Reversibility:
not fully reversible within: 14 d

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions, the undiluted test substance can be assessed to be a irritating to eyes.
Executive summary:

The ocular irritation potential of the test substance was investigated using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11. The substance (0.1 mL or 0.1 g) was instilled into one eye of each of six rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and conjunctivae at 24, 48, 72 h, then 7 and 14 d. Irritation response in the conjunctiva was observed in terms of redness, chemosis and discharge. The mean conjunctival redness score was 2 in 4/6 animals. The mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h, then 7 and 14 d. Except for conjunctival redness, which was the most prominent response and was present in 3/6 animals, irritation in the remaining eye (chemosis and discharge) reduced to almost 0 by Day 14. Under the conditions of the study, the undiluted test substance was irritating to eyes (Casey, 1976).