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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:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Vat Blue 20

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
Healthy New Zealand White rabbits (Porton- strain) aged 11-12 weeks with average body weights of 2.57 kg (males) and 2.19 Kgs. (femals), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the study.

Husbandry•
The rabbits were caged singly in. an experimental room maintained at a temperature of 20°C (± 1) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad libitum. Sterile filtered water was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 second in 3 animals, 24 hours in 3 animals
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male and 3 female rabbit
Details on study design:
The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
The eyes of the experimental animals were examined, and found normal prior to the test. 100 mg. of the test compound were instilled into the conjunctival sec of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 mL of warm water The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.. Corneal damage was assessed after staining with fluorescein.

Results and discussion

In vitro

Other effects / acceptance of results:
3 rinsed animals
3 non-rinsed animals

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 non-rinsed animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A very slight to slight conjunctival reaction was seen in all treated eyes one hour after application of the compound. Redness was still present in 4/6 eyes at 24 hours. These had returned to normal by 48 hours (2 eyes) and 72 hours (2 eyes).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not irritating to eyes.
Slight conjunctival effects were seen 1 hour after test item instillation. This effect was avoided by rinsing of the eyes.
Executive summary:

An eye irritation study after single application was performed to determine the irritant potency of the test item on the rabbit eyes in New Zealand White rabbits. The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were held open for a few seconds. The right eye was not treated and served as a control. In three of the six rabbits approximately 30 seconds after treatment both eyes were rinsed with physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; and 3 days.

A very slight to slight conjunctival reaction was seen in all treated eyes one hour after application of the compound. Redness was still present in 4/6 eyes at 24 hours. These had returned to normal by 48 hours (2 eyes) and 72 hours (2 eyes).

In conclusion, the test item is not irritating to eyes.

Slight conjunctival effects were seen 1 hour after test item instillation. This effect was avoided by rinsing of the eyes.