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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
The substance was suspended in tap water before the administration.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Strain: Porton
Age at study initiation: 9-13 weeks
Weight at study initiation: 2.36 Kgs. (males) and 2.55 Kgs (female)
Housing: maintained under a semi-barrier system. Caged singly in an experimental room
Diet: bred on the premises and maintained under a semi-barrier system. Commercial irradiated diet (Styles-Oxoid) was fed ad lib
Water: ad libitum, Sterile filtered
Acclimation period: acclimatized in the test area for one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
Temperature: 20 °C +/- 1°C
Humidity: 50-70 %
Photoperiod (hrs dark / hrs light): from 08.00 - 18.00 hours artificial light

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
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.
Observation period (in vivo):
The eyes of the experimental animals were examined and found normal prior to the test.
14 days
Number of animals or in vitro replicates:
6 rabbits (3 male, 3 female)
Details on study design:
The test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes- of three of the rabbits with warm water for 1 minute.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal:
Remarks:
all of six animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: all of the six animals
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: six animals/6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal: one animal/6
Time point:
48 h
Score:
0.17
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal: all otf the six animals
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: two anilmals/6
Time point:
24 h
Score:
0.83
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal: one animals/6
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: six animals
Time point:
72 h
Score:
0
Irritant / corrosive response data:
A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (l/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).

Applicant's summary and conclusion

Interpretation of results:
other: minimal eye irritant
Remarks:
Criteria: Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
Conclusions:
minimal eye irritant in the albino rabbit
Executive summary:

The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous

Substances Labelling Act Sect. 191.11 (February 1965).

In to the left eye of six rabbits (3 male, 3 female) 100 g of the test compound was instilled into the conjunctival sac. The eyelids were then held closed for 1 second. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Observation was done at 24 and 72 hours and 14 days.

A very slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. These reactions subsided slowly over the subsequent days until all had returned to normal by 48 hours (1/3 washed eyes), 6 days (2/3 washed eyes), 10 days (2/3 unwashed eyes) and 14 days (1/3 unwashed eyes). Staining of the conjunctivae by the compound was seen in all three unwashed eyes for up to 72 hours. Transient damage to the surface epithelium of the cornea was seen at one hour only in one rabbit (No.12).

The substance is considere minimal eye irritant in the albino rabbit.