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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:
other company data
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Trade name 2076 BENZANIL RUBINE 2BL
Purity: 55-60%
Specific details on test material used for the study:
The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1. Purity was cited at 55-60% (impurities sodium chloride and water).

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 New Zealand White rabbits (2 females and 1 male), supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK, were used. At the start of the study the animals weighed 2.73 -2.90 kg and were 12 – 16 weeks old.
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.

Test system

Vehicle:
not specified
Amount / concentration applied:
One rabbit was initially treated. A volume of 0.08 ml of the test material, which was found to weight approximately 100 mg was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.
After consideration of the ocular responses produced in the first treated animal, 2 additional animals were treated. In order to minimize pain on application of the test material, one drop of local anesthetic was instilled into both eyes of these animals 1 – 2 minutes before treatment.
Duration of treatment / exposure:
The upper and lower eyelids were held together for about 1 second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 hr following treatment, according to Draize (1977) “Dermal and eye toxicity tests.”
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Additional observations were made on Day 7 and 14 to assess the reversibility of the ocular effects.
Number of animals or in vitro replicates:
3 rabbits ( 2 females and 1 male)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Purple staining of the conjunctive was noted in all treated eyes one hour after treatment and prevented accurate evaluation of conjunctive redness. Purple staining of the iris was noted in 2 treated eyes 1 hour after treatment and prevented accurate evaluation of iridial inflammation in one treated eye at this time. Purple staining of the cornea was noted in 2 treated eyes 1 hour after treatment, in the conjunctivae of all treated eyes at the 24 and 48 hour observation and persisted in the conjunctivae of two treated eyes at the 72 hour observation.
Dulling of the normal luster of the corneal surface was noted in two treated eyes at 1 hr observation. Diffuse corneal opacity was noted in 2 treated eyes at the 24 and 48 hour observations and in 1 treated eye at the 72 hour observation.
Iridial inflammation was noted in 2 treated eyes at the 1, 24 and 48 hr observations.
Slight conjunctival chemosis (swelling) and severe discharge were noted in all treated eyes at the 1-hour observation. Moderate conjunctival irritation was noted in 2 treated eyes at the 24 hour observation and in one treated eye at the 48 hour observation. Minimal conjunctival irritation was noted in one treated eye at the 24 hour observation, 2 treated eyes at the 48 hour observation, all treated eyes at the 72 hour observation and in 1 treated eye at the 7 day observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, BENZANIL RUBINE 2BL, did not produce positive criteria in any rabbit according to EU labelling regulations. No symbol and risk phrase are therefore required.
Executive summary:

The study was performed to assess the irritancy potential of the test material following a single application to the rabbit eye, according to OECD 405 guideline. 3 New Zeeland rabbits (2 females and 1 male) were tested by a single administration of the test substance.

A volume of 0.08 ml (100 mg) of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.

Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 hr following treatment, according to Draize (1977) “Dermal and eye toxicity tests.”

The mean scores of corneal opacity, iritis, conjunctival redness, and conjunctival oedema do not meet the classification criteria. All of the effects reverse within 21 days.