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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
Study period:
From 14 June to 29 May, 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: section 191.12 of the final order, Enforcement Regulation, Federal regulation vol. 29 September 1964
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
some parameters not specified in study report (exact species, washing performed, vehicle used)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
No data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks:
not reversible in 1/3 animals
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal: #2 & #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #1 & #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Table: Eye irritation results.

Day 1 Day 2 Day 3 Day 4 Day 7

Animal 1

Corneal opacity 1 1 1 1 1
Iritis 1 1 1 0 0
Conjunctival redness 2 1 1 1 0
Conjunctival chemosis 2 1 1 0 0
Animal 2 Corneal opacity 1 1 1 1 0
Iritis 1 1 0 0 0
Conjunctival redness 2 1 1 1 0
Conjunctival chemosis 2 1 1 0 0
Animal 3 Corneal opacity 1 1 1 1 0
Iritis 1 1 0 0 0
Conjunctival redness 2 1 1 0 0
Conjunctival chemosis 2 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (Eye irritant) based on CLP Regulation (EC no. 1272/2008)
Conclusions:
Irritating to the rabbit eye
Executive summary:

The eye irritation potential of the substance was evaluated in an experimental study performed according to the criteria specified in paragraph 191.12 of the final Order, Enforcement regulations, federeal regulation, federal registror vol. 29, N 192, P.13009, 17 september 1964, a method similar to the OECD Guideline 405. The test item was applied directly into the the eye of three albino rabbits and the site was monitored for corneal opacity, iritis, conjunctival redness and chemosis according to Draize scores, immediately after application and then at 1, 2, 3 and 7 days after application.

Corneal opacity scores were 1.0 in all animals at all time points, with the exception of the 7 day reading, which was 0.0 in two out of the three animals. Iritis scores were 1.0 in all animals both immediately after application and after 1 day; 2 days after application, the iritis scores were 0.0 for two animals and 1.0 for one animal, after which time the iritis scores were 0.0 for all animals until end of study period. Conjunctival redness scores were 2.0 in all animals immediately after application; 1.0 in all animals after both 1 and 2 days; 0.0 (1 animal) and 1.0 (2 animals) after 3 days, and 0.0 among all animals after 7 days. Conjunctival chemosis scores were 2.0 among all animals immediately after application; 1.0 among all animals after 1 day; and 1.0 (2 animals) and 0.0 (1 animal) after 2 days; all animals had scores of 0.0 after 3 and 7 days.

The mean (24/48/72 hour) scores for the four parameters examined can be interpreted for each animal as follows: corneal opacity = 1.0 (all animals); iritis = 0.33 and 0.67 (2 and 1 animals, respectively); conjunctival redness = 0.67 and 1.0 (1 and 2 animals, respectively); chemosis = 0.33 and 0.67 (1 and 2 animals, respectively).

It is apparent that the test item is irritating to the rabbit eye, however, it should be noted that all parameters were reversible within a 7-day window with the exception of a corneal opacity score of 1.0 in one rabbit only after 7 days.