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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)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Powdered formulation.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: a standard laboratory diet was provide ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Health check: prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Nine rabbits: six rabbits for unwashed eyes and three addtional rabbits whose eyes were washed after instillation.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in three animals, the treated eye was rinsed with 20 ml lukewarm water.
- Time after start of exposure: after half a minute.

OBSERVATION TIME
The eyes were inspected after 24, 48 and 72 hours.

SCORING SYSTEM:
Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
iris score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
conjunctivae score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 2
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
chemosis score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 2
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritant / corrosive response data:
The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

Any other information on results incl. tables

Reactions - unwashed eyes

Animal Reaction 24 hrs 48 hrs 72 hrs
Male 701 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 702 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 703 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 704 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 705 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 706 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0

Reactions - washed eyes

Animal Reaction 24 hrs 48 hrs 72 hrs
Male 707 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 708 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0
Male 709 Cornea (A) density 0 0 0
(B) area 0 0 0
A×B×5 0 0 0
Iris (C) 0 0 0
C×5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)×2 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating
Executive summary:

Nine rabbits (New Zealand White Rabbits) were used in the test: six animals for unwashed eyes and three animals whose eyes were washed after instillation. Prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.

100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. In three animals, the treated eye was rinsed after half a minute. The eyes were inspected after 24, 48 and 72 hours. Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 0, thus, the test item was judged to be non irritant, according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are strictly comparable to those reported into the OECD guideline, thus it is possible to re-evaluate the results in accordance with the CLP Regulation (EC 1272/2008).

None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).