Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

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

Test animals / tissue source

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

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 - 70 %
- Air changes: approximately 15 changes/hour.
- Photoperiod: 12 hrs dark / 12 hrs light

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 animals.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not rinsed.

SCORING SYSTEM:
The eyes were inspected after 30 min., 24, 48 and 72 hours.
Reading scores 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: 3/3
Time point:
24/48/72 h
Score:
> 1 - < 3
Irritation parameter:
iris score
Basis:
animal: 2/3
Time point:
24/48/72 h
Score:
>= 1 - < 1.5
Irritation parameter:
conjunctivae score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 2
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
> 2
Irritant / corrosive response data:
The irritation score resulted to be 51.4.

Any other information on results incl. tables

Animal no Reaction 30 min 24 hrs 48 hrs 72 hrs Mean 24/48/72 hrs
304 Cornea opacity 0 2 3 3 2.67
Iris 0 1 1 2 1.33
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 3 3 3.00
305 Cornea opacity 0 1 3 3 2.33
Iris 0 0 1 2 1.00
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 3 3 3.00
306 Cornea opacity 0 2 3 2 2.33
Iris 0 0 1 1 0.67
Conjuntival chemosis 0 3 3 2 2.67
Conjuntival redness 1 3 2 2 2.33

Animal no Reaction 30 min 24 hrs 48 hrs 72 hrs
304 Cornea (A) density 0 2 3 3
(B) area 0 4 4 4
AxBx5 0 40 60 60
Iris (C) 0 1 1 2
Cx5 0 5 5 10
Conjunctiva (D) secretion 1 1 1 1
(E) swelling 0 3 3 2
(F) redness 1 3 3 3
(D+E+F)x2 4 14 14 12
305 Cornea (A) density 0 1 3 3
(B) area 0 4 4 4
AxBx5 0 20 60 60
Iris (C) 0 0 1 2
Cx5 0 0 5 10
Conjunctiva (D) secretion 1 1 1 2
(E) swelling 0 3 3 2
(F) redness 1 3 3 3
(D+E+F)x2 4 14 14 14
306 Cornea (A) density 0 2 3 2
(B) area 0 4 4 4
AxBx5 0 40 60 40
Iris (C) 0 0 1 1
Cx5 0 0 5 5
Conjunctiva (D) secretion 1 1 1 2
(E) swelling 0 3 3 2
(F) redness 1 3 2 2
(D+E+F)x2 4 14 12 12

Applicant's summary and conclusion

Interpretation of results:
other: Eye. Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008)
Conclusions:
Eye irritating
Executive summary:

The eye irritation potential of the test item was tested using three rabbits (New Zealand white Rabbits). 100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. The left eye served as control.

The eyes were inspected after 30 min., 24, 48 and 72 hours. Treated eyes were not rinsed after application of the test item.

Reading scores 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 51.4.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were in the range of 1 - 3 for corneal opacity, 1 - < 1.5 for iritis, higher than 2 for both conjunctival redness and chemosis, in at least two out of three rabbits. No information about the reversibility was available.

Based on the effects observed, the substance is considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2, H319) of the CLP Regulation (EC 1272/2008) is considered as appropriate.