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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:
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:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The test substance was assessed for mucous membrane irritation in rabbits.
- Short description of test conditions: The test substance was applied into the conjunctiva sack of two animals (50 mg). Animals were observed for 7 days.
- Parameters analysed / observed: reddening and swelling of conjunctiva, corneal opacity, iritis
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
- Weight at study initiation: 3 - 4 kg
- Housing: individually

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
An increasing amount of discharge from the eye was observed during the entire period of observation after the examination.

Any other information on results incl. tables

Table 1:Results of eye irritation study

Rabbit No.

Organ investigated

hours/days after application and rinsing

1 h

24 h

48 h

72 h

7 d

1

Cornea*

2/4

2/4

2/4

2/4

2/4

Iris

1

1

2

2

2

Conjunctivae (redness)

2

1

2

3

2

Conjunctivae (swelling)

2

1

2

2

2

2

Cornea*

3/4

4/3

4/3

4/3

4/3

Iris

2

2

2

2

2

Conjunctivae (redness)

3

2

2

3

3

Conjunctivae (swelling)

3

3

2

2

2

* area/degree of damage (area: 1 = ¼, 2 = ½, 3 = ¾, 4 = whole region of cornea)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Severe damages to the eye were observed after test substance exposure and examination at day 7 provided no evidence for any reversibility to be expected. Thus, the test substance causes severe damages to the eyes, which in terms of classification according to Regulation (EC) No 1272/2008 implies classification as Eye Dam. 1 H318.
Executive summary:

A study for eye irritation in the rabbit was conducted with the test substance. The test substance (50 mg) was instilled into the conjunctival sac of one male and one female New Zealand White rabbit. Ocular reactions were scored at 1, 24, 48 and 72 h as well as 7 days after test substance administration. The Draize system was used for scoring eventual lesions. Cornea opacity (score 4) was noted in ½ of the whole region of the cornea at all reading points after administration in 1/2 animal. With regard to the second animal, cornea opacity (score 4) was observed in ¾ of the whole region while at 24, 48 and 72 h as well as at 7 days after administration the whole region of the cornea was affected (score 3). Iritis (score 1 – 2 in animal 1 and score 2 in animal 2) was observed in both animals at every observation. Redness of the conjunctivae was noted in both animals at 1, 24, 48, 72 h and 7 days (score 1 – 3). Swelling of the conjunctivae (score 1 – 3) was also noted through the whole observation period. Thus, under the conditions of this study, the test substance causes severe damages to the eyes, which in terms of classification according to Regulation (EC) No 1272/2008 implies classification as Eye Dam. 1, H318: Causes serious eye damage.