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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:
other: Study similar to guideline, but with restrictions (limited information on test substance, observation period only 72 hours).

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted 24 April 2002
Deviations:
yes
Remarks:
limited information on test substance, observation period only 72 h
Qualifier:
according to
Guideline:
other: U.S. Federal Register, 1973, Vol. 38, No. 187, Section 1500:42
Deviations:
no
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: in grid bottomed galvanised metal cages
- Diet: 90 - 95 g / day, Product Ref. 16934, Spillers Agriculture Limited
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Air changes: air conditioned room
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100 %
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Reading time points: 24, 48 and 72 h
Number of animals or in vitro replicates:
6 females
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.78
Max. score:
3
Reversibility:
not specified
Remarks:
observation only for 72 h, reversibility was not studied
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
24 h after exposure, chemosis was observed in 4 of 6 animals, which disappeared the next day. All 6 animals showed redness of the conjunctivae, which dissapeared in 3 animals the next day. At 72 h observation, redness was still observed in 2 animals. Since the observation was stopped after 72 h, there is no information on the reversibility of these effects in the remaining 2 animals.
Adverse effects on the cornea and the iris were not observed in any of the animals.

Any other information on results incl. tables

Table 1: Evaluation of the eye reaction

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

1 / f

24

0

0

2

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0.67

0

2 / f

24

0

0

2

1

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

0.33

3 / f

24

0

0

2

0

48

0

0

1

0

72

0

0

1

0

Mean (24, 48, 72 h)

0

0

1.33

0

4 / f

24

0

0

1

1

48

0

0

1

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0.67

0.33

5 / f

24

0

0

1

1

48

0

0

1

0

72

0

0

1

0

Mean (24, 48, 72 h)

0

0

1.0

0.33

6 / f

24

0

0

1

1

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

0.33

Group mean (24, 48, 72h)

0

0

0.78

0.22

 

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.