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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No details on test substance, test animals and environmental conditions.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no details on test substance, test animals and environmental conditions.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Remarks:
paste
Details on test material:
- Description: White pasty product
- Date of receipt: 10 September 1980
Specific details on test material used for the study:
Test substance was tested pure and undiluted

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: Animals were caged individually.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Concentration: Undiluted
Duration of treatment / exposure:
Eyes were not washed following instillation of test substance.
Observation period (in vivo):
24 and 72 h after the application of the test substance
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Skin reactions were evaluated by the method of Draize.

TOOL USED TO ASSESS SCORE: Ocular reactions were read using a binocular magnifying glass.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
5 animals (# 2,3,4,5,6)
Time point:
24/48 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
5 animals (# 2,3,4,5,6)
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Test substance caused slight conjunctivitis in one out of six rabbits. After 48 hours these lesions had cleared up.
Other effects:
None

Any other information on results incl. tables

Table 7.3.2/1: Individual and average ocular lesion scores

Rabbit No.

Cornea

Iris

Conjunctivae

redness

Chemosis

24 hours

13

0

0

1

1

14

0

0

0

0

15

0

0

0

0

16

0

0

0

0

17

0

0

0

0

18

0

0

0

0

48 hours

13

0

0

0

0

14

0

0

0

0

15

0

0

0

0

16

0

0

0

0

17

0

0

0

0

18

0

0

0

0

Mean (24 and 48 h)

0

0

0.08

0.08

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not classified as irritant to the eyes according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study, undiluted test substance was instilled into one eye of 6 New Zealand White rabbits while the untreated eye served as control. The eyes were not rinsed after the instillation of test substance. Animals were observed at 24 and 48 h after instillation of test substance into eyes. The reactions in the conjunctivae (redness and chemosis), the iris and the cornea were scored according to the Draize scale.

Test substance caused slight conjunctivitis in one out of six rabbits. The observed conjunctival reactions were disappeared completely within 48 hours. The calculated mean score for 6 animals (24 and 48 h) were 0.08 for redness, 0.08 for chemosis, 0.0 for iris lesions and 0.0 for corneal opacity.

Under the test conditions, the test substance is not classified as irritant to the eyes according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.