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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: see 'Remark'
Remarks:
Study performed before test guidelines and GLP principles were in place. However missing information and shortcomings in description of the methods. No details on test substance (Lot/Batch number; purity). Exact dosing of test substance not clearly described.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: tests published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963)
Qualifier:
according to
Guideline:
other: Draize and Kelley (Drug Cosmet. Industr, 71 (1952) 36
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
substance was applied 50% diluted, probably due to the fact that the test substance is a waxy substance and could not be applied in the eye as such; it is unclear whether 0.1 ml of succinonitrile or 50% succinonitrile/ 50% water was tested.
GLP compliance:
no
Remarks:
Study performed before GLP principles were in force

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details given.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Housing: individually housed
Rabbits received no hay or other extraneous material that might enter the eyes

Test system

Vehicle:
water
Remarks:
50%
Controls:
other: untreated eye serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: 50%

Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Eyes were examined at 24, 48, 72 hours and 7 days after instillation
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
Draize scoring according to current OECD/EC guidelines

TOOL USED TO ASSESS SCORE:
binocular magnifying glass, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours after instillation
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours after instillation
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Remarks:
redness
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours after instillation
Score:
ca. 0.07
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
chemosis
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corrosive effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An eye irritation test similar to the current OECD guideline was performed with rabbits. The substance was applied 50% diluted and gave minor, reversible effects.
Based on these results this substance is not classified for eye irritation.
Executive summary:

An eye irritation test similar to the current OECD guideline was performed with 6 rabbits. The suspension of succinonitrile in water (50%) caused slight redness of the conjunctivae in two out of six rabbits. These effects were reversible within 7 days. Based on these results this substance is not classified for eye irritation.