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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Principles of method if other than guideline:
The method used to assess eye irritancy is a modification of that prescribed for the purposes of the United States Federal Hazardous Substances Labelling Act (Federal Register, 1964, 29, 13009).
In addition corneal damage is assessed objectively by measurement of corneal swelling (Burton, 1972, Food Cosm. Toxicol. 10, 209)
GLP compliance:
no
Remarks:
study pre-dates introduction of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Specific details on test material used for the study:
Substance tested: 2-methyldecanonitrile

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White rabbits weighing at least one kilogram and at least seven weeks old, bought from a commercial supplier are used in the rabbit eye irritation test. Usually 6 animals are used to test each experimental material.
The animals are kept before and after the test singly in cages, from which all hay, straw or similar potentially irritant material is excluded. They are given water and a commercially available pelleted diet ad libitum. All animals are in good health at start of testing.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 μl: 50% and 100% (in Tween 80)
Observation period (in vivo):
15 minutes and days 1,2 ,3 and 4 after treatment
Each day after application of the test material the corneal thickness is measured until there is no more swelling.
Number of animals or in vitro replicates:
4 animals used

Results and discussion

In vivo

Results
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
10 μL of undiluted 2-methyldecanonitrile caused a slight corneal lesion (healing by day 3) in one rabbit and had no corneal effect on the other treated. Both had very slight conjunctivitis present at only 15 minutes.
10 μL of 50% 2-methyldecanonitrile caused moderate corneal opacities in the two animals treated (the lesions were still present as grade 0.5 , on day 4 when the test ended). There was slight conjunctivitis in both rabbits. Discharge was slight in both rabbits., one rabbit had slight iritis.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
10 μL of undiluted 2-methyldecanonitrile caused a slight corneal lesion (healing by day 3) in one rabbit and had no corneal effect on the other treated. Both had very slight conjunctivitis present at only 15 minutes.
10 μL of 50% 2-methyldecanonitrile caused moderate corneal opacities in the two animals treated (the lesions were still present as grade 0.5 , on day 4 when the test ended). There was slight conjunctivitis in both rabbits. Discharge was slight in both rabbits.