Butyronitrile

Eye irritation

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 was conducted pre-GLP and pre-guideline, so details in the report are lacking. However, the study was conducted at a highly reputable laboratory, and was done to the state of the art at the time.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1960

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

The study was conducted prior to OECD guidelines, but it follows the general layout of OECD 405.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyronitrile

EC Number:

203-700-6

EC Name:

Butyronitrile

Cas Number:

109-74-0

Molecular formula:

C4H7N

IUPAC Name:

butanenitrile

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

None given

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

1 drop

Duration of treatment / exposure:

14 days

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

1

Details on study design:

One drop of test article was applied to the eyes of a single rabbit followed by a 14-day observation period

Results and discussion

In vivo

Results

Irritation parameter:

other:

Time point:

other: 24 hours

Score:

> 0 - < 0

Reversibility:

not specified

Remarks on result:

other: No score was given but as TCC demands a value, dummy numbers were used.

Irritant / corrosive response data:

Eyes were held closed briefly. Slight erythema of conjunctiva. Normal at 1 hr and 24 hours, although there was slight staining of nictitating membrane with fluorescein. Normal at 14 days.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test article was minimally irritating.

Executive summary:

The test article was minimally irritating. Note that this study only used a qualitative grade. Numerical values were added as TCC required them, but such grades were not provided in the study.