Pivaloyl chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

other

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pivaloyl chloride

EC Number:

221-921-6

EC Name:

Pivaloyl chloride

Cas Number:

3282-30-2

Molecular formula:

C5H9ClO

IUPAC Name:

2,2-dimethylpropanoyl chloride

Details on test material:

Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 99% on the MSDS.

Test animals / tissue source

Species:

rabbit

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Three of the nine treated eyes were each washed with room temperature deionized water 30 seconds after treatment.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

9 (eyes of 3 animals were washed after 30 s)

Details on study design:

A test with fluorescein showed that the eyes were normal prior to testing. Test material (0.1 ml) was placed into the conjunctival sac of the right eye of each of 9 animals. The lids were held together for one second. Three of the nine treated eyes were each washed with room temperature deionized water for 1 minute, 30 seconds after treatment.
The untreated left eye served as a control.

The treated eyes were examined for irritation 1, 24, 48 hours and 4, 7, 10, 14, 17 and 21 days after treatment. The corneas were re-examined after treatment with 0.2% fluorescein sodium ophthalmic solution after the 24 hour observation time. If staining was observed, staining was repeated after each subsequent evaluation time until staining no longer occurred.

Eyes were scored on scales of 0-4 for corneal opacity, area of cornea involved, fluorescein staining, corneal stippling, and conjunctival chemosis; a scale of 0-2 for iridial effects, scales of 0-3 for conjunctival redness and discharge, for total maximum corneal, iridial and conjunctival scores of 80, 10 and 20 (total maximum of 110).

Results and discussion

In vivo

Results

Irritation parameter:

other: maximum average score

Score:

39.8

Remarks on result:

other: moderately irritating

Remarks:

24 hours

Any other information on results incl. tables

A maximum average irritation score of 39.8 was obtained for nonwashed eyes 24 hours after treatment. The score for washed eyes at this time was 33.3. Positive staining occurred in all nonwashed eyes and 2 washed eyes at 24 hours. Staining resolved in nonwashed and washed eyes by Days 7 and 4, respectively.
One animal whose eyes were not washed died on day 11. This was not considered to be related to administration of the test material.