Butanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation, but sufficient for assessment.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Observations post-exposure only until day 7

GLP compliance:

no

Remarks:

Study pre-dates GCP requirements.

Test material

Test material information

Constituent 1

Reference substance name:

Butanone

EC Number:

201-159-0

EC Name:

Butanone

Cas Number:

78-93-3

Molecular formula:

C4H8O

IUPAC Name:

butan-2-one

Details on test material:

- Name of test material (as cited in study report): methyl ethyl ketone, Code N.

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Not reported.
- Weight at study initiation: At least 2.0 kg each.
- Housing: Housed singly and free of any extraneous materials which might cause irritation.
- Diet (e.g. ad libitum): Not reported.
- Water (e.g. ad libitum): Not reported.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL.

Duration of treatment / exposure:

Single exposure.

Observation period (in vivo):

up to 7 days.

Number of animals or in vitro replicates:

6 males.

Details on study design:

Twenty four hours prior to test, each eye was treated with 5% solution of sodium fluorescein dye for 20 seconds and then rinsed. 0.1mL of MEK was added to each eye (3 right eyes and 3 left eyes), holding shut the eye. Eyes were not rinsed, and were examined for lesions at 1, 24, and 72 hours post exposure, and again at 7 days. Scoring was done according to Draize 1944 (see attached File 1).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

19.2

Max. score:

110

Reversibility:

other:

Remarks:

The results from most laboratories show much lower overall irritation scores at 7 days

Remarks on result:

positive indication of irritation

Remarks:

Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

10.8

Max. score:

110

Reversibility:

other:

Remarks:

The results from most laboratories show much lower overall irritation scores at 7 days

Remarks on result:

positive indication of irritation

Remarks:

Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0.8

Max. score:

110

Reversibility:

other: as the mean response had recovered to close to zero by day 7, it can be surmised that the reactions would have likely reversed by day 14

Remarks on result:

no indication of irritation

Remarks:

Interlaboratory median value presented. Individual animal data were presented for each laboratory. Individual cornea, iris, conjunctivae and chemosis data were not presented, and data for the 48 hour time point were not given, however the substance is classified in Annex VI (Part 3) of the CLP regulation as a Category 2 eye irritant, therefore the study is acceptable for assessment.

Irritant / corrosive response data:

There was no reported evidence of corrosivity, and MEK had the least variation across laboratories compared with 8 other materials.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria