Pentan-3-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation; 50 μl instead of 100 μl test substance instilled )

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

50 μl instead of 100 μl test substance instilled

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentan-3-one

EC Number:

202-490-3

EC Name:

Pentan-3-one

Cas Number:

96-22-0

Molecular formula:

C5H10O

IUPAC Name:

pentan-3-one

Details on test material:

- Name of test material (as cited in study report): Diaethylenketon
- Physical state: liquid
- Analytical purity: 99.8%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2,17 - 2.67 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed


SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8, 7, or 5 days (animal #1, #2 or #3, respectively)

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 5, 7, or 5 days (animal #1, #2 or #3, respectively)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	24 h	1	0	1	1
2	24 h	1	0	1	1
3	24 h	1	0	1	1
1	48 h	1	0	1	0
2	48 h	1	0	1	0
3	48 h	1	0	1	0
1	5 d	1	0	0	0	reading after fluorescein application
2	5 d	1	0	1	0
3	5 d	0	0	0	0	reading after fluorescein application
1	7 d	1	0	0	0	reading after fluorescein application
2	7 d	0	0	0	0	reading after fluorescein application
3	7 d	0	0	0	0	reading after fluorescein application
1	8 d	0	0	0	0	reading after fluorescein application
mean	24 - 48 h	1.00	0.00	1.00	0.50

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Executive summary:

In a primary eye irritation study (BASF AG, Department of Toxicology, 1969), 50 µl of undiluted Diethyl ketone was instilled into the conjunctival sac of one eye of 3 White Vienna rabbits. The eyes were not washed out after 24 hours. Animals were observed for 8 days. After 24 hour, slight erythema, slight edema as well as slight corneal opacity were observed. Next observation was made after 48 hours after application. No observation was performed after 72 hours. The mean value of the scores at the 24- and 48-hour reading for erythema, edema, corneal opacity and chemosis calculated overall the animals tested was 1.0, 0.5, 1.0 and 0.0, respectively. The observed changes were fully reversible in all animals within 48 h (edema), 7 days (erythema), and 8 days (corneal opacity).