Pentan-3-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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: Study meets scientific standards with acceptable restrictions.

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

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.81-2.84 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL

Duration of treatment / exposure:

Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h

Observation period:

Experiment 1: up to 8 days
Experiment 2: up to 8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: An application site of 2.5 x 2.5 cm was covered with the liquid (37°C; approx. 1 ml)

REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.

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:

erythema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

other: 24-48-72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

other: 24-48-72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 6 d

Remarks on result:

other: scaling observed until d 8

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

other: 24-48-72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 3 d

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

other: 24-48-72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2d

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

other: 24-48-72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 d

Remarks on result:

other: scaling observed until d 8

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Exposition:	20 h
Animal	Reading	Erythema	Edema	Comment
1	24 h	2	0
2	24 h	3	2	laminar (erythema)
1	48 h	1	0
2	48 h	3	2	laminar on one border (erythema)
1	72 h	1	0
2	72 h	1	0	pergament-like
1	6 d	0	0
2	6 d	0	0	scaling
1	8 d	0	0
2	8 d	0	0	scaling
mean	24 - 72 h	1.83	0.67
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	1	0
2	24 h	2	0
1	48 h	0	0
2	48 h	2	0
1	72 h	0	0
2	72 h	1	0
1	6 d	0	0
2	6 d	0	0	scaling
1	8 d	0	0
2	8 d	0	0	scaling
mean	24 - 72 h	1.00	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

In a dermal irritation study (BASF AG, Department of Toxicology, 1969) two Vienna White rabbits were dermally exposed to undiluted Diethylketone. The test site (intact dorsal skin) was covered with an occlusive dressing for 1, 5 , 15 minutes or 20 hours, respectively. Rabbits were observed for 7 -8 days. Irritations regarding erythema, edema and necrosis were scored and converted into the presently used numerical grading system according to OECD test guideline 404. The mean value of the scores for either erythema or edema formation at the 24, 48 and 72 hour reading calculated overall the animals tested was 1.83 and 0.67, respectively, for the 20-h exposure period and 1.0 and 0.0, respectively, for the 15 min exposure period. These signs of irritation had resolved at the 6-day reading. Scaling was noted in one animal at the end of the observation period (day 8).