Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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
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
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).