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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chlorobutan-2-one
EC Number:
223-834-9
EC Name:
3-chlorobutan-2-one
Cas Number:
4091-39-8
Molecular formula:
C4H7ClO
IUPAC Name:
3-chlorobutan-2-one
Constituent 2
Reference substance name:
3-Chloro-2-butanone
IUPAC Name:
3-Chloro-2-butanone
Test material form:
other: colourless liquid
Details on test material:
Purity: > 98% (GC)

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
3 male animals, approx. 4 months of age, 1.9 - 2.1 kg body weight

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL!patch and animal
Duration of treatment / exposure:
4 hours, single administration
Observation period:
After the 4-hour exposure period the patch was removed and the resulting
reactions were examined. Scores were taken 60 minutes, 24, 48 and 72 hours
after patch removal.
Number of animals:
3 male animals
Details on study design:
Approximately 24 hours before the test, the fur was removed by shaving from the
dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin.
Only animals with healthy intact skin were used.
A dose of 0.5 mL was applied to the test site (area: approx. 6 cm2
).
The test substance was applied to the test site and then covered with a gauze
patch. The patch was held in contact with the skin by means of a semi-occlusive
dressing (non-irritating tape) for the duration of the exposure period. The
surrounding untreated skin served as a control.
Exposure time was four hours. During the exposure the animals were kept in comfortable
restrainers.
No residual test substance had to be removed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0
Irritant / corrosive response data:
An erythema (grade 1) was noted in animals no. one and two 60 min, in animal
no. three 24 hours after patch removal. There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
3-Chloro-2-butanone was found to be non-irritating in an OECD 404 study (semi-occlusive).
Executive summary:

Under the present test conditions three rabbits were exposed for 4 hours to

0.5 mL 3-Chlorbutanon-2/patch and animal (semi-occlusive condition).

An erythema (grade 1) was noted in animal nos. one and two 60 min, in animal

no. three 24 hours after patch removal. There were no systemic intolerance reactions.

According to the EC-Commission directive 67/548/EEC and its subsequent amendments

on the approximation of the laws, regulations and administrative provision

relating to the classification, packaging and labelling of dangerous substances and

the results obtained under the present test conditions 3-Chlorbutanon-2 was

non irritating to skin, hence, no labelling is required.