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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
A new protocol and criteria for quantitative determination of sensitization potencies of chemicals by guinea pig maximization test.
Author:
Nakamura A, Momma J, Sekiguchi H, Noda T, Yamano T, Kaniwa M-A, Kojima S, Tsuda M,
Kurokawa Y
Year:
1994
Bibliographic source:
Contact Dermatitis 31: 72-85, 1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitization effect Acetone in guinea pig by guinea pig maximization test.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetone
Cas Number:
67-64-1
Molecular formula:
C3H6O
IUPAC Name:
Acetone
Specific details on test material used for the study:
- Name of test material (as cited in study report): Acetone
- Molecular formula: C3H6O
- Molecular weight: 58.0794 g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Challenge
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
48 hour
No. of animals per dose:
10 animals
Details on study design:
A. INDUCTION EXPOSURE
Induction was performed by intradermal injection and topical application of 100 % acetone according to the protocol of Magnusson and Kligman (no further details available)

B. CHALLENGE EXPOSURE
Challenge was performed 21 days after the initial intradermal injection by topical open application of 0.1 ml 100 % acetone to the shaved area of the flank

C. EVALUATION
48 hrs after the challenge application skin reactions were avaluated according to a modified scale for scoring:
erythema formation: grades from 0 to 4
edema formation: grades from 0 to 3
possible total maximum: 7
sensitization rate: number of animals with positve reaction/number of tested animals
mean response: [sum from all animals of (erythema score + edema score)] : numer of tested animals.
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Study design: in vivo (LLNA)

Statistics:
Mean response (MR)= Summation of numerical scoring / total number of animal

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No sensitization effect were observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Mean response (MR)= 0

No sensitization observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Skin sensitization study for Acetone was conducted on female Hartley guinea pigs by guinea pig Maximization test. No indications of a sensitizing potential of acetone were observed in a guinea pig maximization test.
Executive summary:

Skin sensitization study for Acetone was conducted on female Hartley guinea pigs by guinea pig Maximization test. A group of 10 female Hartley guinea pigs were used for the skin sensitization test (protocol of Magnusson and Kligman with modified scale for Scoring of skin responses). Induction was performed by intradermal injection and topical application of 100 %acetone. 21 days later the animals were challenged by topical application of 100 μl acetone on the shavedflank of 10 animals. No positive skin sensitization effect was observed in any animal. Therefore Acetone was considered to be non skin sensitizing in female Hartley guinea pigs.