Acetone

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets basic scientific principles; open epicutaneous exposure to the volatile test substance is expected to reduce the actual dermal uptake; study sufficiently documented, acceptable for assessment

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

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Guinea pig maximization test (Magnusson and Kligman, 1969) with modified scoring scale: determination of background sensitization rate as acetone is used as vehicle for other substances

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Existing study, performed before LLNA was available as OECD guideline

Test material

Test material information

Constituent 1

Reference substance name:

Acetone

EC Number:

200-662-2

EC Name:

Acetone

Cas Number:

67-64-1

Molecular formula:

C3H6O

IUPAC Name:

propan-2-one

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

100 %

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

100 %

No. of animals per dose:

10

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:

other substances tested, e.g. 2-mercaptobenzothiazole

Results and discussion

Positive control results:

Positve responses were found with 2-mercaptobenzothiazole with a sensitization rate of 5/5 and mean responses uo to 5.0 (depending on induction and challlenge concentrations)

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

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Sensitization rate 0/10; mean response 0

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

No indications of a sensitizing potential of acetone were found in a guinea pig maximization test.

Executive summary:

Acetone, used as vehicle for other test substances, was tested in a guinea pig maximization test (protocol of Magnusson and Kligman with modified scale for scoring of skin responses) with a group of 10 female Hartley guinea pigs. 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 shaved flank. No positive skin response was found in any of the animals.