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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: insufficient documentation, scientifically not acceptable, assessed by OECD SIDS

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Immediate Generalized Skin Reactions in Hypersensitive Guinea Pigs.
Author:
Jacobs JL
Year:
1940
Bibliographic source:
Proc Soc Exptl Biol Med 43: 641
Reference Type:
secondary source
Title:
Acetic Anhydride
Author:
OECD SIDS
Year:
1997
Bibliographic source:
SIDS Initial Assessment Report for 6th SIAM (Paris, 9-11 June 1997)

Materials and methods

Principles of method if other than guideline:
Guinea pigs were given twice weekly intracutaneous injections of 0.05 ml of a solution in olive oil for 2-2.5 weeks. A 25% solution was applied dermally and the skin was “scratched through the solution” and examined.
GLP compliance:
no
Type of study:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetic anhydride
EC Number:
203-564-8
EC Name:
Acetic anhydride
Cas Number:
108-24-7
Molecular formula:
C4H6O3
IUPAC Name:
acetyl acetate
Details on test material:
- Name of test material (as cited in study report): Acetic anhydride

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
olive oil
Concentration / amount:
Induction: 0.05 ml of a solution in olive oil,
Challenge: 25% solution
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
olive oil
Concentration / amount:
Induction: 0.05 ml of a solution in olive oil,
Challenge: 25% solution
No. of animals per dose:
no data
Details on study design:
1st application: Induction 0.05 mL intracutaneous
2nd application: Induction 0.05 mL intracutaneous
3rd application: Challenge 25 %, "scratched through the solution"

Results and discussion

Any other information on results incl. tables

A local response claimed to be indicative of a sensitization reaction was produced when, not more than 2 weeks after the induction regime, a 25% solution was applied dermally and the skin was "scratched through the solution" and examined. Number of animals with skin reaction at challenge not specified. Number of animals with skin reaction in control group at challenge not specified.

Applicant's summary and conclusion