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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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: Older proprietary study conducted prior to development of the guidelines, methodology not fully reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Intradermal FCA test in guinea pigs
GLP compliance:
no
Type of study:
Freund's complete adjuvant test

Test material

Constituent 1
Reference substance name:
tert-butylbenzaldehyde
IUPAC Name:
tert-butylbenzaldehyde
Test material form:
other: liquid
Details on test material:
The test material was p-tert-butylbenzaldehyde. No further details available.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No further details.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other:
Concentration / amount:
Induction: 5% emulsion in Freund's complete adjuvant (FCA)
Challenge: 0.1, 0.3, 1, 3 and 10% in ethanol
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other:
Concentration / amount:
Induction: 5% emulsion in Freund's complete adjuvant (FCA)
Challenge: 0.1, 0.3, 1, 3 and 10% in ethanol
No. of animals per dose:
6 animals per dose
Details on study design:
Induction: five intradermal injections of 0.1 ml of a 5% emulsion in FCA (0.05 ml FCA plus 0.05 ml test material) were made into the neck of the guinea pigs on Days 0, 2, 4, 7 and 9. Controls were treated with 0.05 ml FCA only.
Challenge: 0.025 ml was administered epicutaneously at 0.1, 0.3 and 1% on Day 35, or 3 and 10% on Day 21.
Challenge controls:
No information.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not applicable.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
10%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Group:
test chemical
Dose level:
3%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Group:
test chemical
Dose level:
1%
No. with + reactions:
6
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 1%. No with. + reactions: 6.0. Total no. in groups: 6.0.
Reading:
1st reading
Group:
test chemical
Dose level:
0.3%
No. with + reactions:
3
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.3%. No with. + reactions: 3.0. Total no. in groups: 6.0.
Reading:
1st reading
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 6.0.

Any other information on results incl. tables

Under the conditions of the study, the test material showed sensitising properties.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the test material showed sensitising properties.
Executive summary:

A study was conducted in groups of 6 guinea pigs to determine the skin sensitising potential of p-tert-butylbenzaldehyde. A 5% emulsion of the test material in Freund's complete adjuvant (FCA) was injected (0.1 ml) intradermally into the neck of the guinea pigs on days 0, 2, 4, 7 and 9. Controls received 0.05 ml FCA. Test animals were challenged with an epicutaneous dose of the test material (0.025 ml) on Days 21 and 35, the reactions were read after 48 and 72 hours. Doses at challenge were 10%, 3%, 1%, 0.3% or 0.1%. A 100% sensitisation rate was seen at 10, 3 and 1%, and 50% rate was seen at 0.3% and a 0% rate was seen at 0.1%. It was concluded that the test material shows sensitising properties and is a moderate intradermal sensitiser.