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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No further details.
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
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
Positive control results:
Not applicable.
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

p-tert-butylbenzaldehyde was shown to be a moderate skin sensitiser in the intradermal Freund's complete adjuvant test in guinea pigs. However it should be noted that the substance was not sensitising in the open epicutaneous test in guinea pigs conducted at the same laboratory.


Migrated from Short description of key information:
p-tert-butylbenzaldehyde was shown to be a skin sensitiser in the intradermal Freund's complete adjuvant test; a negative results is obtained in an open epicutaneous test performed by the same authors.

Justification for selection of skin sensitisation endpoint:
Older proprietary study conducted prior to guideline development, however the results indicate that the substance has skin sensitising properties. Another study performed to a different method does not indicate any sensitisation potential.

Justification for classification or non-classification

On the basis of the positive results observed in the FCA study, p-tert-butylbenzaldehyde should be classified as a skin sensitiser according to Regulation (EC) No 1272/2008.