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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Maximization Test of Magnusson and Kligman
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
4,6-bis(octylthiomethyl)-o-cresol
EC Number:
402-860-6
EC Name:
4,6-bis(octylthiomethyl)-o-cresol
Cas Number:
110553-27-0
Molecular formula:
C25H44OS2
IUPAC Name:
4,6-bis(octylthiomethyl)-o-cresol

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Intradermal: sesame oil and adjuvant saline mixture. Epicutaneous: Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction: 1st induction (intradermal): 1% in sesame oil and adjuvant saline mixture.
2nd induction (epidermal): 30% in vaseline
Concentration of test material and vehicle used for each challenge: 3% in vaseline
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Intradermal: sesame oil and adjuvant saline mixture. Epicutaneous: Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction: 1st induction (intradermal): 1% in sesame oil and adjuvant saline mixture.
2nd induction (epidermal): 30% in vaseline
Concentration of test material and vehicle used for each challenge: 3% in vaseline
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
Not specified.
Challenge controls:
Not specified.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: Not specified..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Not specified..
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Not specified..
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Not specified..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Not specified..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Not specified..

Any other information on results incl. tables

Because all reactions observed in the standard challange were mild a 2nd challenge application was performed. In this 2nd test only 5% of the animals were judged to have been sensitized by the test compound which leads to the conclusion that the reactions observed in the first application were not specific. As it may happen in adjuvant treated animals the substance is not classified as sensitizer according to the Directive.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Because all reactions observed in the standard challange were mild a 2nd challenge application was performed. In this 2nd test only 5% of the animals were judged to have been sensitized by the test compound which leads to the conclusion that the reactions observed in the first application were not specific. As it may happen in adjuvant treated animals the substance is not classified as sensitizer according to the Directive
Executive summary:

Because all reactions observed in the standard challange were mild a 2nd challenge application was performed. In this 2nd test only 5% of the animals were judged to have been sensitized by the test compound which leads to the conclusion that the reactions observed in the first application were not specific. As it may happen in adjuvant treated animals the substance is not classified as a sensitizer.