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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
406-040-9
EC Name:
-
Cas Number:
125643-61-0
Molecular formula:
C24 H40 O3 C25 H42 O3 C26 H44 O3
IUPAC Name:
C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction: 1) intradermal induction, 1% in Sesamöl 2) epidermal induction, 30% in vaseline
Concentration of test material and vehicle used for each challenge: 1) 10% in Vaseline.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Vaseline
Concentration / amount:
Concentration of test material and vehicle used at induction: 1) intradermal induction, 1% in Sesamöl 2) epidermal induction, 30% in vaseline
Concentration of test material and vehicle used for each challenge: 1) 10% in Vaseline.
No. of animals per dose:
20 animals in test group.
10 animals in negative control group.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration did not cause irritating effects in preliminary studies.

Signs of irritation during induction: None were caused by the test substance.

Evidence of sensitisation of each challenge concentration: None

Other observations: none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information