Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
1-methylcyclohexane-1-carbonyl chloride
EC Number:
608-291-1
Cas Number:
2890-61-1
Molecular formula:
C8H13ClO
IUPAC Name:
1-methylcyclohexane-1-carbonyl chloride

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Intradermal induction: 0.1% (= 0.4 mg test item/animal) in liquid paraffin.
Topical induction: 10% (= 50 mg test item /animal) in liquid paraffin.
Challenge: 0.1 % (= 0.5 mg test item/animal) in liquid paraffin.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
paraffin oil
Concentration / amount:
Intradermal induction: 0.1% (= 0.4 mg test item/animal) in liquid paraffin.
Topical induction: 10% (= 50 mg test item /animal) in liquid paraffin.
Challenge: 0.1 % (= 0.5 mg test item/animal) in liquid paraffin.
No. of animals per dose:
test group: 10,
control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
skin effects (grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: skin effects (grade 1).
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
skin effects (grade 1)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: skin effects (grade 1).
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore thus exhibits no skin-sensitization potential.