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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: summary data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Kodak footpad method
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
Study was conducted before the LLNA requirement was in place.

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexane-1,4-dicarboxylic acid
EC Number:
214-068-6
EC Name:
Cyclohexane-1,4-dicarboxylic acid
Cas Number:
1076-97-7
Molecular formula:
C8H12O4
IUPAC Name:
cyclohexane-1,4-dicarboxylic acid
Details on test material:
0.05 mL of a 1.0% solution in Freund's Complete Adjuvant

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Challenge
Route:
intradermal
No. of animals per dose:
10
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Group:
other: Freund's only
Dose level:
0.1 % in acetone/dioxane/guinea pig fat (7:2:1)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals appeared normal
Remarks on result:
other: Reading: rechallenge. Group: other: Freund's only. Dose level: 0.1 % in acetone/dioxane/guinea pig fat (7:2:1). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: all animals appeared normal.
Reading:
rechallenge
Group:
other: 1% cpd. in Freund's
Dose level:
0.1% in acetone/dioxane/guinea pig fat (7:2:1)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals appeared normal
Remarks on result:
other: Reading: rechallenge. Group: other: 1% cpd. in Freund's. Dose level: 0.1% in acetone/dioxane/guinea pig fat (7:2:1). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: all animals appeared normal.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged
Executive summary:

The test compound has a low potential for causing human sensitizaiton. No reaction was noted in either the induced or control groups when challenged