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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
not indicated
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: ECHA communication on permission to refer - Inquiry number: 06-2120740615-56-0000
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
In vivo not-LLNA already available

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
EC Number:
407-520-0
EC Name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
Cas Number:
80657-64-3
Molecular formula:
C13H20O2
IUPAC Name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
Test material form:
liquid

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Alembicol D
Concentration / amount:
20% v/v
Day(s)/duration:
not specified
Route:
other: topical
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
not specified
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
not specified
No.:
#1
Route:
other: topical
Vehicle:
other: Alembicol D
Concentration / amount:
50%
Day(s)/duration:
not specified
No. of animals per dose:
20 for test group
10 for negative control
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Group:
positive control
Remarks on result:
other: positive control not tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met