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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
May 5, 2006 - October 19, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Old study

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-4-oxo-3-(prop-2-en-1-yl)cyclopent-2-en-1-yl (1R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate
EC Number:
687-634-7
Cas Number:
231937-89-6
Molecular formula:
C19H26O3
IUPAC Name:
2-methyl-4-oxo-3-(prop-2-en-1-yl)cyclopent-2-en-1-yl (1R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
5% v/v
Day(s)/duration:
0
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Day(s)/duration:
7
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Day(s)/duration:
21
No. of animals per dose:
10 males and 10 females in treatment group
Challenge controls:
5 males and 5 females in control group
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

Positive control results:
positive response in 65% of animals at 24 hours, 50% of animals at 48 hours

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
none
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
none
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
not reported
No. with + reactions:
13
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
not reported
No. with + reactions:
10
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Visual observation of the skin following challenge exposure did not reveal any positive skin response at 24 and 48 hours post patch removal in the animals belonging to the treatment group.
Executive summary:

Guinea pigs were divided in two groups. 5% (v/v) test material in propylene glycol was selected for intradermal injection during induction exposure. Undiluted test material was selected for topical application during induction and challenge. The skin reactions were recorded post induction and post challenge treatment.