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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Exisitng in vivo study available (1974)

Test material

Constituent 1
Chemical structure
Reference substance name:
[1R-(1α,2β,5α)]-2-isopropyl-5-methylcyclohexyl 5-oxo-L-prolinate
EC Number:
264-935-8
EC Name:
[1R-(1α,2β,5α)]-2-isopropyl-5-methylcyclohexyl 5-oxo-L-prolinate
Cas Number:
64519-44-4
Molecular formula:
C15H25NO3
IUPAC Name:
[1R-(1α,2β,5α)]-2-isopropyl-5-methylcyclohexyl 5-oxo-L-prolinate
Details on test material:
Sample N° 7560

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: 6% acetone/saline
Concentration / amount:
0.1875%
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
other: 6%acetone/ saline
Concentration / amount:
0.075%
No.:
#2
Route:
other: topical
Vehicle:
other: acetone
Concentration / amount:
20%
No. of animals per dose:
10
Details on study design:
Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.
Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
induction 0.1875%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Group:
test chemical
Dose level:
intradermal injection 0.075%/ topical application 20%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Reading:
rechallenge
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No guinea pigs sensitized after 1 or 2 induction-treatments.
Executive summary:

A Guinea pig skin sensitization test was conducted with the test item.

10 Guinea pigs were treated to induce sensitization by intradermal injection, and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization the induction and challenge sequences were repeated.

After 2 sets of sensitizing injections no guinea pigs were sensitized.