Cyclopentane, methoxy-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 November 2002 - 24 December 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD test guidelines, and in compliance with GLP, and so the data is considered reliable without restriction.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-090-6

EC Name:

-

Cas Number:

5614-37-9

Molecular formula:

C6 H12 O

IUPAC Name:

Cyclopentyl methyl ether

Test material form:

liquid

Specific details on test material used for the study:

- Analytical purity: 99.9%
- Lot/batch No.: 020618

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 17.3 to 20.5 g
- Housing: Individually housed in polycarbonate cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 21 November 2002 To: 24 December 2002

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

Preliminary study : 50% (v/v) and 100% (dosed as supplied)
Main study: 25%, 50% (v/v) and 100% (dosed as supplied)
The main study also included a vehicle control group.

No. of animals per dose:

1 female per dose in the preliminary study
4 females per dose level in the main study

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: In a vehicle trial, NZE was found to form a miscible, clear colourless liquid at 50% (v/v) in Acetone : olive oil (4:1 v/v).

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Test substance is considered to be a sesitiser if at least one concentration tested results in a three-fold increase (relative to the concurrent vehicle control) in the incorporation of 3H-methyl Thymidine.

TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of each preparation was applied to the dorsal surface of the ear using a micropipette. The test substance was spread over the entire dorsal surface of the ear using the tip of the micropipette.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

Comments: Within this study the positive control hexyl cinnamic aldehyde was applied at 10, 25, 50% (v/v) preparations in (4:1 v/v acetone/olive oil). Stimulation indicies of >3 were obtained at all concentrations.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.2

Test group / Remarks:

25% v/v

Results 2

Parameter:

SI

Value:

1.3

Test group / Remarks:

50% v/v

Results 3

Parameter:

SI

Value:

2.6

Test group / Remarks:

100% v/v

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

None of the tested concentrations produced a test-control ratio greater than 3, so the substance is not regarded a potential sensitiser.