Cyclopentane, methoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 2002 - 04 March 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EC, OECD and US EPA test guidelines and in compliance with GLP; on this basis the study is considered reliable without restriction.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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: 99.8%
- Lot/batch No.: 010912

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: At least 11 weeks
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: Housed individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 12 February 2002 To: 04 March 2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 0.5 mL

Duration of treatment / exposure:

First animal - 3 minutes, 60 minutes, and 4 hours (three treatment sites)
Second and third animals - 4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 x 25 mm
- Type of wrap if used: Gauze pad held in place using an elasticated adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm (32 - 34°C) water At the end of the exposure period (4 minutes, 60 minutes, or 4 hours)
- Time after start of exposure:

SCORING SYSTEM:
Refer to tables under "Any other information on materials and methods incl. tables".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 12 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 12 days

Irritant / corrosive response data:

Well-defined to moderate to severe erythema with very slight to slight oedema was seen in all animals following the four hour exposure. Dermal reactions gradually ameliorated, resolving completely in one animal by Day 14, however, very slight erythema with or without very slight oedema was still evident in the two remaining animals at study termination on Day 14. Thickening of the skin was observed in all animals from Day 3 or 4, resolving in two animals by Day 12 or 14 but persisting in the remaining animal through to the final observation on Day 14. In addition, desquamation (characterised by dryness of the skin) was noted in one animal from Day 8 through 11 and in two further animals from Day 12 through to the final observation on Day 14. Also noted during the study were areas of ulceration on the edge of the dose site (thought to be caused by removal of the bandage) in two animals from Day 9 through 11 and cracking of the skin in one animal from Day 12 through 14.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The substance was concluded to have been irritating to skin following 4 hours' exposure.