Cyclopentane, methoxy-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 November 2002 - 01 April 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EC and OECD test guidelines, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

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: 99.99%
- Lot/batch No.: 020618

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 to 12 weeks.
- Weight at study initiation: 213 to 267g.
- Housing: Housed individually in metal cages until day 9, when the rats were returned to group housing.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum access to drinking water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours artificial light / 12 hours darkness.

IN-LIFE DATES: From: 11 November 2002 To: 27 November 2002

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 50mm x 50mm
- Type of wrap if used: Porous gauze held in place with a non-irritant dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes - washed with warm (30 - 40°C) water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.35 mL/kg bodyweight (specific gravity = 0.850 g/mL)
- Concentration (if solution): N/A - administered as supplied

Duration of exposure:

24 h

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 (5 males and 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed twice daily for clinical signs of toxicity, and daily for signs of a dermal response. Bodyweights were recorded on days 1 (prior to dosing), 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal responses, body weight, macroscopic pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: There was no systemic response to treatment in any animals throughout the study.

Body weight:

Low bodyweight gains were recorded for four females on day 8 and two females on day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.

Gross pathology:

Effects on organs: No abnormalities were noted in any animal.

Other findings:

Signs of toxicity (local): Very slight to well-defined dermal irritation with or without very slight oedema was observed in nine animals following removal of the dressings, resolving completely by Day 5. In addition, dryness/exfoliation was observed in nine animals and spots and/or scabbing (confined to small area of dose site) was observed in one animal, resoving completely by Day 9.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute lethal dermal dose to rats of the substance was demonstrated to ber greater than 2000 mg/kg bodyweight.