Cyclopentane, methoxy-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 January 2002 - 30 September 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 103 - 130g
- Fasting period before study: Yes (overnight before dosing and for 4 hours after dosing)
- Housing: metal cages with wire mesh floors
- Diet (e.g. ad libitum): Adlibitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days.

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

IN-LIFE DATES: From: 11 February 2002 To:08 March 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% Aqueous methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 mg/mL or 200 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg chosen as the starting dose for compliance with the guidelines.

Doses:

Group 1: 2000 mg/kg (3 females)
Group 2: 200 mg/kg (3 females)
Group 3: 200 mg/kg (3 males)

No. of animals per sex per dose:

3 (see above)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recorded on day 1 prior to dosing, day 8, and day 15. Body weights were also recorded on death if applicable.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macropathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: Two females dosed at 2000 mg/kg died within six and a half- hours of dosing.

Clinical signs of reaction to treatment comprised of piloerection, seen in all rats at both dosages. These signs were accompanied in all females at 2000 mg/kg by salivation, abnormal gait, lethargy, reduced body temperature, prostration, shallow respiration and lacrimation with prominent eyes and hunched posture in one female at 2000 mg/kg. Among rats at 200 mg/kg signs include hunched posture in all males and one female and abnormal gait in all females and one male. Recovery of surviving rats, as judged by external appearance and behaviour, was complete by either Day 2 (all rats at 200 mg/kg) or Day 3 (female at 2000 mg/kg).

Body weight:

All surviving animals were considered to have achieved satisfactory bodyweight gains throughout the study.

Gross pathology:

Macroscopic examination of both decedents revealed congestion (characterised by blood vessels injected) in the brain and thickened tissues and atrophy of the heart. Congestion and fluid contents were noted in the stomach and along the alimentary tract.

Effects on organs: No abnormalities were revealed for the remaining surviving animals at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute median lethal oral dose (LD50) to rats of the substance was demonstrated to be between 200 and 2000 mg/kg bodyweight.