Cyclopentane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study adhered to the principles outlines in OECD 423 guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Only summary information was provided. Key study information (purity, stability, characterization, and verification of the test material; strain, selection, diet, and housing of animals) was not provided.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentane

EC Number:

206-016-6

EC Name:

Cyclopentane

Cas Number:

287-92-3

Molecular formula:

C5H10

IUPAC Name:

cyclopentane

Details on test material:

- Name of test material (as cited in study report): cyclopentane
- Substance type: C5 aliphatics

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not reported

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none provided

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily and weighedat study initiation, on day 7, and on day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

none

Results and discussion

Preliminary study:

not reported

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No animals died over the 14 days of observation.

Clinical signs:

other: Clinical signs observed over the first 24 hours after exposure included depression (sometimes slight), red stains on the nose and/or eyes, rough coat, soft feces, a hunched appearance, and urine stains. All animals appeared normal from day 2 until study

Gross pathology:

There were no gross abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for cyclopentane is greater than 5000 mg/kg.

Executive summary:

In an acute oral toxicity study, cyclopentane was administered orally as a single 5000 mg/kg dose to male and female rats. Specifics of the treatment and vehicle were not provided. Animals were observed for 14 days, then a gross necropsy was performed. In the first 24 hours, rats exhibited depression or slight depression, red stains on the nose and/or eyes, rough coat, soft feces, hunched appearance, and urine stains. All animals were normal by day 2. No mortalities occurred during treatment or throughout the 14 -day observation period. There were no treatment-related changes in body weight or gross pathology. Based on the results, the oral LD50 of cyclopentane in male and female rats is greater than 5000 mg/kg.

This study received a Kilmisch score of 2 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study adhered to the principles outlines in OECD 423 guidelines.