1,1,2,2,3,3,4-heptafluorocyclopentane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1997-07-17 to 1997-07-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

OJ No. L383A, 29.12.92

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-710-1

EC Name:

-

Cas Number:

15290-77-4

Molecular formula:

C5H3F7

IUPAC Name:

1,1,2,2,3,3,4-heptafluorocyclopentane

Specific details on test material used for the study:

Batch No.: 9706-1A
Purity: 98.65

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: selected from a stock supply of healthy male and female CD rats of Sprague-Dawley origin (Hsd: Sprague-Dawley(CD)) which were obtained from Harlan UK Ltd, Bicester, Oxon, England.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: four to seven weeks
- Weight at study initiation: 92 to 115 g
- Fasting period before study: overnight
- Housing: housed in groups of up to five rats of the same sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (SpeciaI Diet Services RMl(E) SQC expanded pelIet), ad libitum
- Water: ad libitum
- Acclimation period: seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 245-6330-70
- Air changes (per hr): > 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was administered as supplied, at a dose volume of 1.226 mL/kg bodyweight.

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5 Males
5 Females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, All animals were killed on Day 15 by carbon dioxide asphyxiation. All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.
- Examinations performed:
- Mortality: Cages of rats were checked at least twice daily for any mortalities.
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
- Bodyweight: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Males: 0/5
Females: 0/5

Clinical signs:

Piloerection was observed in all rats within 22 minutes of dosing. There were no other clinical signs and recovery was complete in all animals by Day 2.

Body weight:

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

Gross pathology:

No macro-pathological abnormality revealed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 of the test substance in rats is > 2,000 mg/kg bw.

Executive summary:

This study was performed to assess the acute oral toxicity of test item to the rat based on EC method B.1.

A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, as supplied, administered at a dose level of 2000 mg/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths. Clinical signs of reaction to treatment were confined to piloerection seen in all rats, recovery was complete by Day 2.

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

No abnormalities were revealed at the macroscopic examination of animals killed at study termination on Day 15.

The acute lethal oral dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.