(S,S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane;reaction mass of: (R,R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: US EPA Pesticide Assessment Guidelines Subdivision F, 81-1

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

GLP compliance:

yes

Test type:

other: acute oral toxicity

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-640-8

EC Name:

-

Cas Number:

138495-42-8

Molecular formula:

C5H2F10

IUPAC Name:

(3R,4R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane; (3S,4S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Details on test material:

- Purity: 99.9%

Test animals

Species:

rat

Strain:

other: Crl:CD®BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 57 days (male rats); 64 days (female rats)
- Weight at study initiation: 212.1-229.4 g (male fasted weight); 184.5-197.6 g (female fasted weight)
- Fasting period before study: approximately 18 hours
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): ad libitum, except for approximately 18 hours prior to 3 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: approximately 3.16 mL/kg body weight

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 male and 5 female per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily throughout the study. Rats were observed daily (weekends excluded) for clinical signs of toxicity.
-Frequency of weighing: Rats were weighed daily (weekends excluded).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No adverse effects observed. No clinical signs of toxicity and no gross lesions observed.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No gross lesions were present.

Applicant's summary and conclusion

Interpretation of results:

other: very low toxicity

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

LD50 >5000 mg/kg

Executive summary:

Single doses of the test substance were administered by intragastric intubation to fasted male and female rats at a dosage of 5000 mg/kg of body weight. The rats were observed for clinical signs of toxicity and mortality over a 14-day observation period. No deaths occurred during the study. Intermittent weight losses of up to approximately 6% of previously measured body weight were observed in some female animals during the study. No clinical signs of toxicity were observed. No gross lesions were observed in study rats at necropsy. Under the conditions of this test, the oral LD₅₀ for the test substance was >5000 mg/kg.