Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-

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:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

EC Number:

700-684-7

Cas Number:

80793-17-5

Molecular formula:

C8H5F13

IUPAC Name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

Details on test material:

- Name of test material (as cited in study report): 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane
- Physical state: clear colourless liquid
- Batch number: #050825-7
- Storage condition of test material: approximately 4ºC in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 201-218 g
- Fasting period before study: overnight fast and three to four hours after dosing
- Housing: groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK (ad libitum)
- Water: mains drinking water (ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.29 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations 0.5, 1, 2 and 4 hours after dosing and subsequently once daily up to 14 days; weighing prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be > 2500 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat in accordance with OECD Guideline 423 (Acute Oral toxicity – Acute Toxic Class Method). Six fasted females (3 females/group) were administered the undiluted test material orally at a dose level of 2000 mg/kg bodyweight. All animals showed expected bodyweight gains, and no signs of systemic toxicity, deaths, or abnormalities at necropsy were observed. The acute median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be > 2500 mg/kg bodyweight.