Registration Dossier

Diss Factsheets

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
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

Constituent 1
Chemical structure
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:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
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.

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