Ammonium difluoro[1,1,2,2-tetrafluoro-2-(pentafluoroethoxy)ethoxy]acetate

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

SafePharm Laboratories, Derbyshire, UK

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): EEA-NH4
- Chemical name: ammonium perfluoro-3,6-dioxaoctanate
- Physical state: white solid
- Lot/batch No.: RS4-56
- Storage condition of test material: approximately 4 °C 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
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: the bodyweights fell within an interval of ±20% of the mean initial bodyweight of the first treated group
- 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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25ºC
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes
- Photoperiod (hrs dark / hrs light): 12 / 12 (06:00 tot 18:00 light)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml and 30 mg/ml
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not provided
- Lot/batch no. (if required): not applicable
- Purity: not applicable

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 and 300 mg/kg bw

No. of animals per sex per dose:

three animals per dose

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 or death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not performed

Results and discussion

Preliminary study:

None

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Mortality:

All animals treated at a dose level of 2000 mg/kg bw were found dead or killed in extremis. There were no deaths noted in animals treated at a dose level of 300 mg/kg bw.

Clinical signs:

Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg bw were hunched posture, ataxia, lethargy, decreased respiratory rate, noisy respiration, dehydration and diuresis. There were no signs of toxicity noted in animals treated at a concentration of 300 mg/kg bw.

Body weight:

The surviving animals showed expected bodyweight gain over the study period.

Gross pathology:

Abnormalities noted at necropsy of animals treated at the dose level of 2000 mg/kg bw were abnormally red lungs, dark liver, dark kidneys and clear liquid present in the stomach. No abnormalities were noted in the animales treated at a dose level of 300 mg/kg bw.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information