Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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 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