Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 December 2001 to 20 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

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:
other: EC method B.1 (1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Perfluormethoxypropylvinylether
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Purity test date: 30 July 2000
- Lot/batch no.: Lot 3
- Storage condition of test material: Darkness at 5 °C in a refrigerator under nitrogen atmosphere

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Minkelmann GmbH
Gartenstrasse 27
D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Males: 198-199 g, Females: 172-184 g
- Fasting period before study: No details other than "fasted"
- Housing: 3 animals per cage in transparent macrolon (type IV) cages
- Diet (e.g. ad libitum): Ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 04 December 2001 To: 20 December 2001

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight.
DOSAGE PREPARATION: The test article was administered undiluted.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose was chosen based on toxicicty data or related compounds.
Doses:
A single 2000 mg/kg bw dose was administered to the test group animals.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded twice a day, body weights were recorded on Days 1, 8, and 15.
- Necropsy of survivors performed: yes, macroscopic
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: A single 2000 mg/kg bw dose was administered by oral gavage.
Mortality:
No mortality occurred during the study.
Clinical signs:
On study Day 1, stilted gait was observed in 1 animal and a squatting posture in 2 animals. No other clinical signs were observed in any other animals at any time points.
Body weight:
Development of body weight was not impaired.
Gross pathology:
No macroscopically visible changes were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Based on the results of the study, the oral LD50 of the test substance is > 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity of the test article was determined in Sprague Dawley rats. The study was conducted in compliance with OECD GLP (1999). The test method was based on OECD Guideline 423 (1996) and EC Method B.1 (1996). Rats (3/sex) were administered a single dose of 2,000 mg/kg body weight of undiluted test article by oral gavage. Body weights (Days 1, 8, and 15) and clinical signs (twice daily) were recorded. No mortality occurred during the study, and body weight gain was not impaired. On study Day 1, stilted gait was observed in 1 animal and a squatting posture in 2 animals. No other clinical signs were observed in any other animals at any time points. Based on the results of the study, the oral LD50 of the test article is > 2000 mg/kg body weight.