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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with OECD GLP (1997) regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
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): Perfluorpropylvinylether
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 98.1%
- Purity test date: No data
- Lot/batch No.: 10B1001
- Expiration date of the lot/batch: January 14, 2001
- Stability under test conditions: Guranteed for 4 hours
- Storage condition of test material: In darkness at approximately 20C in a fume cupboard under under inert conditions (N2)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation: 6-10 weeks
- Weight at study initiation: Male Mean: 191 g, Female Mean: 188 g
- Fasting period before study: 16 hours
- Housing: Group housed (5/sex/cage) in macrolon type 4 cages with soft wood granulate in the cages.
- Diet (e.g. ad libitum): Ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25 C
- Humidity (%): 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 March, 2000 To: 23 March, 2000

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% emulsion in deionized water (2000 mg/kg body weight)
- Amount of vehicle (if gavage): 10 mL/kg body weight dose volume
- Justification for choice of vehicle: Test article solubility

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
0 (control), 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
All animals survived to scheduled necropsy.
Clinical signs:
Squatting posture (9 of 10 animals, 9/10), drawn in flanks (2/10), irregular respiration (10/10), and swollen abdomen (6/10) were noted in animals from 1 hour to 8 hours post-dose. Drawn in flanks and irregular respiration were not present at 24 hours after dosing. Swollen abdomen persisted in males (1 to 4 of 5 animals) through Day 11 and in females (2/5) through Day 4. Squatting posture persisted in males (2/5) through Day 4 and was not present in females at 24 hours after dosing. All animals were normal on Day 12.
Body weight:
Body weight was not adversely affected by test article treatment.
Gross pathology:
No abnormal findings were observed in test article treated animals upon gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test article (liquid, batch 10B1001) was evaluated in male and female rats. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 401 (1987) and Directive 92/69/EEC, guideline B.1 (1992). The test article was emulsified at 20% in deionized water. Rats (5/sex) received 2000 mg/kg test article via a single oral gavage. Parameters evaluated: clinical observations (daily), body weights (weekly), and gross necropsy (termination). All animals were terminated 14 days post-dose. All animals survived. Squatting posture (9 of 10 animals, 9/10), drawn in flanks (2/10), irregular respiration (10/10), and swollen abdomen (6/10) were noted in animals from 1 hour to 8 hours post-dose. Drawn in flanks and irregular respiration were not present at 24 hours after dosing. Swollen abdomen persisted in males (1 to 4 of 5 animals) through Day 11 and in females (2/5) through Day 4. Squatting posture persisted in males (2/5) through Day 4 and was not present in females at 24 hours after dosing. All animals were normal on Day 12. There were no abnormalities in body weights or gross necropsy observations. Based on the results of this study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.