Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 90.5 %
- colourless liquid
- The test substance was initially stored at -20°C and protected from light.
- The test substance was stored at +4°C until the treatment.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMAL
- Source: Iffa Credo (69210 L'Arbresle, France)
- Age: 6 weeks
- Weight at study initiation: 174 ± 9 g (males) and 150 ± 3 g (females)
- Upon their arrival at the laboratory, the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily.
- Animals were individually identified by earmarks or earnotches
- Diet: ad libitum
- Food: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- The animals were housed in groups of 4 to 7 animals of the same sex during the acclimatization period and groups of 5 animals of the same sex during the study.
- The day before treatment, the animals were fasted for a period of approximately 18 hours before administration of the test substance. They were then given food 4 hours after treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: none
Details on oral exposure:
- Volume administered: taking into consideration the specific gravity of the test substance (0.96)
- Post dose observation period: 14 days
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Clinical signs: examined at least once a day
- Mortality: recorded at least twice a day
- Body weight: measured just before administration then on days 5, 8 and 15.
- Necropsy: . macroscopic examination of the main organs: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities.
- Microscopic examination: no
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
The body weight gain was normal.
Other findings:
NECROPSY FINDINGS: No apparent abnormalities.
Due to the absence of macroscopic lesions, no organ samples were taken and no histological examination was performed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the experimental conditions, the LD0 of the test substance administered by oral route in rats was higher than 2000 mg/kg. No signs of toxicity were observed at this dose level.
Executive summary:

The test substance was administered by oral route to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females) in an acute toxicity test by oral route (OECD 401, GLP).

The test substance was administered in its original form at a dose level of 2000 mg/kg at a volume taking into consideration that the specific gravity of the test substance was .96.

The mortality, general behaviour and body weight gain of the animals were observed for a period of 14 days after the single administration of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.

The general behaviour and body weight gain of the animals were not influenced by the treatment. No deaths occurred at the dose level of 2000 mg/kg. The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.