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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:
1993-05-17 - 1993-06-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: BOR:WISW (SPF Cpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Harlan Winkelmann GmbH, 33176 Borchen, Gartenstr. 27

- Age at study initiation: 6 - 8 weeks

- Weight at study initiation: 131-180 g

- Fasting period before study: 16 hours before commencement of study.

-Housing: Conventional, maximum of 5 animals/cage

- Diet: Ssniff R 10 Comprehensive diet for rats (ad libitum)

- Water: ad libitum

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20°C ± 3°C

- Humidity (%): 30-70%

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: Not stated

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.85 cm3/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/group (2 of each sex in preliminary study and 3 of each sex in actual study. The final results include all animals.)
Control animals:
not specified
Details on study design:
A group of ten (5 male and 5 female) rats was given a single oral dose of undiluted test substance at a dose level of 2000 mg/kg bw. Animals were observed 1 and 4 hours after dosing and then once a day for 14 days. Bodyweights were recorded on the day of treatment and on days 7 and 14. All animals were subject to gross necropsy examination for any macroscopic abnormalities.
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities in response to the exposure.
Clinical signs:
Up to six hours after administration clinical signs of toxicity were noted including abnormal gait, squatting, staggering, salivation and lacrimation, hypothermia, and uncontrolled movements. All animals appeared normal by the 24 hour observation point.
Body weight:
Weight gain of ca. 40-80 g between day 0 and day 14 was evident in all animals.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 (rat) >2000 mg/kg was determined in a reliable study conducted in accordance with the now deleted OECD 401 test guideline and in compliance with GLP.