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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:
20 April 1998 and 11 May 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Lot/batch No.: 6090

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD strain (Crl:CD BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males: 203-223g; females: 200 - 222g
- Fasting period before study: overnight fasted
- Housing: in groups of up to 5 animals by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Ad libitum for the exception of app. 3-4 hours after dosing where no food was provided
- Water (e.g. ad libitum): Ad libitum for the exception of app. 3-4 hours after dosing where no water was provided
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 ºC
- Humidity (%): 52-61%
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Arachis oil BP
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg body weight
- Amount of vehicle (if gavage): 10 ml/kg



No. of animals per sex per dose:
Preliminary sighting study: 2
Main study: 5
Control animals:
no
Details on study design:
Preliminary sighting study:
A preliminary study was initially performed by oral administration of the test material to a pair of fasted animals (one male, one female) at a dose level of 500 mg/kg bw. No deaths or signs of toxicity were observed and a further pair of animals were treated at 2000 mg/kg bw. The dose level of the main study was derived from the results of this study and was the highest of the fixed dose levels which did not produce compound related mortality.

Main study:
The main study was performed by treatment of a group of five fasted males and five females at a dose of 2000 mg/kg bw. The test material was administered orally as a suspension in arachis oil BP. The animals were observed 0.5, 1, 2 and 4 hours after dosing, and then once daily for 14 days. Overt signs of clinical toxicity were recorded on day 0 and on days 1, 2, 3, 7 and 14. On day 14 all animals were killed by cervical dislocation and were subjected to gross necropsy.

Results and discussion

Preliminary study:
Species/strain: rat, Sprague-Dawley
2000 mg/kg bw: Evident toxicity: N; Mortality: N
500 mg/kg bw: Evident toxicity: N; Mortality: N
Observations: No deaths or signs of toxicity were observed at 500 and 2000 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed
Clinical signs:
No clinical signs of toxicity were noted during the study.
Body weight:
All animals showed expected gains in bodyweight over the 14-day study period.
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:
The acute oral LD50 of the test substance, in the Sprague-DawleyCD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test substance was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EU labelling regulations. No symbol or risk phrase are required.