Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study onducted under OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sponsors identification: SR-720
Description: White powder
Storage condition: ambient temperature (< 25 °C) stored under artificial light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female rats were supplied by Charles River, Margate, Kent, UK.
At the start of the main study the males weighed 218- 229g and the females 206-238g and were 8-12 weeks of age.
After acclimatisation period of at least five days the animals were selected at random and given a number by indelible ink-marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in a solid-floor polypropylene cages furnished with woodflakes.
Free access to drinking water and food (Rat and Mouse Expanded Diet No. 1, Special diets Services Limited, Witham, Essex UK), except for overnight fast immediately before dosing and for approx. 3-4 hr after dosing.
The animal room was maintained at a temperature of 20 to 21 °C and relative humidity of 46-55%. The rate of air exchange was approx. 15 changes per hr and the lighting was controlled by a time switch to give 12 hr continous light and 12 hr darkness.



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated to its fasted bodyweight at the time of dosing.
Doses:
Range finding study: 2000 mg/kg (200 mg/ml; 10 ml/kg)
Main study: 2000 mg/kg (200 mg/ml; 10 ml/kg)
No. of animals per sex per dose:
Range finding: 1 male, 1 female
Main study: 5 males, 5 females
Control animals:
no
Details on study design:
Range finding: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hr after dosing and subsequently once daily for five years.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual tratment volumes. No necropsies were performed.

Main study: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hr after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoractic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Preliminary study:
range finding study: there were no deaths or clinical signs of toxicity
Based on this info. a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There where no deaths in males and females
Clinical signs:
No signs of systemic toxicity were noted during the study
Body weight:
All animals showed an expected gain in bodyweight during the study
Gross pathology:
No abnormalities were noted

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in rats was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A study was performed to assess the acute oral toxicity of the test material in Sprague-DawleyCD strain rat. This study followed OECD guideline 401 (acute oral toxicity). Following a preliminary range-finding study, a group of 5 males and 5 females was given a single oral dose of test material as a suspension in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of dosing and were killed and subjected to gross pathological examination.

There were no deaths, and no signs of systemic toxicity were noted during the study. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. LD50 was found to be greater than 2000 mg/kg bodyweight.