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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:
04/09/1996-03/10/1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Further details are confidential.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River UK

- Age at study initiation: 5 -8 weeks

- Weight at study initiation: male rats weighed 161 to 169g, and the females 128 to 151

- Fasting period before study: overnight

- Housing: the animals were housed in groups of up to 5 by sex in solid floor polypropylene cages furnished with woodflakes

- Diet:ad libitum, except overnight fast immediately before and two hours immediately after dosing

- Water: ad libitum, except overnight fast immediately before and two hours immediately after dosing

- Acclimation period: minimum of 5 days




ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20-22

- Humidity (%): 49-61

- Air changes (per hr): ca.15

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


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg


DOSAGE PREPARATION (if unusual): The test material was freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP. A warming bath was used to aid preparation.


Doses:
2000mg/kg bw
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were weighed on days 0,7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
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 at necropsy.
Other findings:
Red/brown staining around the snout were noted in the male at 0.5, 1 and 2 hour observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of >2000mg/kg was determined in a reliable study conducted according to the appropriate guideline. The study was compliant with GLP.
Executive summary:

In the acute oral toxicity study, 2000 mg/kg bw of test material in arachis oil was administered orally to 5 male and 5 female rats. During the 14 -day study period, the animals were weighed on days 0, 7 and 14 and any clinical and bihavioural signs were noted regularly. Necropsy was performed at the end of the study period.

There were no deaths during the 14 -day study period. No signs of systemic toxicity were noted and all animals showed the expected body weight gain during the study period. No abnormalities were noted at nectorpsy.

An LD50 value of > 2000 was reported. The study was conducted according to an appropriate OECD test guideline and in compliance with GLP.