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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:
2007-06-12 to 2008-03-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 420 and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ENORDET O241
- Physical state: Clear, colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: not reported
- Fasting period before study: over night
- Housing: groups of up to four, suspended solid-floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees Celsius
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

IN-LIFE DATES: From: 2008-02-19 To: 2008-02-20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 2.53 ml/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on available information on the toxicity of the test material
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 female rats
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, morbitity and mortality check were made twice daily.
Statistics:
None provided

Results and discussion

Preliminary study:
No toxicity was observed at a dose level of 2000 mg/kg, when tested by gavage, on one female rat.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected gains in bodyweight
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
none reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Executive summary:

In an acute oral toxicity study, 5 fasted female Sprague-Dawley CD strain rats were given a single oral dose of ENORDET O241 at dose of 2000 mg/kg bw and observed for 14 days. There were no treatment related clinical signs, necropsy findings or chantes in body weight. The oral LD50 was determined to be greater than 2000 mg/kg in females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to OECD Guideline 420 and GLPs.