Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-04-29 - 1996-07-02 (experimental phase)
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Storage condition of test material:
room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK.
- Weight at study initiation: body weight: female: 129 - 148 g, male: 141 - 171 g
- Age of test animals: 5 - 8 weeks
- Fasting period before study: overnight before administration, 2 hours after dosing
- Housing: 5 rats per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 48 - 58
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Arachis Oil BP
- Concentration in vehicle: 200 mg test substance per ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 5 female rats, 5 male rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Preliminary study:
There were no deaths. Red/brown-coloured faeces were noted in both animals one day after dosing. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted during the study.
Gross pathology:
No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

Acute oral toxicity was analyzed in a GLP study performed according to OECD test guideline 401. Five male and female Sprague-Dawley CD rats received doses of 2000 mg/kg bw by gavage. Since no mortality was noted during the 14-day observation period, the LD50 was found to be >2000 mg/kg bw. Due to the observed LD50 in a study performed equivalent to OECD guideline, no classification according EU and GHS criteria is required according Directive 67/548/EC or EU GHS criteria (Regulation (EC) N° 1907/2006).