Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
other: US EPA Pesticide Assessment Guidelines Subdivision F, 81-1
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes
Test type:
other: acute oral toxicity
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99.9%

Test animals

Species:
rat
Strain:
other: Crl:CD®BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 57 days (male rats); 64 days (female rats)
- Weight at study initiation: 212.1-229.4 g (male fasted weight); 184.5-197.6 g (female fasted weight)
- Fasting period before study: approximately 18 hours
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): ad libitum, except for approximately 18 hours prior to 3 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: approximately 3.16 mL/kg body weight
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily throughout the study. Rats were observed daily (weekends excluded) for clinical signs of toxicity.
-Frequency of weighing: Rats were weighed daily (weekends excluded).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No adverse effects observed. No clinical signs of toxicity and no gross lesions observed.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
Intermittent weight losses of up to approximately 6% of previously measured body weight were observed in some female animals during the study.
Gross pathology:
No gross lesions were present.

Applicant's summary and conclusion

Interpretation of results:
other: very low toxicity
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

LD50 >5000 mg/kg
Executive summary:

Single doses of the test substance were administered by intragastric intubation to fasted male and female rats at a dosage of 5000 mg/kg of body weight. The rats were observed for clinical signs of toxicity and mortality over a 14-day observation period. No deaths occurred during the study. Intermittent weight losses of up to approximately 6% of previously measured body weight were observed in some female animals during the study. No clinical signs of toxicity were observed. No gross lesions were observed in study rats at necropsy. Under the conditions of this test, the oral LD50 for the test substance was >5000 mg/kg.