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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sultzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 206-230 g; females: 170-181 g
- Fasting period before study: overnight (prior to dosing) until approximately 3.5 hours after administration
- Housing: individually in polycarbonate cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (RMH-B, Hope Farms, Woerden, The Netherlands)
- Water: tap-water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for any signs of toxicity approximately once every two hours after dosing and once daily thereafter for 14 days. Individual bodyweights were measured weekly.
- Necropsy of survivors performed: Yes, at the end of the study (day 14), all animals were anaesthetised by CO2/O2 inhalation, subsequently killed by CO2 and subjected to necropsy
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No signs of systemic toxicity were observed during the 14 day observation period.
Body weight:
Mean body weights on days 0, 7, 14:
- Males: 215, 293, 358 g
- Females: 177, 206, 218 g
Gross pathology:
Macroscopic examination of animals at termination revealed firm and/or small white/greyish irregular patches in the forestomach of all animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified