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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:
22 April 1999 to 23 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: solid
- Storage condition of test material: room temperature and humidity

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA
- Weight at study initiation: 206-275 g (male); 200-237 g (female)
- Fasting period before study: 16-20 hours prior to dosing
- Housing: suspended wire cages
- Diet (e.g. ad libitum): Purina Rat Chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
DOSAGE PREPARATION
10 g of test material was added to 40 mL of corn oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 hours postdose and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weights were recorded immediately pretest, at death and at termination in the survivors

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:
Nine out of ten animals survived. One male was sacrificed on day 2 due to moribund condition.
Clinical signs:
Physical signs in the surviving animals included: lethargy, chromorhinorrhoea, ataxia, sagging eyelids, soiling of the anogenitial area, diarrhoea, red staining of the nose/mouth area, wetness of the anogenital area and localised alopecia. Similar symptoms were noted in the animal that was sacrificed.
Body weight:
Body weight changes in surviving animals were normal.
Gross pathology:
Necroposy of the survivors was normal in 2/9 animals. Kidney abnormalities were noted in 7/9 survivors. Necropsy of the sacrificed animal revealed abnormalities of the intestines, as well as red staining of the nose/mouth area.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material was >2000 mg/kg.
Executive summary:

In a GLP compliant acute oral toxicity study conducted in line with standardised guideline EPA OPPTS 870.1100, the acute oral toxicity of the test material was determined. Under the conditions of the test, the LD50 of the test material in rats was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for this endpoint.