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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP compliance is claimed, however, the final report includes an audit as well as quality assurance inspections.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
The final report includes an audit and quality assurance inspections.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Portage, MI
- Weight at study initiation: approximately 135 g
- Fasting period before study: yes, animals were fasted for 18 h prior to dose administration
- Housing: individually in suspended, stainless steel cages (25 x 17.8 x 17.8 cm)
- Diet (e.g. ad libitum): Purina Rodent Chow 5001 (Ralston Purina Co.) ad libitum except 18 h fasting period prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 333.3 and 666.7 mg/mL
- Amount of vehicle (if gavage): 15 mL/kg
- Lot/batch no.: Lot no. 790670 (Fischer)

MAXIMUM DOSE VOLUME APPLIED: 10000 mg/kg
Doses:
5000 mg/kg and 10000 mg/kg
No. of animals per sex per dose:
2 male and 2 female at 5000 mg/kg
5 male and 5 female at 10000 mg/kg
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation are performed once daily for 14 days and more frequently on the day of dosing
- Necropsy of survivors performed: gross necropsy performed on all animals
- Other examinations performed: body weights performed prior to dosing
Statistics:
No statistical methods reported.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during this study.
Clinical signs:
Decreased motor activity was seen in 9 out of 10 animals in the high dose group within 24 hours following the high dose administration. During this same period, diarrhoea was observed in 2 of 5 high dose female rats and 1 of 5 low dose male rats. All rats appeared normal for the remainder of the observation period.
Body weight:
Recorded prior to dosing.
Gross pathology:
One male in the high dose group was found to have dark red edges on the spleen.
Other findings:
No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test report describes a valid guideline study, with auditation and quality assurance inspections of the final report.The acute oral median lethal dose (LD50) for the test material was determined to be greater than 10000 mg/kg in male and female rats. Thus, the test substance can be considered as not acutely toxic via the oral route.
Executive summary:

An acute oral study was conducted using a similar procedure to that described in the current OECD Guideline 401 (Reckers, 1981). The test material (CAS No. 91648-65-5) was administered at dose levels of 5000 mg/kg, to two male and two female rats, and 10000 mg/kg to five male and five female rats by oral gavage.

The rats were observed for 14 days after test material administration. General signs of intoxication exhibited by the rats following dosing included decreased motor activity and diarrhoea. There were no mortalities in either dose group. No gross pathologic alterations were noted among the animals at study termination. The acute oral median lethal dose (LD50) for the test material was determined to be greater than 10000 mg/kg in male and female rats.