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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Comparable to guideline study, perdates GLP, minor restrictions in reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
The test material was suspended in corn oil and orally administered to a group of 10 males and 10 females in one single dose of 5 to 20 ml per kg body weight. After treatment the animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Soxinol EZ (WTR-No. 38 )
- Physical state: White-coloured powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Experimental Animals, Shizuoka
- Age at study initiation: 7-week old
- Weight at study initiation: Male 230-260 g, Female 180-210 g
- Housing: 10 animals/ cage
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 1°C
- Humidity: 60 ± 10% R.H.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
500, 650, 845, 1000, 1300, 1700, 2200, 2500, 3850 and 5000 mg/kg bw
No. of animals per sex per dose:
10 males and 10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 960 mg/kg bw
Based on:
test mat.
95% CL:
1 620 - 2 370
Sex:
female
Dose descriptor:
LD50
Effect level:
2 280 mg/kg bw
Based on:
test mat.
95% CL:
1 790 - 2 910
Mortality:
Death was noted 1-7 days after administration of 1000 mg/kg and above.
Clinical signs:
At 500 mg/kg: No toxic symptoms were seen.
At 650 and 845 mg/kg: At 1-2 hours after administration, rapid respiration, decrease of motor ataxia and piloerection were developed. The symptoms disappeared within 2-3 days.
At 1000 mg/kg and above: In addition to the above toxic symptoms, irregular respiration, dyspnea, diarrhea, incontinence of urine, ataxia in hind limbs or whole body were observed.
Body weight:
No data
Gross pathology:
No remarkable changes were found in any groups of the test animals.

Applicant's summary and conclusion