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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:
other: Comparable to guideline study, Predates GLP and test guidelines, minor restrictions, 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:
Method: other: Predates GLP and test guidelines
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 TP
- Physical state: Light yellow-coloured liquid
- Purity: Commercial grade

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 240-260 g, female 180-200 g
- Housing: 10 animals/ cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2500 mg/kg bw
Doses:
100, 250, 500, 750, 1000, 1500, 2000 and 2500 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

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 430 mg/kg bw
95% CL:
1 100 - 1 860
Remarks on result:
other: The value is determined for 47.5% solution of the substance; recalculated for pure substance it corresponds to LD50 of 672 mg/kg bw.
Sex:
female
Dose descriptor:
LD50
Effect level:
1 330 mg/kg bw
95% CL:
961 - 1 840
Remarks on result:
other: The value is determined for 47.5% solution of the substance; recalculated for pure substance it corresponds to LD50 of 625 mg/kg bw.
Mortality:
At 750 mg/kg bw and above: Death was found mostly 4-16 hours after treatment.
Clinical signs:
At 100 mg/kg bw: No toxic signs were found.
At 250 and 500 mg/kg bw: About 1 hours after administration, decrease of spontaneous motor activity, piloerection and irregular respiration were developed, and disappeared in 1-2 days.
At 750 mg/kg bw and above: In addition to the above toxic symptoms, dyspnea, diarrhea and ataxia in hind limbs or whole body were observed. Toxic symptoms of surviving animals disappeared in 4-7 days.
Gross pathology:
No remarkable changes were found in any groups of the test animals.

Any other information on results incl. tables

No sex difference was observed in type, intensity and duration of the toxic symptoms.

Applicant's summary and conclusion