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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:
March, 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not conducted according to an existing OECD guideline, and no data on GLP, but acceptable basic information.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this Range Finding Acute Oral Toxicity study the acute oral toxic effects of Santicizer 141 was tested in Sprague Dawley strain albino male and female rats. The undiluted compound was fed by stomach tube at 6 doses (2000, 5010, 7940, 10000, 12600, and 15800 mg/kg). Number of animals were: 1 female at 2000, 5010, and 7940 mg/kg; 5 animals/sex at 10000, 12600, and 15800 mg/kg. Daily observations were made for 10 days for toxic symptoms and the viscera of the test animals were examined macroscopically.
GLP compliance:
not specified
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): Santicizer 141
- Lot/batch No.: QK 735

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS: No data

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
2000, 5010, 7940, 10000, 12600, and 15800 mg/kg
No. of animals per sex per dose:
2000, 5010, and 7940 mg/kg: 1 female; 10000, 12600, and 15800 mg/kg: 5 animals/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: observation of toxic symptoms: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Mortality:
1 female died at dose 12600 and 15800 mg/kg. Survival time was 3 to 5 days.
Clinical signs:
Toxic symptoms included diarrhea for 1 day, reduced activity and appetite, and tremors and increasing weakness to near collapse lasting 5 to 7 days in animals of the last 3 groups.
Body weight:
225 to 265 gr.
Gross pathology:
At autopsy there were hemorrhagic areas of the liver, lungs, and kidneys, and intestinal inflammation. Surviving animals were sacrificed 10 days after dosing. Hemorrhagic areas of the lungs were observed in a few instances; otherwise the viscera appeared normal by macroscopic examination.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was found to be > 15800 mg/kg. Based on these results and according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 the substance does not have to be classified.
Executive summary:

In this Range Finding Acute Oral Toxicity study the acute oral toxic effects of Santicizer 141 was tested in Sprague Dawley strain albino male and female rats. The undiluted compound was fed by stomach tube at 6 doses (2000, 5010, 7940, 10000, 12600, and 15800 mg/kg). Number of animals were: 1 female at 2000, 5010, and 7940 mg/kg; 5 animals/sex at 10000, 12600, and 15800 mg/kg. Daily observations were made for 10 days for toxic symptoms and the viscera of the test animals were examined macroscopically. Toxic symptoms included diarrhea for 1 day, reduced activity and appetite, and tremors and increasing weakness to near collapse lasting 5 to 7 days in animals of the last 3 dose groups. One female died at dose 12600 and at 15800 mg/kg. Survival time was 3 to 5 days. At autopsy there were hemorrhagic areas of the liver, lungs, and kidneys, and intestinal inflammation. Surviving animals were sacrificed 10 days after dosing. Hemorrhagic areas of the lungs were observed in a few instances; otherwise the viscera appeared normal by macroscopic examination. The oral LD50 was thus found to be > 15800 mg/kg. Based on these results and according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 the substance does not have to be classified.