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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:
weight of evidence
Study period:
February 1969 - March 1969
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Too concise study report, study not conducted according to an existing guideline. No GLP. Acceptable basic data.
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 test the undiluted compound was fed by stomach tube to 11 Sprague-Dawley strain albino male and female rats in increasing doses at increments of various fractional log intervals at 7 levels (1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg).
Observations were made for toxic signs during 9 days, surviving animals were sacrificed 9 days after dosing, and the viscera of the test animals were examined macroscopically. Finally, an LD50 was supplied.
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 122

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 220 to 260 g.

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg
No. of animals per sex per dose:
At 1000, 2000, 3160, 5010, 7940, and 12600 mg/kg: 1 animal (male or female)
At 15800 mg/kg: 3 females and 2 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No statistical analysis was performed.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 800 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
Toxic symptoms included slight weakness in animals dosed at the two highest levels (12600 and 15800 mg/kg) for 3 to 4 days.
Body weight:
No data
Gross pathology:
In all surviving animals, sacrificed 9 days after dosing, the viscera appeared normal by macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The highest dose of 15800 mg/kg was found to be non-lethal by single oral ingestion in 5 rats (3 females, 2 males), observed over a period of 9 days. The oral LD50 of Santicizer 141 is therefore greater than 15800 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.
Executive summary:

In this range finding acute oral toxicity test the undiluted compound was fed by stomach tube to 11 Sprague-Dawley strain albino male and female rats in increasing doses at increments of various fractional log intervals at 7 levels (1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg). Observations were made for toxic signs during 9 days, surviving animals were sacrificed 9 days after dosing, and the viscera of the test animals were examined macroscopically. Finally, an LD50 was supplied. Toxic symptoms included slight weakness in animals dosed at the two highest levels (12600 and 15800 mg/kg) for 3 to 4 days. No mortality occurred. All surviving animals were sacrificed 9 days after dosing. The viscera appeared normal by macroscopic examination. The oral LD50 of Santicizer 141 is greater than 15800 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.