Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
January, 1971
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:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The undiluted compound was dosed by intraperitoneal injection to Swiss-Webster strain albino male and female mice. After the approximate Minimum Lethal Dose was determined, groups of mice equally divided as to sex were dosed in increasing doses at increments of 0.l fractional log intervals at 4 levels (631, 794, 1000, and 1260 mg/kg) designed to blanket the toxicity range, thereby supplying data for calculation of the LD50 which was done according to the method of E. J. de Beer. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically.
GLP compliance:
not specified
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

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
unchanged (no vehicle)
Doses:
631, 794, 1000, and 1260 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 930 mg/kg bw
Remarks on result:
other: Mice; Lower and upper limits 850 and 1020 mg/kg respectively

Any other information on results incl. tables

Survival time was 1 to 5 days with most deaths occurring within 3 days. Toxic signs included reduced appetite and activity, lethargy, increasing weakness, slight tremors, collapse, and death. At autopsy there was lung hypomania, slight liver discoloration, and gastrointestinal inflammation at area of infection. Surviving animals were sacrificed 7 days after dosing. The viscera appeared normal by macroscopic examination.

Applicant's summary and conclusion

Conclusions:
The intraperitoneal LD50 for male and female mice was placed at 930 mg/kg with lower and upper limits of 850 to 1020 mg/kg. Santicizer 141 does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 (CLP/EU-GHS).
Executive summary:

The acute inhalation toxicity of Santicizer 141 towards mice was investigated. The undiluted compound was dosed by intraperitoneal injection to Swiss-Webster strain albino male and female mice. After the approximate Minimum Lethal Dose was determined, groups of mice equally divided as to sex were dosed in increasing doses at increments of 0.l fractional log intervals at 4 levels (631, 794, 1000, and 1260 mg/kg) designed to blanket the toxicity range, thereby supplying data for calculation of the LD50 which was done according to the method of E. J. de Beer. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically. Survival time was 1 to 5 days with most deaths occurring within 3 days. Toxic signs included reduced appetite and activity, lethargy, increasing weakness, slight tremors, collapse, and death. At autopsy there was lung hypomania, slight liver discoloration, and gastrointestinal inflammation at area of infection. Surviving animals were sacrificed 7 days after dosing. The viscera appeared normal by macroscopic examination. The intraperitoneal LD50 for male and female mice was placed at 930 mg/kg with lower and upper limits of 850 to 1020 mg/kg. Santicizer 141 does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 (CLP/EU-GHS).