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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: data contained in EU risk assessment report of the substance - credibility is assumed. Reference to origin (Shell Development Company)

Data source

Referenceopen allclose all

Reference Type:
other: EU risk assessment report
Title:
No information
Author:
Federal Institute for Occupational Safety and Health, Division for Chemicals and Biocides Regulation, Germany
Year:
2009
Bibliographic source:
European Union Risk Assessment Report, 4-tert-butylbenzoic acid, CAS No: 98-73-7, EINECS No: 202-696-3, p. 50, Final Approved Version, July 2009
Reference Type:
study report
Title:
Unnamed
Year:
1950

Materials and methods

Principles of method if other than guideline:
Determination of oral LD 50 of the test substance by intragastical administration of different concentrations in an aqueous suspension of gum acacia.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report) and analytical purity:
4-tert-butylbenzoic acid, containing 5 % of the m-compound (3-tert-butylbenzoic acid, Shell production grade)

Test animals

Species:
mouse
Strain:
other: Swiss inbred
Sex:
not specified
Details on test animals and environmental conditions:
white mice

Administration / exposure

Route of administration:
other: intragastic
Vehicle:
other: gum acacia in water
Details on oral exposure:
administration of an aqueous suspension of the test substance in gum acacia
Doses:
350, 400, 550, 600, 650, 700, and 800 mg/kg bw
No. of animals per sex per dose:
10

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
568 mg/kg bw

Any other information on results incl. tables

Doses of 350, 400, 550, 600, 650, 700, and 800 mg/kg bw were given to 10 mice each resulting in the following mortalities: after administration of 350 mg/kg 1/10 mice died on day 2; after administration of 400 mg/kg 4/10, after 550, 600, and 650 mg/kg 5/10 each, after 700 mg/kg 7/10, and after 800 mg/kg all mice died within 24 hours. The mice were mildly depressed within 1/3 hours after dosing. Within an hour, signs of muscular distress, marked incoordination and the Straub tail effect (spinal cord excitant) were present. At 5 hours a paralysis of the forelegs was evident in two thirds of the mice. In 3 of these, response of the tail and paws to painful stimuli was depressed or absent, but recovery occasionally followed even this deep depression. The pathologic changes noted in the 22 mice autopsied included signs off lung irritation, hemorrhage of the lungs, increased pigmentation of the liver, denuding of the epithelium of the intestines, and hyperemia of the intestines.

Applicant's summary and conclusion