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Diss Factsheets

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:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP conditions, used methods and results are preliminary documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The diluted compound was fed by stomach tube to Sprague-Dawley strain albino male and female rats. After the approximate Minimum Lethal Dose was determined, groups of male and female rats were fed in increasing doses at increments of 0.1 fractional log intervals at four levels designed to blanket the toxicity range thereby supplying data for calculation of the LD50 which was done according to a modification of the method of E. J. de Beer. Observations were made for toxic symptoms and the viscera of the animals that succumbed were examined macroscopically.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Details on test material:
Name of test material (as cited in study report): Santonox

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
1580, 2000, 2510, 3160 mg/kg bw
No. of animals per sex per dose:
5

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 315 mg/kg bw
95% CL:
ca. 1 970 - ca. 2 730
Remarks on result:
other: Experiment 19
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 420 mg/kg bw
95% CL:
ca. 2 060 - ca. 2 845
Remarks on result:
other: Experiment 20
Clinical signs:
other: Toxic symptoms included severe diarrhea, marked weight loss, increasing weakness, and collapse.
Gross pathology:
At autopsy there was gastroenteritis, liver discoloration, and severe renal hyperemia.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
A study in albino male and female rats suggested that Santonox was slightly toxic upon oral ingestion. The oral LD50 was placed at 2315 and 2420 mg/kg bw in two independent experiments. The study was not performed according to the general guidelines for acute toxicity testing under GLP conditions and poorly documented, since it dates from 1965. Nevertheless the data give an indication of acute toxicity upon oral administration to rats.