Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study predates Good Laborary Practices

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Report predates GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisononyl benzene-1,2,4-tricarboxylate
EC Number:
258-847-9
EC Name:
Triisononyl benzene-1,2,4-tricarboxylate
Cas Number:
53894-23-8
Molecular formula:
C36H60O6
IUPAC Name:
triisononyl benzene-1,2,4-tricarboxylate
Test material form:
liquid
Details on test material:
Production sample
Specific details on test material used for the study:
Visual description of substance was "Clear yellow, slightly viscous liquid with a faint odor."

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Described in study report as "Adult male albino rats of the Holtzman (Sprague-Dawley-derived) strain."
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
A single dose was administered by oral gavage as either the neat substance (5000 and 10000 mg/kg) or as a 3% weight per volume solution (419 and 1450 mg/kg) in corn oil. All animals were fasted three to four hours prior to dosing.
Doses:
417, 1450, 5000, and 10000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Rats were observed for mortality and toxic effects immediately after dosing; at one, four, and 24 hours; and once dally thereafter for a total of 14 days.
Body weights were measured initially and terminally.
Statistics:
Statistical analysis was described as "Litchfield, J. T., and Wilcoxon, F., J. Pharmacol. Exptl. Therap. 96, 99, 1949"

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred at any of the tested doses.
Clinical signs:
At doses of 5000 or 10000 mg/kg animals showed slight depression by one hour and excessive urination and/or diarrhea. Complete recovery occurred by 48 hours (5000 mg/kg level) or Day 5 (10,000 mg/kg level)
Body weight:
No effects on body weight were reported.
Gross pathology:
No observable gross pathology was found

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute oral exposure to the test substance at doses up to 10,000 mg/kg did not result in any mortality in a 14-day post-exposure observation period. The results indicate negligible potential for acute oral toxicity.
Executive summary:

Groups of five male Sprague-Dawley rats were administered 419, 1450, 5000, or 10000 mg/kg triisononyl trimellitate by oral gavage and observed 14 days following exposure. No mortality occurred. At 5,000 and 10,000 mg/kg activity was slightly depressed one hour following exposure, with observation of excessive urination and/or diarrhea. Complete recovery was reported by 48 hours (5,000 mg/kg) or five days (10,000 mg/kg). The results indicate negligible potential for acute oral toxicity.