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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study predates GLP

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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
Study 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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not described in study report

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test substance was applied to the closely clipped, abraded abdominal skin of each rabbit beneath a binder of rubber dam. The trunk of each animal was then wrapped in gauze and adhesive tape, and the animals were collared to prevent ingestion of the compound. After an exposure period of 24 hours, the binders and collars were removed, and the abdominal skin was cleansed with corn oil to remove any compound residue.
Duration of exposure:
24 hours
Doses:
50, 200, 794, and 3160 mg/kg
No. of animals per sex per dose:
Four
Control animals:
no
Details on study design:
Mortality and toxic effects were recorded immediately following application and at one, four, and 24 hours. Following the initial period observations were performed once daily thereafter for a total of 14 days. Dermal irritation recorded at 24 hours and once daily thereafter for a total of 14 days. Body weights were measured initially and terminally.
Statistics:
No details provided in the study report

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 3 160 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred at any of the dosage levels tested. The acute dermal LD50 was, therefore, assumed to be greater than 3160 mg/kg of body weight.
Clinical signs:
Depression, soft feces, and/or few feces were noted in two animals at the 3160 mg/kg level.
Body weight:
Two animals exposed to 3160 mg/kg exhibited terminal body weight loss.
Gross pathology:
Study report indicates "Gross organ alterations were limited to those associated with incidental disease." This is interpreted as no treatment related gross pathology findings.
Other findings:
Skin irritation was slight and consisted of erythema (moderate in two animals at 3160 mg/kg) in all animals at 24 hours which persisted for two to six days. Desquamation was observed in one low level animal on Days 5 and 6.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acute dermal exposure to the test substance at doses up to 3,160 mg/kg did not result in any mortality in a 14-day post-exposure observation period. The results indicate negligible potential for acute dermal toxicity.
Executive summary:

Groups of four male or female New Zealand White rabbits were exposed to 50, 200, 794, or 3160 mg/kg on abraded skin using occulsive dressing for 24 hours. Rabbits were observed for 14 days following exposure. No mortality occured. Effects were limited to rabbits exposed to 3160 mg/kg, where two rabbits were reported to show depression, soft feces, and/or few feces, and terminal body weight loss. There was some indication of slight skin irritation in all animals at the 24 hour time point, but completely resolved by the seventh day following exposure. The results indicate negligible potential for acute dermal toxicity.