1,2,4-Benzenetricarboxylic acid, mixed branched tridecyl and isodecyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted according to OECD TG 401. GLP.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1996

Reference 2

Reference Type:

publication

Title:

Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate

Author:

ACC Phthalate Esters Panel HPV Testing Group

Year:

2006

Bibliographic source:

IUCLID 4 Data Set, HPV chemical

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate

IUPAC Name:

Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate

Constituent 2

Reference substance name:

Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

EC Number:

222-020-0

EC Name:

Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Cas Number:

3319-31-1

Molecular formula:

C33H54O6

IUPAC Name:

tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test Subjects
Age at study initiation: 6 weeks old for both sexes.
Weight at study initiation: 149-163 g for male; 126-140 g for female
No. of animals per sex per dose: 5 per sex per dose group

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Route of administration: Oral (by single-dose gavage)

Doses:

0(vehicle) and 2,000 mg/kg

No. of animals per sex per dose:

5 animals/ sex/ dose

Control animals:

yes

Details on study design:

Vehicle: Corn oil. 40.0w/v% for 2000 mg/kg.

Clinical observations performed and frequency: Each rat was weighed immediately prior to treatment, 7 and 14 days after post-treatment observation period. The rats were observed each hour to 6hr, after that, 2 times for one day during this time for signs of toxicity.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no fatalities noted

Mortality:

No deaths were recorded in treated and control group.

Clinical signs:

other: Loosening erring of the stool attributable to the treatment with corn oil was observed for 3 hours from the administration for both sexes in the groups given 0 and 2000 mg/kg. However, no deaths occurred of either male or female animals.

Gross pathology:

No macroscopic abnormalities that could be attributes to treatment with the test substance were seen on pathological examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for the test material Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate was > 2000 mg/kg/day for male and female rats.

Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The LD50 for the test material Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate was > 2000 mg/kg/day for male and female rats.

Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.