Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1996
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals 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:
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.
Body weight:
The test substance did not cause any changes in body weight.
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.