Bis(2-ethylhexyl) terephthalate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

single exposure followed by a 14-day observation period

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted prior to introduction of Good Laboratory Practices; data from a summary report; limited number of animals used. The study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines. The results of this study are valid for classification insofar as the conditions of exposure are at least as stringent as modern guidelines.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Five groups of two Sprague-Dawley rats were administered single doses of 200, 400, 800, 1600, or 3200 mg/kg bw of the neat test substance via an intraperitoneal injection. Animals were observed for signs of toxicity over a 14-day period following treatment.

GLP compliance:

no

Remarks:

Study conducted before GLPs

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) terephthalate

EC Number:

229-176-9

EC Name:

Bis(2-ethylhexyl) terephthalate

Cas Number:

6422-86-2

Molecular formula:

C24H38O4

IUPAC Name:

1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate

Constituent 2

Reference substance name:

Reference substance 001

Cas Number:

6422-86-2

Details on test material:

-Test substance (as cited in report): Bis (2-ethylhexyl) terephthalate
-The identity, purity, and stability of the test substance were not determined by the testing laboratory

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

Test animals:
-Sex: male
-Weight at study initiation: 188 - 253 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

unchanged (no vehicle)

Doses:

200, 400, 800, 1600, or 3200 mg/kg bw

No. of animals per sex per dose:

2 males per dose

Control animals:

no

Details on study design:

Five groups of two Sprague-Dawley rats were administered single doses of 200, 400, 800, 1600, or 3200 mg/kg bw of the neat test substance via an intraperitoneal injection. Animals were observed for signs of toxicity over a 14-day period following treatment.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 200 mg/kg bw

Mortality:

No mortality was observed during the study.

Clinical signs:

All animals appeared clinically normal throughout the study.

Body weight:

All animals gained weight during the study.

Applicant's summary and conclusion

Conclusions:

In an acute toxicity study, two male rats were administered a single dose of di (2-ethylhexyl) terephthalate by intraperitoneal injection at dose levels of 200, 400, 800, 1600, and 3200 mg/kg bw. Based on an acute intraperitoneal injection LD50 value of greater than 3200 mg/kg bw in rats, di (2-ethylhexyl) terephthalate would, at most, be slightly toxic.

Executive summary:

In an acute toxicity study, two male rats were administered a single dose of di (2-ethylhexyl) terephthalate by intraperitoneal injection at dose levels of 200, 400, 800, 1600, and 3200 mg/kg bw. The rats were observed for mortality and adverse clinical signs for a period of 14 days. No mortality or clinical signs of toxicity were observed in the study. All rats gained weight over the 14-day observation period. Based on the results of this study, the LD50 after intraperitoneal injection of di (2-ethylhexyl) terephthalate is greater than 3200 mg/kg bw.