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Toxicological information

Acute Toxicity: other routes

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.