Bis(2-ethylhexyl) terephthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Reliable without restriction; study followed GLPs and TSCA FHSA Regulations (1979): 16 CFR Part 1500.40 (Hazardous Substances and Articles, Administration and Enforcement Regulations).

Data source

Reference

Reference Type:

other: unpublished Eastman Kodak report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: TSCA FHSA Regulations (1979): 16 CFR Part 1500.40 (Hazardous Substances and Articles, Administration and Enforcement Regulations)

Deviations:

not specified

GLP compliance:

yes

Limit test:

yes

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 material (as cited in study data): Di (2-ethylhexyl) terephthalate: synonyms, Kodaflex DOTP, Dioctyl terephthalate, Eastman DOTP Plasticizer.

Test animals

Species:

rat

Strain:

other: CD(SD)BR VAF/Plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
-Sex: male and female
-Age at study initiation: 7-8 weeks (males); 8-9 weeks (females)
-Weight at study initiation: 211-241 g (males); 202-218 g (females)
-Housing: individually housed in suspended, stainless-steel wire mesh cages
-Diet: Agway Prolab certified Animal Diet (pellets)
-Water: Monroe County, NY local water ad libitum
-Method of animal distribution: randomly assigned to the study based on a computer-generated list

Environmental Conditions:
-Temperature: 68 - 72 °F
-Humidity: 44-55% relative humidity
-Photoperiod: 12 hours light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Animals were given a single dose of the neat test substance.

Doses:

5000 mg/kg bw (single dose)

No. of animals per sex per dose:

5 rats/sex

Control animals:

no

Details on study design:

Animals were observed for signs of toxicity three times on the day of dosing, and daily for two weeks thereafter. Body weights were measured on Days 0, 7, and 14. All animals were necropsied at the completion of the 14-day observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed during the study.

Clinical signs:

other: Clinical abnormalities were limited to oily, unkempt inguinal hair for all animals on Days 1 and 2 of the study, and yellow discolored inguinal hair for two female rats on Day 1.

Gross pathology:

No treatment-related changes were observed at necropsy.

Other findings:

In the absence of significant gross organ lesions, no tissue was collected for microscopic examination.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under conditions used in this study, di (2-ethylhexyl) terephthalate was practically nontoxic by the oral route in rats. The single dose oral LD50 in rats was greater than 5000 mg/kg bw.

Based on an acute oral LD50 value of greater than 5000 mg/kg bw in rats, di (2-ethylhexyl) terephthalate is not classified for classification and labeling for acute lethality by the oral route under GHS.

Executive summary:

In an acute oral toxicity study, five rats per sex were administered a single dose of di (2-ethylhexyl) terephthalate by oral gavage at a dose level of 5000 mg/kg bw. The rats were observed for mortality and adverse clinical signs for a period of 14 days. No mortality was observed in the study. Clinical signs of toxicity were limited to oily, unkempt inguinal hair for all animals on Days 1 and 2 of the study, and yellow discolored inguinal hair for two female rats on Day 1. No other clinical abnormalities were noted throughout the study. All rats gained weight over the 14-day observation period. Based on the results of this study, the LD50 per os of di (2-ethylhexyl) terephthalate is greater than 5000 mg/kg bw.