Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich

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:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 401

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limit dose reduced from 5000 mg/kg to 2000 mg/kg

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-740-6

EC Name:

-

Molecular formula:

Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)

IUPAC Name:

Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich

Details on test material:

Test article is a colorless homogeneous liquid. This material as stated in the Product Physical and Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and five female young adult Sprague-Dawley rats obtained from Taconic Farms (Germantown, N.Y.) were used in this study. The body weights at dosing ranged from 234-261 grams for the males and 186-221 grams for the females. The terminal weights ranged from 303- 359 for the males and 226-259 for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 69-74° F with a relative humidity of 38-62%.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

Single dose of 100% test article was administered

Details on oral exposure:

All animals were fasted overnight and dosed via oral gavage. Body weights were recorded prior to fasting and on Days 0, 7, and 14.
The test article was dosed with a blunted needle attached to a 1 cc syringe. Food was returned to each animal immediately after dosing.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Signs of toxicity were recorded at approximately 0.5-, 1- and 4-hours after test substance administration and daily thereafter with the exception of weekends. The condition of each animal (live,dead,moribund) was checked at least once daily in the morning except on day 6 when they were checked in the afternoon. All animals were euthanized by overexposure to carbon dioxide and then necropsied at the termination (day 14) of the study.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived treatment with the test article.

Clinical signs:

other: The following clinical observations that may have been caused by treatment were noted in one or more animals: soft stool, chromorhinontea, and alopecia on both fore paws.

Gross pathology:

There were no gross pathological changes noted during necropsy that could be related to treatment

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich is >2000 mg/kg. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich for acute oral toxicity under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich was administered by oral gavage to 5 male and 5 female Sprague Dawley rats at the limit dose of 2000 mg/kg to assess the acute oral lethality. Clinical observations were made at 0.5, 1, 4 hours and daily thereafter exposure. No adverse clinical effects noted. At the end of the study, the LD50 was determined to be greater than 2000 mg/kg. This finding does not warrant the classification of

1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich

under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.