1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Principles of method if other than guideline:

Administration of test material followed by multiple observation periods.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

EC Number:

271-089-3

EC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich

Cas Number:

68515-47-9

Molecular formula:

C34H58O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich diisotridecyl Phthalate

Details on test material:

- Physical state: clear liquid
- Composition of test material, percentage of components: used as supplied
- Other: specific gravity 0.954

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: young males
- Weight at study initiation: 321 - 374 g
- Fasting period before study: 18 h
- Housing: 6 per cage
- Diet (e.g. ad libitum): Purina Laboratory Rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 35 days

ENVIRONMENTAL CONDITIONS
-Humidity: monitored daily
-Temperature (°C): 20 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: administered as received

Doses:

- 1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10.0 g/kg bw

No. of animals per sex per dose:

- 5 animals per dose (n=5)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 2, and 4 h after dosing and daily thereafter for 14 d.
- Frequency of observations and weighing: x2 daily
- Necropsy of survivors performed: yes
- Other examinations performed: mortality rate, body weight, fecal staining, soft stool, urinary staining, nasal discharge, ocular discharge

Statistics:

No

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 other: g/kg

Remarks on result:

other: All animals survived.

Mortality:

- Mortality rate 0 %.

Clinical signs:

other: - Fecal staining and/or soft stool staining were seen 4 hours after dosing in one or two animals in the 1.0, 4.64, 6.81 and 10.0 g/kg dose groups. - Urinary staining occurred on days 1 and/or 2 in animals receiving doses of 3.16 g/kg and higher. - Ani

Gross pathology:

- Postmortem observations at termination of the study revealed findings similar to those seen in control animals killed by carbon dioxide inhalation or were considered unrelated to administration of the test material.

Other findings:

- Other observations: 1 animal in the 6.81 g/kg dose group exhibited a submandibular lesion from days 7 through 14 which was considered unrelated to the administration of the test material.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

No evidence of acute oral toxicity.

Executive summary:

Male Sprague-Dawley rats were administered a single oral exposure of DTDP (1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10.0 g/kg) via oral gavage after an 18 hour fasting period. Assessment for clinical signs of toxicity occurred at 1, 2, and 4 hours after dosing and daily thereafter for 14 days. All animals survived the exposure. There was no evidence of a wasting syndrome as assessed by changes in bodyweight. Clinical signs of urinary staining, fecal staining and stool softening were observed 2 hours post exposure in some dose groups, but these signs were not present by 3 days post exposure. It is concluded that the LD50 is greater than 10.0 g/kg.