Isooctadecanoic acid, reaction products with tetraethylenepentamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP study performed to a standardised guideline with sufficient detail to assess the quality of the data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

EC Number:

701-204-9

Cas Number:

68784-17-8

IUPAC Name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: The males were 87 days of age and the females were 94 days of age at the time of dosing.
- Weight at study initiation: The males weighed 344-393 grams, and the females weighed 215-243 grams at the time of dosing.
- Fasting period before study: yes, overnight prior to dosing
- Housing: The animals were housed individually in wire-bottom cages in an air-conditioned room.
- Diet/water (e.g. ad libitum): The animals had free access to Purina Laboratory Rodent Chow #5001 and water except during the overnight period prior to dosing when only water was available.
- Acclimation period: the animals were allowed a conditioning period of 36 days prior to dosing in the laboratory.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):23.2-23.5 °C
- Humidity (%): 57.7-64.5%
- Photoperiod (hrs dark / hrs light): The photoperiod consisted of a 12-hour light/dark cycle: lights on at 0630 and off at 1830.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single doses of 5.0 g/kg of the undiluted test material were administered intragastrically to 5 fasted animals of each sex. Five fasted undosed animals of each sex served as controls.

Doses:

Single doses of 5.0 g/kg bw.

No. of animals per sex per dose:

5/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: The animals were dosed approximately 5 hours after the onset of the light cycle. They were observed frequently for any physiological or behavioral abnormalities on the day of dosing and at least once each weekday morning and late afternoon for 13 days after treatment; on weekends they were observed once daily. On Day 14, the animals were observed once prior to sacrifice.
- Frequency of observations and weighing: The animals were weighed immediately prior to dosing and at 2, 7, and 14 days after treatment. The mean body weights of the treated animals were compared to those of the respective controls using Student's t-test
- Necropsy of survivors performed: yes, all survivors were killed following the 14-day observation period were examined for gross pathological changes. The following organs and tissues were examined: skin, spleen, pancreas, esophagus, stomach, small and large intestine, liver, adrenals, kidneys, gonads, uterus or seminal vesicles, urinary bladder, heart, thymus, salivary glands, lungs, trachea, thyroid, and fat. Abnormal tissues were preserved in 10% (v/v) neutral buffered formalin and submitted for histopathological examination.
- Other examinations performed: Tissues were submitted to Histopathology Reference Laboratory, Oakland, California, for tissue processing and preparation of routine five-micron H&E stained sections. The tissue sections were evaluated for microscopic abnormalities at Chevron Environmental Health Center, Inc.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: One treated male was observed to have reduced food consumption 24 hours following administration. No other signs of toxicity were observed.

Gross pathology:

No compound-related gross or microscopic lesions were observed. Bilated dilated renal pelves in a treated male and one female were the only gross pathologic changes observed. Upon histopathological examination, moderate hydronephrosis with mild tubular regeneration was observed in the male and trace hydronephrosis was observed in the female.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was considered to be >5 g/kg (>5000 mg/kg) based on the results.

Executive summary:

In a study conducted broadly in line with OECD guideline 401 and in accordance with GLP, single doses of 5.0 g/kg of the undiluted test material were administered intragastrically to five fasted male and female rats. No mortality was observed. The only sign of toxicity was reduced food consumption in one treated male 24 hours following adminitration. No compound-related gross or microscopic lesions were observed.