Amides, C16-C18 (even) , N,N'-ethylenebis

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

analytical purity of test substance not specified, 1.5 mL/ 100 g bw of non aqueous liquid administered at once

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-C18 (even) , N,N'-ethylenebis

EC Number:

931-299-4

Cas Number:

68390-94-3

Molecular formula:

not available UVCB

IUPAC Name:

Amides, C16-C18 (even) , N,N'-ethylenebis

Constituent 2

Reference substance name:

Amides, C16-C18 (even), N,N’-ethylenebis

IUPAC Name:

Amides, C16-C18 (even), N,N’-ethylenebis

Test material form:

not specified

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, New York, USA
- Weight at study initiation: males 112 - 131 g and females 87 -103 g
- Fasting period before study: over night (~ 18 h)
- Housing: Animals were housed five per cage by sex in suspended solid-bottom polycarbonate cages. The cage dimensions were 55.9 x 31.8 x 20.3 cm and were fitted with grommets to fit the external-to-cage watering system.
- Diet: ad libitum (NIH 07 Open Diet, Zeigler Bros., Inc., Gardners, PA, USA)
- Water: tap water, ad libitum
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): mean 24, range 20 - 27
- Humidity (%): mean 47, range 32 - 72
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 15 mL/kg bw in 3 doses to a total of 45 mL/kg bw
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg bw

Doses:

single dose of 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: 5 animals of each sex served as vehicle controls

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed 4x on the day of treatment, and the observations were separated by 1 - 1.5 h. On the 13 remaining days of the study the animals were observed 2x each day (AM and PM), and the observations were separated by at least 4 h.
- Necropsy of survivors performed: yes, external examination including body orifices, and an internal examination of all of the following tissues: Gross lesions; skin; mandibular lymph node; mammary gland; salivary gland; thigh muscle; sciatic nerve; sternebrae, vertebrae or femur including marrow; costochondral junction, rib; thymus; larynx; trachea; lungs and bronchi; heart; thyroid; parathyroids; esophagus; stomach; duodenum; jejunum; mesentery; aorta; ileum; colon; cecum; rectum; mesenteric lymph node; liver; pancreas; spleen; kidneys; adrenals; urinary bladder; seminal vesicles; prostate; testes; ovaries; uterus; nasal cavity; brain; pituitary; spinal cord (if neurologic signs are present); eyes.
- Other examinations performed: All gross observations were recorded by animal on Acute Study Data Sheets. Initial, 7-day, 15-day and final body weights were also recorded for each animal.

Statistics:

- Weight gain was calculated by (14 Day Body Weight - Mean Initial Body Weight)/Mean Initial Body Weight
- No other statistical tests were mentioned

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Not observed.

Clinical signs:

other: Not observed.

Gross pathology:

No abnormalities observed.

Other findings:

- Other observations: The "ruffled coat" and diarrhea noted among vehicle controls was attributable to the large volume of vehicle (corn oil) received by these animals.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Executive summary:

The absence of any adverse reaction relating to treatment like mortality, abnormal clinical signs, depressed growth rate or gross anatomical abnormalities at necropsy indicates that the test substance is non-toxic for F344 rats. According to the criteria laid down in Regulation (EC) No. 1272/2008 the substance does not have to be classified for acute toxicity via the oral route.