N,N'-ethane-1,2-diylbisoleamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. 1.5 mL/ 100 g bw of non aqueous liquid administered at once.

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:

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

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Acrawax C, Disp. 52-464, (GC-Q7)
- Analytical purity: no data
- Lot/batch No.: 125257
- Stability under test conditions: stable under ambient storage condition during time of the study
- Storage condition of test material: ambient room temperature
- Other: Source: Glyco Inc.

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
- 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 (e.g. ad libitum): ad libitum (NIH 07 Open Diet, Zeigler Bros., Inc., Gardners, PA)
- Water (e.g. ad libitum): 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

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

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 1/2 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, and the terminology was in accordance with the appended list. 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

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:

No mortality was observed during the study period.

Clinical signs:

other: No clinical signs were observed in treated animals. The "ruffled coat" and diarrhea noted among vehicle controls was attributable to the large volume of vehicle (corn oil) received by these animals.

Body weight:

other body weight observations

Remarks:

No treatment-related effects on body weights were observed.

Gross pathology:

At necropsy, no abnormalities were observed.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

CLP: not classified