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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
Not observed.
Body weight:
No abnormalities 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.