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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw of the test substance by stomach intubation. The animals were observed for 14 d.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
EC Number:
700-972-2
Molecular formula:
C22H43NO3
IUPAC Name:
(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 150-250 g
- Fasting period before study: 24 h
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow (ad libitum)
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Six adult SD rats per dose group were given the test substance by stomach intubation.
Doses:
0, 5000, 10000 and 20000 mg/kg.
No. of animals per sex per dose:
Males: 6/dose/group
Control animals:
not specified
Details on study design:
Male SD rats were fasted for 24 h and then administered single doses of the test substance by stomach intubation followed by 14 d of observation period.
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 10 000 mg/kg bw
Based on:
test mat.
Mortality:
Number of dead/number dosed:
- No mortality occured at lowest dose of 5000 mg/kg, i.e., 0/6
- 50% mortality was observed In the mid dose group of 10000 mg/kg, i.e., 3/6
- Almost all animals died in the highest dose group of 20000 mg/kg, i.e., 5/6.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, C18-unsatd. DEA, in Sprague Dawley rats. Groups of 6 males were administered 0, 5000, 10000 and 20000 mg/kg bw by stomach intubation and observed for 14 d. Approximately 50% mortality occurred at the mid dose. Under the study conditions, the oral LD50 in rats was found to be 10000 mg/kg bw (Casey, 1976).