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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 23, 2018 to February 9, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Amides, C18-unsatd., N-hydroxyethyl
Molecular formula:
No molecular formula available for this UVCB.
IUPAC Name:
Amides, C18-unsatd., N-hydroxyethyl
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Female rates were selected for the test because they are frequently more sensitive to the toxicity of test compound than males. The rats were housed individually in stainless steel cages in a temperature 66-77oF, humidity 30-70% and light controlled 12 hr/cycle room. Each animal were assigned test number which appeared on a cage card visible on the front of each cage. The rats were maintained according to the recommendations contained in National academy press 2011: "Guide for care and use of Laboratory animals". Purina Laboratory Rat Chow and water were available ad libitum. The rats were acclimated at least five days prior to treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All test animals were fasted overnight prior to dosing. The test substance, was warmed in a water bath prior to dosing and administered orally as an amber coloured liquid to fasted animals according to individual body weights. Dosage volumes were administered via a metal dosing cannula.
Doses:
An initial limit dose of 5000mg/kg was administered to one rat. Due to the absence of mortality in this rat, 2 additional rats received the same dose level; simultaneously. There were mortality in one of the 2 additional animals. Two more animals were dosed at the 5000mg/kg level to fulfil the study requirement. There was no mortality observed in the additional 2 animals.
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
A limit test is planned for the study. One rat was dosed at 5000mg/kg, if the rat dies the main test will be conducted starting at an appropriate dose level (usually 175mg/kg) to determine LD50. If the rat survives at 5000mg/kg, 2 additional rats will be dosed and if both survive the LD50 will be considered greater than the limit dose and the study will be terminated. (I.e. carried out to 14 days observation without dosing further rats). If one or both rats die. 2 additional rats will be dosed one at a time. Results will be evaluated. The LD50 is considered to be greater than 5000mg/kg if 3 or more animals survive. If the LD50 is determined to be less than 5000mg/kg, the main test is conducted.
Statistics:
At the end of the observation period the calculation of the LD50was conducted according to the agency’s developed software package (AOT425StatPgm).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died out of 5 animals tested.
Clinical signs:
Staining around anal area observed for one animal.
Body weight:
Body weights were obtained at study initiation and at 7 & 14 days post-administration
Gross pathology:
Staining around anal area observed for one animal. No ghross changes observed

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the study conditions, the LD50 for the test substance was determined to be >5000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, amides, C18-unsatd., N-hydroxyethyl, using the up-and-down procedure according to the OECD Guideline 425, in compliance with GLP. Five female Sprague-Dawley rats were randomly selected for an acute oral toxicity study. Fasted rats were given a single dose of the test substance warmed in a water bath prior to dosing and administered orally as an amber coloured liquid according to individual body weights. An initial limit dose of 5000 mg/kg was administered to one rat. Due to the absence of mortality in this rat, 2 additional rats received the same dose level simultaneously. There was mortality in one of the 2 additional animals. Two more animals were dosed at the 5000 mg/kg level to fulfil the study requirement. There was no mortality in the additional 2 animals. Under the study conditions, the LD50 for the test substance was determined to be >5000 mg/kg bw (Michael, 2018).