Registration Dossier

Administrative data

Description of key information

The substance is no classified as the acute oral returned a result LD50 = 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 February to 2 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Kyoeisha Chemical Co., Ltd
- Lot/Batch No. of test material: 6033175
- Expiration date of the lot/batch: 17 March 2019
- Purity test date: 3 October 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (Ambient). Containers were kept tightly closed in a dry, cool and well ventilated place, away from heat and sun light
- Stability under test conditions: Assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent/vehicle: Formed a homogenous suspension, acceptable for dosing, in corn oil. Stability not performed, assumed stable for the duration of the study

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Mixed with corn oil to form a homogenous suspension

FORM AS APPLIED IN THE TEST (if different from that of starting material) Mixed with corn oil to form a homogenous suspension
Species:
rat
Strain:
Wistar
Remarks:
RccHan : WIST
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes, nulliparous and non-pregnant
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: Minimum: 159.9g, Maximum: 182.2g
- Fasting period before study: Rats were fasted overnight prior to dosing and until three hours post-dose.
- Housing: Polypropylene rat cages covered with a stainless steel grid top. Autoclaved clean rice husk was used as bedding material. Wooden chew blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
- Water (e.g. ad libitum): UV sterilized water filtered through a Reverse Osmosis water filtration system.
- Acclimation period: 7 to 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 56 to 67%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through an automatic timer)

IN-LIFE DATES: From: To: 24 February 2018 to 2 April 2018
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 300 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight (set I and set II)
2000 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight (set III and set IV)
- Amount of vehicle (if gavage): 1.60 to 1.82 mL per animal based on a administered dose volume of 10 mL/kg body weight
- Justification for choice of vehicle: The test item was found to be insoluble in Reverse Osmosis (RO) water. It did however form a homogenous suspension in corn oil, therefore dose formulations were prepared using corn oil as the selected vehicle. The required quantities, 300 mg test item (for set I and set II) and 2000 mg (III and set IVfor set III and set IV) were mixed in corn oil (final volume made up to 10 mL). Gavage solutions were prepared freshly prior to dosing on all occasions.
- Lot/batch no. (if required): Not specified
- Purity: Not specified

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no toxicological information was available on the test item, in line with OECD 423 a starting dose of 300 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight was selected as the initial test dose.
Doses:
300 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight (set I and set II)
2000 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight (set III and set IV)
No. of animals per sex per dose:
6 females per dose (i.e. 3 females/set)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5-6 h post-administration on the day of dosing. Rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the rats were euthanised by carbon dioxide asphyxiation and were subjected to gross pathological examination, consisting of external examination and opening of the abdominal and thoracic cavities.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in rats treated with 300 or 2000 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight.
Clinical signs:
No clinical signs were observed in any rat treated with 300 or 2000 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight.
Body weight:
Normal gain in body weight was observed in all rats treated with 300 or 2000 mg N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide/kg body weight.
Gross pathology:
Necropsy (Macroscopic Findings)
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal visceral examination of terminally sacrificed rats did not reveal any abnormality

In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at dose levels used in the present study.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50 cut- off value) N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide in Wistar rats was found to be 5000 mg/kg body weight.

Based on the results of this study, the classification for N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017): Category 5 or Unclassified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance is no classified as the acute oral returned a result LD50 = 5000 mg/kg bw.

Based on the results of this study, the classification for N, N’-bis {6-[12-(hydroxy) octadecanoylamino] hexyl} decanediamide is as follows:

Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017): Category 5 or Unclassified