Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid

Endpoint summary

Description of key information

The substance is not classified as the acute oral toxicity was found to be > = 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:

9 February to 27 March 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 materia: Kyoeisha Chemical Co., Ltd
- Lot/batch No.of test material: 6021874
- Expiration date of the lot/batch: 18 February 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 or sunlight
- Stability under test conditions: Assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent/vehicle: Homogenous formulation in corn oil, assumed stable for the duration of the study.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Homogenised in corn oil

Species:

rat

Strain:

Wistar

Remarks:

RccHan : WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 11 weeks,
- Weight at study initiation: Minimum: 155.3g - Maximum: 188.7g
- Fasting period before study: Overnight fasting prior to dosing and 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: 6 to 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 49 to 66%
- 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: 15 February 2018 to 27 March (Experimental start to Experimental completion)

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 300 mg/kg body weight (Set I and II) and 2000 mg/kg body weight (Set III and IV)
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: The test item was insoluble in Reverse Osmosis (RO) water and 0.5% (w/v) Carboxymethylcellulose (CMC) solution. It did however form a homogenous suspension in corn oil (Sigma Aldrich), therefore corn oil was selected as the vehicle.
- Lot/batch no. and purity not specifiedity:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In accordence with OECD 423, Annex 2c, as no information was available on the test item, the first set (set I) of three female rats was administered a single dose of 300 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight.

Doses:

300 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight (Set I and II)
2000 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight (Set III and IV)

No. of animals per sex per dose:

6 (3 females/set)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5-6 hours 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.
- Necropsy of survivors performed: yes, at the end of the 14 day observation period, all 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.
- Other examinations performed: The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.

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 any rat treated with 300 mg or 2000 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight.

Clinical signs:

No clinical signs were observed in anyall rats treated with 300 or 2000 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight.

Body weight:

Normal gain in body weight was observed in all rats treated with 300 or 2000 mg Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide/kg body weight.

Gross pathology:

Necropsy:
External: 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 the dose levels used in the present study.
 

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50 cut-off value) Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide in Wistar rats was found to be 5000 mg/kg body weight.

Based on the results of this study, the classification for Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] 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

Quality of whole database:

Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance is not classified as the acute oral toxicity was found to be > = 5000 mg/kg bw.