N,N-Di-(2-Ethylhexyl)-amino Isostearamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 June 2020 - 07 July 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-Di-(2-Ethylhexyl)-amino Isostearamide

EC Number:

848-720-1

Cas Number:

1616494-50-8

Molecular formula:

C34H69NO

IUPAC Name:

N,N-Di-(2-Ethylhexyl)-amino Isostearamide

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Ltd.
- Weight at study initiation: 162 - 168 g
- Housing: 1 or 4 per cage in polycarbonate cages
- Diet: standard rodent diet (Teklad 2014C Diet),); ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The appropriate dose volume of the test item was administered to each rat by oral gavage using a plastic syringe and plastic catheter.

Doses:

300 mg/kg and 2000mg/kg

No. of animals per sex per dose:

Two single animals were treated as follows:
Dose level (mg/kg) Concentration (mg/mL) Dose volume (mL/kg) Number of rats (Female)
300 30 10 1
2000 200 10 1
In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose level (mg/kg) Concentration (mg/mL) Dose volume (mL/kg) Number of rats (Female)
2000 200 10 4
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: before administration, on day 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: There were no clinical signs of reaction to treatment throughout the study.

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Any other information on results incl. tables

There were no deaths during the study.

There were no clinical signs of reaction to treatment throughout the study.

All animals were considered to have achieved satisfactory body weight gains throughout the

study.

No abnormalities were noted in any animal at the macroscopic examination at study

termination on Day 15

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

No mortality observed at 2000mg/kg hence unclassified

Conclusions:

The acute median lethal oral dose (LD50) to rats of DE11657 was demonstrated to be greater than 2000 mg/kg body weight.

Executive summary:

The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg body weight.