2-(N-ethylanilino)ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted by the Council on December 17, 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(N-ethylanilino)ethanol

EC Number:

202-160-9

EC Name:

2-(N-ethylanilino)ethanol

Cas Number:

92-50-2

Molecular formula:

C10H15NO

IUPAC Name:

2-(N-Ethylanilino)ethanol

Test material form:

liquid - solid: mixture of

Details on test material:

At room temperature, the substance can be either a primrose yellow solid or a liquid.

Specific details on test material used for the study:

Batch/Lot Number 18052904
Analysed Purity 99.47 %
Manufactured by Binhai Henglian Chemicals Co., Ltd.
Supplied to JRF by Aceto France SAS
Date of Manufacture May 29, 2018
Date of Expiry May 28, 2019
Other Characteristics Water solubility : 2000 mg/L
Appearance Primrose yellow solid/yellowish liquid
*At room temperature, the phase of the substance can be either solid or liquid
Storage Condition (at JRF) As per the instruction received from the Sponsor on storage
of the test item, the test item was stored :
Storage Temperature 0 – 30 °C, Away from light and humidity
Storage Container In original container as supplied by the Sponsor
Storage Location Test Item Control Office, JRF

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan: WIST

Sex:

female

Details on test animals or test system and environmental conditions:

Animals:
Species : Rat (Rattus norvegicus)
Strain : RccHan : WIST
Age/Weight at Dosing: 9 to 10 weeks, Weight (g) Minimum: 192.3, Maximum: 210.0
Source : Animal Breeding Facility, Jai Research Foundation
Total Number : Six females; Female rats were nulliparous and non-pregnant
Acclimatisation: 6 to 8 days
Caging : Polypropylene rat cages covered with stainless steel grid top with autoclaved clean rice husk as bedding material and wooden blocks provided as enrichment material.
Water Bottle : Each cage supplied with a polypropylene water bottle with a stainless steel nozzle.
Housing : Maximum three rats per cage
Room Sanitation: Daily rack was cleaned with cloth, floor of experimental procedure room was swept, all work tops and the floor were mopped with a disinfectant solution.
Animal Identification: Each rat was uniquely numbered on the tail using a tattoo machine on day 1 of acclimatisation.
Cage identification: Appropriate labels were attached to the cages indicating the study number, study code, test item code, set number, sex, dose, type of study, cage number and animal number.
Feed : Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
Water : UV sterilized water filtered through Reverse Osmosis water filtration system.
Environmental Conditions:
Animal Room : DCR 208, Department of Toxicology
Temperature : 20 to 23°C
Relative Humidity: 64 to 66%
Air Changes : Minimum 15 air changes/hour
Photoperiod : The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through automatic timer)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Individual dose volume was adjusted according to body weight, dose level and density (1049.4 mg/mL). All rats were dosed by oral gavage (day 0) using a metal cannula attached to a BD 1 mL disposable syringe which was graduated up to 1 mL. Rats were fasted overnight prior to dosing until three hours post-dosing.
A first set of three female rats were given a single dose of 2000 mg 2-(N-ethylanilino) ethanol/kg body weight. No mortality was observed at this dose level, so second set of three female rats were treated at the same dose level of 2000 mg 2-(N-ethylanilino) ethanol/kg body weight. No mortality was observed at this dose level hence the endpoint was achieved and further testing was not required.

Doses:

2000 mg kg bw.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Observations: The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5 h post-administration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. 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.
Necropsy: At the end of the 14 days 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.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality.

Clinical signs:

No clinical signs

Body weight:

Normal gain in body weight was observed in all rats

Gross pathology:

External examination of terminally sacrificed rats did not reveal any abnormality.

Other findings:

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 level used in the present study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of 2-(N-ethylanilino) ethanol in Wistar rats is > 2000 mg/kg body weight. Since no mortality or any visible sub-lethal effects occurred in six animals tested, there is no reason to expect significant mortality between 2000 and 5000 mg/kg body weight. For reasons of animal welfare concern, testing of animals in GHS Category 5 ranges (2000-5000 mg/kg) is discouraged and should only be considered when there is a strong likelihood that results of such a test have a direct relevance for protecting human or animal health or the environment.