2-Propenamide, N-(2-hydroxyethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 May 2000 to 30 June 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-hydroxyethyl)prop-2-enamide

EC Number:

700-169-7

Cas Number:

7646-67-5

Molecular formula:

C5H9NO2

IUPAC Name:

N-(2-hydroxyethyl)prop-2-enamide

Specific details on test material used for the study:

Lot number: MDB-329
Purity: >99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 94 to 108 g.
- Fasting period before study: Access to food was only prevented overnight prior to and for approximately 4 hours after dosing.
- Housing: The rats were housed in groups of three, of the same sex, in metal cages. The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays.
- Diet: Special diet services RMI E; SQC expanded pellet, ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed immediately after dosing and at approximately hourly intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Clinical signs were confined to piloerection, notable in all rats at both dosages. There were no signs of response to treatment and piloerection had resolved in all instances within 48 hours of dosing.

Gross pathology:

No abnormalities were revealed at the macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of HEAA to rat, according to OECD Guideline 423, under GLP.

The acute lethal oral dose to rats of HEAA was demonstrated to be greater than 2000 mg/kg bodyweight.