3-[(2-hydroxyethyl)amino]propionamide

Endpoint summary

Description of key information

In order to test the acute oral toxicity of the test substance ACMEO an OECD 401 Study is available

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:

1993-03-08 to 1993-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study is an OECD 401 study under GLP and well documented

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Spraque Sawley strain rats. Weight at start:
TEST ANIMALS
- Source: supplied by Charles River (UK) Ltd.
- Age at study initiation: approx. five to eight weeks
- Weight at study initiation: males 156-188 g, females 142-154 g
- Fasting period before study: overnight fast immediately before dosing
- Housing: in groups of five by sex in solid polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: minimum 5 day period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 42- 54 %
- Air changes (per hr): approx. 15/ hr
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

all animals (5/sex) were dosed once only with the undiluted test substance by oral gavage using a metal cannula. The volume administered to each animal was calculated according to its fasted body weight at the time of dosing (Specific gravity: 1.129; dose volume 1.78 mL/kg)

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5/ sex /dose

Control animals:

no

Details on study design:

A range finding study was performed with one male and one female at a dose of 2000 mg/kg body weight to establish a dosing regime. The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequent once daily for 5 days.
Based on the results of the range finding study in the main study all animals (5/sex) were dosed once only by gavage at a dose of 2000 mg/kg body weight using a metal cannula. The volume administered to each animal was calculated according to its fasted body weight at the time of dosing. The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequent once daily for 14 days. Individual bodyweights were recorded prior to dosing on day 0 and on Days 7 and 14. At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. No tissues were retained.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of systemic toxicity were noted during the study

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD 50) of the test material ACMEO in the spraque Dawley strain rat was found to be greater than 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of ACMEO was tested in 10 Spraque Dawley strain rat (5/sex) according to OECD test guideline 401. The test substance was applied once by oral gavage undiluted at a dose level of 2000 mg/kg body weight (limit test). Symptoms were recorded dayily and the animals were weight once a week upon an observation period of 14 days. No lethality occurred during the subsequent observation period. The animals killed at the end of the observation period showed no macroscopically visible changes.

Based on the study results the acute oral median lethal dose (LD 50) of the test material ACMEO in the spraque Dawley strain rat was found to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is an OECD 401 sutdy performed under GLP and well documented. Reliability is1

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

Based on the study results the acute oral median lethal dose (LD 50) of the test material ACMEO in the spraque Dawley strain rat was found to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the result from the OECD 401 study, the test substance as not to be classified as acute oral toxic according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.