Ethyl (S)-2-hydroxypropionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-28 to 1995-08-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl (S)-2-hydroxypropionate

EC Number:

211-694-1

EC Name:

Ethyl (S)-2-hydroxypropionate

Cas Number:

687-47-8

Molecular formula:

C5H10O3

IUPAC Name:

ethyl 2-hydroxypropanoate

Specific details on test material used for the study:

- Name of test material used in the report: ethyl lactate
- CAS number: 687-47-8 (confirmed by sponsor)
- Trade name: Purasolv EL
- Batch number: EA 0188F
- Appearance: liquid
- Purity: 99.5%
- Storage: at room temperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals Çharles River Wiga GmbH", Sulzfeld, F.R. Germany.
- Age at study initiation: 5 weeks.
- Weight at study initiation: males: 139-158 g; females: 126-141 g.
- Fasting period before study: overnight.
- Housing: Groups of five animals, males and females separated in stainless cages either wire-screen bottom and front.
- Diet (e.g. ad libitum): The Institute's cereal-based, open-formula basal diet for rats was fed to the animals ad libitum during the quarantine and study periods except for fasting prior to dosing.
- Water (e.g. ad libitum): Tap water was freely available at all times by means of an automatic watering system.
- Acclimation period: The rats were kept under the environmental conditions of the Institute's animal house for an acclimatization period of about 1 week prior to the test.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C.
- Humidity (%): 30-70%.
- Air changes (per hr): about 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was diluted with water in a concentration of 20% (w/v). The test dilution was given by gavage, in one single dose of 10 mL/kg body weight to five male and five female rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

A preliminary study was carried out to find the general level of acute toxicity for the test substance.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed frequently for signs of intoxication during the first 4 post-treatment hours and later on, at least once daily, throughout an observation period of 14 days. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: At the end of the observation period, the rats were killed with carbon dioxide for macroscopic examination.

Statistics:

Since no mortality occurred a LD50 could not be calculated; a LD50 exceeding 2000 mg/kg bw was given as a result.

Results and discussion

Preliminary study:

A prelimary study was carried out to find the general level of acute toxicity of the test substance; data of this preliminary study were not presented in the report.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occcurred

Clinical signs:

other: At 1, 4 and 24 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 48 hours after treatment and thereafter.

Gross pathology:

Macroscopic examination at the end of the observation period did not reveal any treatment-related gross alteration.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

In an acute oral toxicity study in rats conducted according to OECD Test Guideline 401, no mortality occurred at the limit dose of 2000 mg/kg bw. Based on the results and in accordance with OECD Guideline 401, the oral LD50 was determined to be greater than 2000 mg/kg bw in both male and female rats.

Executive summary:

In an acute oral toxicity study conducted according to OECD Test Guideline 401, groups of Wistar rats (n= 5/sex) were given a single oral dose of Ethyl (S)-lactate (purity: 99.5%) in water at a dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study. At 1, 4 and 24 hours after treatment all animals showed moderate signs of piloerection. These signs of intoxication were not observed 48 hours after treatment and thereafter. All animals gained weight after 3 days and thereafter. At necropsy, no treatment-related macroscopic findings were observed in any animal.

Based on the results the LD50 value was determined to be greater than 2000 mg/kg bw. Therefore, classification for acute oral toxicity according to the CLP Regulation 1272/2008 is not warranted.