Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1989 - November 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-

EC Number:

606-097-1

Cas Number:

186817-80-1

Molecular formula:

C11H22O3

IUPAC Name:

Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-

Constituent 2

Reference substance name:

2-ethylhexyl-S-lactate

IUPAC Name:

2-ethylhexyl-S-lactate

Details on test material:

Batch no.: EHL-002-3
Purity: 98.6 %

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 "Charles River Wiga GmbH", Sulzfeld, F.R. Germany
- Age at study initiation: young adult (7 weeks old)
- Weight at study initiation: 170 to 188 g for males and 134 to 151 g for females
- Fasting period before study: overnight
- Housing: The rats were housed in groups of five animals, males and females separated. They were kept in stainless cages with wire-screen bottom and front.
- Diet (e.g. ad libitum): the Institute's cereal-based, open-formula basal diet for rats, ad libitum
- Water (e.g. ad libitum): tap water was freely available at alle times by means of an automatic watering system
- Acclimation period: 2 weeks

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

IN-LIFE DATES: September 19, 1989 to October 16, 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage): 10.0 ml/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- 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. Individual body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

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

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred, see Table 1.

Clinical signs:

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

Gross pathology:

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

Any other information on results incl. tables

Table 1. Acute oral toxicity of "S(-)-2-ethyl hexyl lactate" in groups of five male and five female rats. Dose applied, mean body weights and mortality figures.

	Test substance (mg/kg)	Mean body weight (g) on day				Mortality (per 5 animals)
Sex		0	3	7	14
Males	2000	179	213	244	272	0/5
Females	2000	142	167	179	183	0/5

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of 2-ethylhexyl-S-lactate is clearly less than the limit for classification as harmful.

Executive summary:

In an acute oral toxicity study (OECD guideline 401, limit test), groups of five male and five female, 7 weeks old Wistar outbred rats, fasted overnight, were given a single oral dose of 2-ethylhexyl-S-lactate in maize oil at a dose of 2000 mg/kg bw and observed for 14 days. No mortality occurred.

The oral LD₅₀ in males and females was > 2000 mg/kg bw. 2-Ethylhexyl-S-lactate is of low toxicity based on absence of mortality at the limit dose in males and females.