Butyl (S)-2-hydroxypropionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1989 to 1989-11-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in Feb 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl (S)-2-hydroxypropionate

EC Number:

252-036-3

EC Name:

Butyl (S)-2-hydroxypropionate

Cas Number:

34451-19-9

Molecular formula:

C7H14O3

IUPAC Name:

butyl 2-hydroxypropanoate

Specific details on test material used for the study:

- Name used in the study report: (S (-) - Butyl lactate)
- Trade Name: Purasolv BL
- Batch No.: BU 021F
- Purity: min. 97%
- Appearance: clear, colourless liquid
- CAS No.: CAS: 138-22-7 (although this is the CAS number for butyl lactate of unspecified stereochemistry, the substance is clearly identified as the S-enatiomer)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Center for Laboratory Animals 'Charles River Wiga GmbH, Sulzfeld, F.R., Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 161-188 g for males and 126-139 g for females
- Number of animals: 5 females, 5 males
- Housing: in groups of 5 animals, stainless cages with wire-screen bottom
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

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

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 mL/kg bw
- Justification for choice of vehicle: No data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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. At the end of the observation period, the rats were killed for macroscopic examination. No microscopic examination was performed.

Statistics:

No data

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:

No mortality was observed.

Clinical signs:

other: At 1, 4 and 24 h after treatment all animals showed moderate piloerection, which was not observed 48 h afterwards. At 4 h post treatment all animals showed moderate signs of diarrhoea, which were not observed 24 h after treatment.

Gross pathology:

No treatment-related gross lesions were observed.

Other findings:

No other findings

Any other information on results incl. tables

Table 1: Summary of dose applied, mortality and mean body weights on day 0, 3, 7 and 14 after exposure to butyl-S-lactate:

Sex	Test concentration [mg/kg]	Mean body weight [g] on day				Mortality per 5 animals
		0	3	7	14
Male	2000	174	324	238	267	0/5
Female	2000	131	156	163	172	0/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Butyl-S-lactate is not acutely toxic when administered to rats by gavage, at a single dose of 2000 mg/kg bw. The LD50 is greater than 2000 mg/kg bw for both sexes.

Executive summary:

In an acute oral toxicity study conducted according to OECD guideline 401, groups of Wistar rats (5/sex) were given butyl-S-lactate (min. 97 % purity) as a single oral dose of 2000 mg/kg bw in maize oil. The animals were observed for 14 days after the single exposure. No mortalities occurred. Therefore, the oral LD50 value is greater than 2000 mg/kg bw, both in male and female rats.