Methyl (S)-(-)-lactate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1994-06-16 to 1994-06-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted on February 24, 1987

Deviations:

yes

Remarks:

, a slight deviation on the humidity levels, which sometimes exceeded the upper limit of 70% given in the guideline

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

propyl (2S)-2-hydroxypropanoate

EC Number:

611-025-7

Cas Number:

53651-69-7

Molecular formula:

C6H12O3

IUPAC Name:

propyl (2S)-2-hydroxypropanoate

Specific details on test material used for the study:

- Name of test material (as cited in study report): n-propyl lactate
- Analytical purity: 99.5%
- Lot/batch No.: 3
- Appearance: clear, colourless liquid
- Storage conditions: ambient

TREATMENT OF TEST MATERIAL PRIOR TO TESTING:
undiluted

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/CPB, Austerlitz, The Netherlands
- Age at study initiation: 5-6 weeks
- Housing: 5 animals/cage (stainless steel cages, fitted with wire-screen floor and front)
- Diet: standard laboratory diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 45 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 59-92.5
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no vehicle used

MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw

Doses:

2000 mg/kg bw

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: clinical symptoms were recorded once daily; body weights were measured on day 3, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, the abdomen and the thorax were examined

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 occurred.

Clinical signs:

other: The only clinical symptom observed was sluggishness 1 and 4 h post-treatment, in all rats.

Body weight:

other body weight observations

Remarks:

All animals gained weight during the 14-day observation period

Gross pathology:

No treatment-related gross alterations were observed.

Other findings:

No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Propyl (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 propyl (S)-lactate (purity 99.5%) as a single oral dose of 2000 mg/kg bw. The animals were observed for 14 days after the single exposure. No mortalities and no further signs of toxicity occurred. Therefore, the oral LD50 is greater than 2000 mg/kg bw, both in male and female rats.