L-Alanine, N-coco acyl derivs., sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-Alanine, N-coco acyl derivs., sodium salts

EC Number:

290-478-9

EC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Cas Number:

90170-45-9

Molecular formula:

RHNNaO3

IUPAC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

Name: Sodium Cocoyl-L-Alaninate (ACS-12)
Lot No.: 051020-2
Description: liquid
Purity: 30% (as an active ingredient)
Storage conditions: at room temperature, light shielding

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation: 124 - 165 g
- Fasting period before study: approximately 18 hours before administration and 2 hours post administration
- Housing: individually in metallic bracket cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

3.0 g of test article was weighed into a glass beaker and added with vehicle to prepare a 10 % (w/v) solution using a magnetic stirrer. The test article preparation was conducted immediately before use.
Dose volume: 20 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 m / 3 f

Control animals:

no

Details on study design:

Mortality: Number of deaths was observed once daily.
Clinical signs: The acute toxicity symptoms were observed until 2 hours after administration. Clinical signs of all surviving animals were observed before treatment and approximately 6 hours after administration on Day 1, and once daily in the morning from Day 2 to Day 15.
Body weight changes: All animals were weighed on Day 1, 2, 4, 7, 11 and 15.
Necropsy: All surviving animals were sacrificed on Day 15 and macroscopic examination were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the study period

Clinical signs:

Diarrhea was observed in one male at approximately 6 hours after administration. This sign disappeared on the next day. There were no other abnormal clinical signs during the study period.

Body weight:

All animals showed body weight gain during the study period.

Gross pathology:

All animals showed no abnormal findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 is considered to be greater than 2000 mg/kg.

Executive summary:

This study was conducted to determine the acute oral toxicity of a test article Sodium Cocoyl-L-Alaninate. The test article was single administered to rats at a dosage of 2000 mg/kg. No abnormalities were observed by administration, and the LD50 is considered to be greater than 2000 mg/kg.