Amines, C12-18-alkyl, reaction products with acrylic acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted prior to the implementation of current testing guideline and GLP; nevertheless, the test conduct in principle was similar to the OECD TG 401 and thus, acceptable. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

EC Number:

239-032-7

EC Name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

Cas Number:

14960-06-6

IUPAC Name:

Sodium Lauriminodipropionate

Test material form:

other: liquid

Details on test material:

- Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material

Specific details on test material used for the study:

Form: aqueous solution
The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Weight at study initiation: approx. 130 g
- Fasting period before study: 16 hours (food withdraw)
- Housing: individually in stock cages
- Diet: Standard laboratory rat diet (Rockland Rat Diet, Rockland Farms, New City, New York), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

15400, 23100, 34600 and 51900 mg/kg bw (calculated doses of the undiluted test material)

No. of animals per sex per dose:

2/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: particular attention was given to observation for mortalities and clinical symptoms during the first 4 hours following treatment.
- Necropsy of survivors performed: not specified

Statistics:

The LD50 was calculated using the techniques of Weil CS (Tables for convenient calculation of median-effective dose (LD50 or ED50) and instructions in their use. Biometrics 8: 249-263, 1952), Thompson WR (Use of moving averages and interpolation to estimate median-effective dose. Bact Rev Nov 1947), and Thompson & Weil (On the construction of tables for moving average interpolation. Biometrics, March 1952).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

31 300 mg/kg bw

Based on:

test mat.

Mortality:

100% (4/4) mortality was observed at 51900 mg/kg bw
50% (2/4) mortality was observed at 34600 mg/kg bw
25% (1/4) mortality was observed at 23100 mg/kg bw
no mortality occurred at 15400 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

For assessment of the acute oral toxicity, sodium lauriminodipropionate as a 10% active ingredient solution in water, was administered by single gavage to rats, at dose levels of 15400, 23100, 34600 and 51900 mg/kg bw. Each test group comprised 2 male and 2 female animals, observed for 14 days. The testing method in principle was similar to the OECD TG 401.

The following results were obtained:

- 100% (4/4) mortality was observed at 51900 mg/kg bw;

- 50% (2/4) mortality was observed at 34600 mg/kg bw;

- 25% (1/4) mortality was observed at 23100 mg/kg bw;

- No mortality occurred at 15400 mg/kg bw.

The LD50 was therefore calculated to be 31300 mg/kg bw.