Sodium 2-[(1-oxododecyl)amino]ethanesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Safety Assessment of Alkyl Taurate Amides and Taurate Salts as Used in Cosmetics

Author:

Cosmetic Ingredient Review Expert Panel

Year:

2016

Bibliographic source:

Cosmetic Ingredient Review Expert Panel, 2016

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study of sodium N-methyltaurinate was performed in Rat

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-methyltaurinate

EC Number:

224-339-0

EC Name:

Sodium N-methyltaurinate

Cas Number:

4316-74-9

Molecular formula:

C3H8NNaO3S

IUPAC Name:

Sodium 2-(methylamino)ethane-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report):sodium N-methyltaurinate
- Molecular formula :C3H8NNaO3S
- Molecular weight :161.156g/mole
- Substance type:organic
- Physical state:Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report):sodium N-methyltaurinate
- Molecular formula :C3H8NNaO3S
- Molecular weight :161.156g/mole
- Substance type:organic
- Physical state:No data available
-Purity:No data available
- Impurities (identity and concentrations):No data available

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

No data available

Doses:

4000, 4500, 4750, 5000, 6300 mg/kg

No. of animals per sex per dose:

No data available

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?)No data available
- Frequency of observations and weighing:No data available
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality and Gross pathology were observed

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 4 670 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed

Clinical signs:

other: No data available

Gross pathology:

Necropsies showed unspecified changes to the intestines/ gastrointestinal tract, especially in the rats that died before the end of the experiment.

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be >4670mg/kg body weight. When wistar rats was treated with sodium N-methyltaurinate (4316-74-9) orally.

Executive summary:

Acute oral toxicity study was done in wistar rats usingsodium N-methyltaurinate (4316-74-9).test material in dose concentration 4000, 4500, 4750, 5000, 6300 mg/kg in water given by oral route. No mortality was observed at dose 4670mg/kg bw but Necropsies showed unspecified changes to the intestines/ gastrointestinal tract, especially in the rats that died before the end of the experiment HenceLD50 was considered to be >4670mg/kgbody weight. When wistar rats was treated with sodium N-methyltaurinate (4316-74-9)orally.