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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across study

Justification for type of information:

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. See section 13 for the full read-across justification.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

EC Number:

939-529-5

Molecular formula:

not applicable, substance is a UVCB substance containing several constituents

IUPAC Name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, SPF breeding, Hoe:WISK(SPF71)
- Age at study initiation: 6 -7 weeks
- Weight at study initiation: 187 g +/- 7 g males, 180 g +/- 3 g females
- Fasting period before study: over night
- Housing: Macrolon cages (type 4)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: recommended

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

2000 mg/kg (limit dose)

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption

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 lethality

Clinical signs:

yes (squatting posture, coat bristling)

Body weight:

not influenced

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Practically non-toxic via the oral route

Conclusions:

Based on the study results, sodium methyl cocoyl taurate (SMCT) is practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification.

Executive summary:

The acute oral toxicity of sodium methyl cocoyl taurate (SMCT) was tested in 5 male and 5 female Sprague Dawley rats at a dose level of 2000 mg/kg body weight (limit test) according to OECD Guideline 401. The animals received the compound once as a 20% suspension in water as vehicle via gavage and the administration volume was 10 mL/kg body weight. The observation period following treatment lasted 14 days. Unspecific symptoms like hypoactivity, squatting posture and coat bristling was observed in all animals from 10 - 30 minutes up to 4 - 6 hours post application. No mortality occurred. From day 1 until the end of the observation period no symptoms of toxicity were observed. The development of body weight was not impaired. None of the animals showed macroscopically visible changes. Based on the study results, the median lethal dose (LD50) of SMCT is greater than 2000 mg/kg body weight in rats.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be practically non-toxic after oral administration with an acute oral LD50 greater than 2000 mg/kg body weight in the rat. Refer to section 13 for read-across justification.