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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The guideline study on acute oral toxicity of sodium N-methyltaurinate was conducted according to OECD 401 using Sprague-Dawley rats. LD0 and NOAEL of sodium N-methyltaurinate are >= 2500 mg/kg bw. The test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies. This result is supported by another provided OECD 401 guideline study, which reports the acute oral toxicity of sodium N-methyltaurinate on Wistar rats. The tested LD50 in this study is >= 4670 mg/kg bw. These findings reflect the low toxicity of sodium N-methyltaurinate. In conclusion, the substance does not need to be classified for oral toxicity according to GHS criteria.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
This study was carried out according to the OECD Guidelines for the testing of Chemical No. 401 and the EEC Guidelines: Official Journal of European Communities L 251: Acute toxicity (oral) and Annex V, B.1.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Na-Methyltaurid
Supplier: Leuna-Werke AG
Batch No.: MM 90100512E
Assay: Sodium methyltauride 46.4 %; monomethylamine 0.013 %; solid material (total) 49.1 %
Substance type: aqueous solution
Physical state: liquid
Stability: During the course of the study
Storage conditions: Room temperature
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Number of animals: 20 (10 males, 10 females)
Identification of animals: By coloured marks
Duration of adaption: At least 5 days
Initial weight of animals:157-187 g; age: appr. 40-60 days. Animals were randomized before use.
Route of administration:
oral: gavage
Vehicle:
other: 0.8% aqueous hydroxypropyl-methyl-cellulose gel
Doses:
Single oral administration
2 dose-levels of 5 males and 5 females, 2000 mg/kg and 2500 mg/kg bw.
Dose-levels refer to Sodium methyltauride (total solid material)
Volume of application: 20 mL/kg bw. for each group
Dose interval factor: 1.25
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Standardized diet for rats and mice ALTROMIN 1324 (ALTROMIN GmbH, Lage/Lippe, Germany) served as food. Feeding was discontinued ca. 16 hours before administration. Only tap water was then offered ad lib. Observations were performed immediately, 5 min, 15 min, 30 min, 60 min, 3 h, 6 h, 24 h after administration. All animals were observed for a period of 14 days.
Sex:
male/female
Dose descriptor:
LD0
Remarks:
(24 h)
Effect level:
>= 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of intolerance reactions. Autopsy: no pathological findings
Sex:
male/female
Dose descriptor:
LD0
Remarks:
(14 days)
Effect level:
>= 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of intolerance reactions. Autopsy: no pathological findings
Sex:
male/female
Dose descriptor:
other: NOAEL
Effect level:
>= 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of intolerance reactions. Autopsy: no pathological findings
Mortality:
No mortality was reported for the total test duration (14 days).
Clinical signs:
other: No signs of intolerance reactions. Autopsy of surviving animals (sacrificed) (male and female): No pathological findings.
Interpretation of results:
GHS criteria not met
Conclusions:
LD0 and NOAELof sodium N-methyltaurinate are >= 2500 mg/kg bw. Test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies.
Executive summary:

The guideline study on acute toxicity (oral) of sodium N-methyltaurinate was carried out according to OECD 401 using Sprague-Dawley rats. LD0 and NOAELof sodium N-methyltaurinate are >=  2500 mg/kg bw. Test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies. In conclusion, the substance does not need to be classified for oral toxicity according to GHS criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
2 500 mg/kg bw
Quality of whole database:
The study has been done according to OECD 401.

Additional information

Justification for classification or non-classification

For sodium N-methyltaurinate the LD0 and NOAEL are >= 2500 mg/kg bw. For classification according to EU Regulation No. 1272/2008 an LD50 of equal or less than 2000 mg/kg bw is required. Therefore, sodium N-methyltaurinate does not need to be classified for oral toxicity.