Registration Dossier
Registration Dossier
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EC number: 224-339-0 | CAS number: 4316-74-9
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Sodium N-methyltaurinate
- EC Number:
- 224-339-0
- EC Name:
- Sodium N-methyltaurinate
- Cas Number:
- 4316-74-9
- Molecular formula:
- C3H9NO3S.Na
- IUPAC Name:
- sodium N-methyltaurinate
Constituent 1
- 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
Test animals
- 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.
Administration / exposure
- 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.
Results and discussion
Effect levelsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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