Registration Dossier
Registration Dossier
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EC number: 224-339-0 | CAS number: 4316-74-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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:
- Name of test material (as cited in study report): N-methylamino-ethansufonsaures Natrium (German)/sodium N-methylamino ethanesulfonate
Physical state: dehydrated
Composition:
- 76-84 % sodium N-methylamino ethanesulfonate
- 6-8 % sodium methylimino-di-ethanesulfonate
- 4-6 % sodium hydroxyethanesulfonate
- 1-2 % sodium hydroxide
- 1-3 % sodium sulfate
- 0-0.5 % sodium sulfite
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 0.5-1 h, 24 h, 48 h, 72 h, 7 d, 14 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min, 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30-60 min to 7 days
- Score:
- >= 1 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of mild irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Sodium N-methyltaurinate is shown to be corrosive to the skin of New Zealand White rabbits.
- Executive summary:
The guideline study on skin irritation / corrosion of sodium N-methyltaurinate was conducted according to OECD 404 using New Zealand White rabbits. The study reports that the application of 500 mg sodium N-methyltaurinate on shaved skin (semiocclusive coverage) with a residence time of 4 h results in edema and erythema. Therefore, it can be concluded that sodium N-methyltaurinate is corrosive to the skin and has to be classified as skin corrosive category 1C.
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