Registration Dossier
Registration Dossier
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EC number: 224-339-0 | CAS number: 4316-74-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye 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:
- 80-84 % sodium N-methylamino ethanesulfonate
- 6-8 % sodium methylimino-di-ethanesulfonate
- 4-6 % sodium hydroxyethanesulfonate
- 1-2 % sodium hydroxide
- 2-3 % sodium sulfate
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 7 d, 14 d and 21 d
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- other: all
- Score:
- >= 0 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 d, 14 d, 21 d
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Sodium N-methyltaurinate is shown to cause irreversible damage to the eye on New Zealand White rabbits.
- Executive summary:
The guideline study on eye irritation of sodium N-methyltaurinate was carried out according to OECD 405 using New Zealand White rabbits. The study reports that the application of 100 mg of the test substance on the eye with a residence time of 24 h results in permanent corneal opacity as well as inflammation of the iris and conjunctivae. These dysfunctions were not fully reversible within the observation period of 21 days. Thus, it can be concluded that sodium N-methyltaurinate is corrosive to the eyes and classified by eye damage category 1.
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