Registration Dossier
Registration Dossier
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EC number: 418-240-3 | CAS number: 74401-04-0 N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
- EC Number:
- 418-240-3
- EC Name:
- N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
- Cas Number:
- 74401-04-0
- Molecular formula:
- C16H17NO5S
- IUPAC Name:
- 4-[2-(4-formylphenyl)ethenyl]-1-methylpyridin-1-ium methyl sulfate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- The substance was moistened with 0.5 ml of distilled water.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks:
- Max. value at end of the observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 7 days.
- Other effects:
- Incidents of desquamation were noted at all treated skin sites at the 7-day observation. No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: The test substance is not classified as skin irritant or skin corrosive according to the CLP Regulation EC No. 1272/2008.
- Conclusions:
- Non-skin irritant
- Executive summary:
The skin irritation/corrosion potential of the test substance was evaluated in vivo in New Zealand White rabbits in a semiocclusive test according to the EU method B.4 (92/69/EEC) and in compliance with GLP. All the three animals showed very slight erythema and desquamation but no signs of oedema. The changes, however, were fully reseversible and no corrosive effects were observed.
The substance is considered as a non-skin irritant
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