Registration Dossier
Registration Dossier
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EC number: 276-649-0 | CAS number: 72403-66-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive 92/69/EC, B.4
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 423-100-1
- EC Name:
- -
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: unknown
- Stability under storage conditions: unknown
- Stability under test conditions: unknown
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: vehicle is bi-distilled Water. Solubility of the test substance in water is 49.8 g/L pH 8.4 and T = 20°C.
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable): unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dilution with bi-distilled water.
- Preliminary purification step (if any): unknown
- Preparation of a nanomaterial dispersion (incl. dilution): unknown
- Final dilution of a dissolved solid, stock liquid or gel: unknown
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Unknown
- Number of animals:
- 3 Animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Max. duration: 0 d; Max. value at the end of observation period: 0 (related to all animals)
- Other effects:
- COLORATION:
Light-green staining of the treated skin was noted throughout the whole observation period. No oedema and no erythema was observed.
- MORTALITY/CLINICAL SIGNS: No mortality and no clinical signs observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not skin irritant
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