Registration Dossier
Registration Dossier
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EC number: 267-291-6 | CAS number: 67828-72-2
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- acceptable restrictions, mostly due to reduced reporting in times before GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. Exposure of 1, 5 and 15 minutes was not done in this experiment
- GLP compliance:
- no
Test material
- Reference substance name:
- Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
- EC Number:
- 226-102-7
- EC Name:
- Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
- Cas Number:
- 5280-66-0
- Molecular formula:
- C18H11N2O6SClMn
- IUPAC Name:
- Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex
- Test material form:
- solid: nanoform
- Details on test material:
- - Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100%
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100%
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Breeder
- Weight at study initiation: female: 3.06 kg, male: 3.23 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 50 % aqueous solution, creamy - Duration of treatment / exposure:
- 20 hour(s)
- Observation period:
- 8 days
- Number of animals:
- 1 female, 1 male
- Details on study design:
- Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.
TEST SITE
- Area of exposure: dorsal
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: cotton lobe
SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: red compound residues
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Other effects:
- Red substance residues after 24 h. No abnormality and no red substance residues detected after 8 d.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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