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EC number: 256-050-0 | CAS number: 43035-18-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
- Deviations:
- no
- Principles of method if other than guideline:
- As compared to current guidelines deviations are: 24 h treatment and occlusive coverage, instead of 4 h treatment and semi-occlusive coverage. Mean scores for each animal were claculated from the readings 0, 24, and 48 h after the end of treatment.
Since test conditions were more stringent than required by OECD TG 404 test results are considered adequate to fulfill the endpoint requirements. - GLP compliance:
- no
- Remarks:
- not established at that time
Test material
- Reference substance name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- EC Number:
- 256-050-0
- EC Name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- Cas Number:
- 43035-18-3
- Molecular formula:
- C32H26N4O7S.1/2Ca
- IUPAC Name:
- calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 1.5 - 2.5 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped, partially scarified
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg pasted with 0.7 ml physiol. saline. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after end of exposure
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 1, 2, 3, 4, 5, 6 each
- Time point:
- other: mean of the 0, 24 and 48 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect
- Remarks on result:
- other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
- Irritation parameter:
- edema score
- Basis:
- animal: # 1,2,3,5,6 each
- Time point:
- other: mean of the 0, 24 and 48 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect
- Remarks on result:
- other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: mean of the 0, 24 and 48 h reading
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
- Irritant / corrosive response data:
- - Edema score for animal #1,2,3,4,5,6 immediately after removal of the test item (0 h): 0,0,0,1,0,0 and after 24 h: 0,0,0,1,0,0, and after 48 h: 0,0,0,0,0,0 (intact skin).
- At the scarified skin two animals showed erythema (score 1) 24 h after end of exposure, 3 animals showed edema at the end of the exposure period (score 1) and 1 animal showed edema score 1 at 24 h after end of exposure, these effects were completely reversible at the reading 48 h after end of exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to skin. This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
1/6 animals showed a score of 1 for edema in the 24 h reading. This effect was completely reversible within 48 h after removal of the test item. - Executive summary:
The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Only slight effects could be observed (1/6 animals showed a edema score of 1 in the 24 h reading, which was completely reversible in the 48 h reading.
No erythema effects could be observed in any animal.Therefore, it is concluded that the test item is not irritating to skin.
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