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EC number: 264-129-6 | CAS number: 63405-85-6
- 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
- Study period:
- Study completion date - 14 August 1978.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
- EC Number:
- 264-129-6
- EC Name:
- Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
- Cas Number:
- 63405-85-6
- Molecular formula:
- C20H18N4O5S.Na
- IUPAC Name:
- sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Name: FAT 20004/D
Purity: 61 %
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1°C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- Up to 7 d
- Number of animals:
- six animals (Three males and three females)
- Details on study design:
- TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.
Score for skin irritation in rabbits
Erythema and eschar formation
No erythema............................................................ 0
Very slight erythema (barely perceptible).................... 1
Well defined erythema.............................................. 2
Moderate to severe erythema.................................... 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ........4
Total possible erythema score 4
Edema formation
No edema................................................................ 0
Very slight edema (barely perceptible)........................ 1
Slight edema (edges of area well defined by definite raising)..... 2
Moderate edema (raised approximately 1 mm)........................ 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) ........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Calculation of the primary skin irritation index:
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
Time after exposure h | mean reaction score of 6 rabbits | ||||
erythema | edema | ||||
intact skin | abraded skin | intact skin | abraded skin | ||
24 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
subtotal | 0 | 0 | 0 | 0 | |
total | 0 + 0 + 0 + 0 = 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24-hours exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.
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