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EC number: 276-704-9 | CAS number: 72496-92-5
- 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 / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000, March
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Justification for type of information:
- Justification for read across is detailed in the report attached to the IUCLID section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Real Decree 363/1995 and Real Decree 1078/93
- Principles of method if other than guideline:
- Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
- GLP compliance:
- no
- Remarks:
- Centre Certificated ISO 9001 by National Accreditation Programme (certificate N. 98 - 1101)
Test material
- Reference substance name:
- Similar substance 01 of Acid Brown 194
- IUPAC Name:
- Similar substance 01 of Acid Brown 194
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized provider
- Weight: from 2.012 to 2.113 g
- Housing: inoxidable steel individual cage, Techiplast. Rabbit were maintained in cages for the total duration of the test
- Diet: daily 150 g of special fodder for experimental rabbit, by authorized provider
- Water: ad libitum, treated and filtrated
- Marking: tatoo on the upper side of ear
- Acclimatation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes: 15 prefiltered air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 regulated by timer
USED GENERAL MATERIALS:
Balance: COBOS D 6000-SX
Vinyl/latex gloves mono-used
Syringes: 1 mL of volume
Shaver: electric AESCULAP mod. Favorita II
Gauzes dressing: Melolin or equivalent authorized
Adhesive bandage
Bandage: hypoalergenic adhesive Fixomull Seretch or equivalent authorized
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 0.5 g of solid substance humidified with water for assuring a good contact to the skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observation at: 1, 24, 48 and 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area shaved: retro-scapular side in the area around the vertebral column (20 cm of length and 13 cm of height).
- Area of exposure: 6 cm^2
- Type of wrap if used: gauzed dressing closed by adhesive bandage, covered with adhesive hypoalergenic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: water or specific solvent
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
If reactions are not reversible until 72h, it could be necessary an observation period of a maximum 14 days
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Observation: in rabbits 1 and 2, at 72 h lesions were fully reversible, while rabbit 3 does not show any irritating effects.
Any other information on results incl. tables
Erythema and edema
Time of observation |
Rabbit 1 | Rabbit 2 | Rabbit 3 | ||||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | ||
1h | 1 | 1 | 1 | 1 | 0 | 0 | |
24h | 1 | 1 | 1 | 0 | 0 | 0 | |
48h | 1 | 1 | 1 | 0 | 0 | 0 | |
72h | 0 | 0 | 0 | 0 | 0 | 0 |
Media erythema: 0.44
Media edema: 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin irritant
- Executive summary:
The substance was tested for skin irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
All lesions observed were all completely reversible maximum in 72 hours and one animal does not show any irritating effects. The tested substance is not considered as skin irritant.
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