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A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
EC number: 402-850-1 | CAS number: - NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29. Sep. to 13. Oct. 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
- EC Number:
- 402-850-1
- EC Name:
- A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- trichromium(3+) nonasodium 6-[2-(2-amino-4-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(2-amino-6-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(4-amino-2-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate tris(6-{2-[(1Z)-2-hydroxy-1-(phenylcarbamoyl)prop-1-en-1-yl]diazen-1-yl}-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madörin AG, 4414 Füllinsdorf, CH
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.5 to 2.6 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet: ad libitum; pelleted standard Kliba 341, batch 30/87 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: 4 days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount: 0.1 g per animal
- Concentration: undiluted; solid - Duration of treatment / exposure:
- One single application
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Males: 1
Females: 2
Total: 3 - Details on study design:
- TREATMENT
- The test item was placed in the conjunctival sacs of the left eye of each animal after gently pulling the lower lid away from the eye ball. The lids were then gently held together for about 1 second to prevent loss of the test item.
REMOVAL OF TEST SUBSTANCE :
- Washing: no washing
TOOL USED TO ASSESS SCORE:
- Eye examinations were made with a slit-lamp 30 SL (C. Zelss AG, Zürich, CH) and a "Varta Cliptrix" diagnostic-lamp (A. Riegger, Basel, CH)
SCORING SYSTEM:
- Irritation scores of each animal at 1, 24, 48 and 72 hours and 7 and 14 days were measured.
- The corrosive properties of the test item and the colour of the treated eye were described and recorded.
- The following numerical system was used to grade the eye lesions:
CORNEAL IRRITATION: opacity; degree of density (densest area used for assessment)
0 No ulceration or opacity
1* Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2* Easily discernible translucent area, details of iris slightly obscured
3* Nacrous area, no details of iris visible, size of pupil barely discernible
4* Opaque cornea, iris not discernible through the opacity
IRIDIC IRRITATION:
0 Normal
1* Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive)
2* No reaction to Iight, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAL IRRITATION: redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 Blood vessels normal
1 Some blood vessels definitely hyperemic (injected)
2* Diffuse, crimson colour, individual vessels not easily discernible
3* Diffuse beefy red
CHEMOSIS: lids and/or nictating membranes
0 No swelling
1 Any swelling above normal (includes nictating membranes)
2* Obvious swelling with partial eversion of lids
3* Swelling with lids about half closed
4* Swelling with lids more than half closed
* Starred figures indicate positive effect
OBSERVATIONS
- Viability / mortality: daily
- Body weights: day 1 of test (application day) and at termination of test.
NECROPSY
- All rabbits were killed by intravenous injection of T61 into the ear vein.
- No macroscopic organ examination was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- CORROSION
- A slight diffuse or slight opacity was observed in all animals within 1 hour to 7 days. - Other effects:
- TOXICITY
- No acute toxic symptoms were observed in the animals during the test period.
MORTALITY
- No mortality occurred.
COLOURATION
- In the area of applicatlon a slight black to black staining of the cornea, lidhairs and conjunctivae by pigment or colouring of the test item was observed.
BODY WEIGHTS
- The body weight gains of all rabbits was similar.
NECROPSY
- No macroscopic organ examination was performed.
Any other information on results incl. tables
Extrapolation of the results of eye irritation studies in animals to man is valid only to a limited degree. The albino rabbit is more sensitive than man to ocular irritants or corrosives in most cases. Similar results in tests on other animal species may give more weight to extrapolation from animal studies to man.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (Serious Eye Damage) according to CLP Regulation (EC) No.1272/2008
- Conclusions:
- The test item was found to be damaging to the rabbit eye.
- Executive summary:
Eye irritation potential of the test item was evaluated in an in vivo experimental study performed according to the OECD Guideline 405 (1987) and EU method B.5 (1984). 0.1 g of undiluted, solid test item was administered to the left conjunctival sac of three female rabbits and was not rinsed. Irritation scores for corneal capacity (maximum: 4), iritis (maximum: 2), conjunctival redness (maximum: 3) and chemosis (maximum: 4) were recorded 1, 24, 48 and 72 hours and 7 and 14 days after application, and irritation scores for each parameter were calculated as mean of irritation scores at 24, 48 and 72 hours. Animals were also monitored for toxic symptoms, mortality, local discolouration and body weight change.
No mortality or symptoms of toxicity were observed during the study period. Body weights of all three animals did not differ significantly. Corneal opacity score was 1 for all animals. Iritis score was 0 for all animals. Conjunctival redness scores were 1, 1.67 and 0 for animals #1, #2 and #3, respectively. Chemosis scores were 0.67, 1.33 and 1 for animals #1, #2 and #3, respectively. All four irritation effects were reversible within the study period (14 days). In the area of application, a slight black staining of the cornea, lidhairs and conjunctivae by pigment or colouring from the test item was observed and persisted until the end of the study period (14 days), and reversibility was not possible to be demonstrated.
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