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EC number: 400-920-6 | CAS number: 89857-06-7
- 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:
- From February 12th to February 15th, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1985
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- EWG Directive 84/449/ EWG, Amtsblatt der Europaeischen Gemein-schaften L 251, Jahrgang 27, 19. 9. 84. B.4 Akute Toxizitaet-Hautreizung / 106
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 400-920-6
- EC Name:
- -
- Cas Number:
- 89857-06-7
- Molecular formula:
- C50 H53 N11 O14 S
- IUPAC Name:
- 5'-[2-(7-{2-[4-(2-{1'-[3-(dimethylazaniumyl)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-8-hydroxy-6-sulfonatonaphthalen-2-yl)diazen-1-yl]-6'-hydroxy-3,4'-dimethyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium bis(2-hydroxypropanoate)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf /Switzerland
- Age at study initiation: 15 -16 weeks
- Weight at study initiation: 2.8 - 3.2 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: pelleted standard KIiba 341, Batch 3/84 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, Switzerland), ad libitum
- Water: community tap water from Itingen, ad libitum
- Acclimation period: four days under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 10 -15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, at least 8 hours music/light period
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after removing the gauze patches
- Number of animals:
- 3 rabbits (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm²
- Type of wrap if used: guaze patch covered with aluminium foil and then covered with an occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after the application, the dressing was removed and the skin was flushed with luke warm tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Viability/Mortality/Toxicity: daily
- Body Weight: pre-test, day 1 and at termination of test on a Mettler PK 16 balance
- Symptoms: The skin reactions were assessed 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.
- Possible corrosive properties of the test article and the color to the treated skin area were recorded.
SCORING SYSTEM: according to OECD 404
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 slight eschar formation (injuries in depth): 4
Maximum possible: 4
Oedema 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
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Test item showed a primary irritation score of 0 when applied to intact rabbit skin.
No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
Any other information on results incl. tables
COLORATION
In the area of application a severe black discoloration of the skin was observed which could be related to effects of the test article .
BODY WEIGHTS
The body weight gain of all rabbits was similar.
TOXIC SYMPTOMS/MORTALITY
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
NECROPSY
Due to the results obtainedr no macroscopic organ examination was indicated.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
The skin irritation potential of the substance, when single doses of the test item are placed on the skin of rabbits, was evaluated in an in vivo experimental study according to the OECD Guideline 404. On test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area and the skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removing of the dressing, gauze patch and test article.
Under the conditions of this experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application a severe black discoloration of the skin was observed which could be related to effects of the test article. No corrosion effect had occurred on the skin at each measuring interval.The mean value of the scores for each type of lesion, calculated for each animal separately is the following:
Animal No. Sex Mean 24 -72 hours
Erythema Edema
125 male 0 0
126 male 0 0
127 female 0 0In conclusion, it is reasonable to not classify the substance as skin irritant according to the CLP Regulation (EC 1272/2008).
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