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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 12th to May 10th, 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:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 84/449, Annex V, Part B, Methods for Determination of Toxicity "Sub-Acute Toxicity (dermal"
- Version / remarks:
- amended July 1983, doc. XI/450/83 D
- GLP compliance:
- not specified
- Remarks:
- The conduct of this study was subjected to periodic inspections and the report audited by the Quality Assurance Unit.
- Limit test:
- 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:
- rat
- Strain:
- Wistar
- Remarks:
- KFM-Han., outbred, SPF-quality
- Details on species / strain selection:
- Recognized by the international guidelines as the recommended test system.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: males: 233 - 261 ; females: 211 - 236 g
- Housing: individually in Makrolon type-3 cages with wire mesh lids. The animals had standard granulated soft wood bedding ("Lignocel" Schill AG , Switzerland).
- Diet: standard Kliba 343, Batch 15/85 and 18/85 rat maintenance diet ("KLIBA"-Futter, Klingentalmuehle AG, Switzerland) ad libitum.
- Water: community tap water from Itingen was available ad libitum
- Acclimation period: One week
DETAILS OF FOOD AND WATER QUALITY:
The feed batch was analyzed for contaminants.
The water was analyzed for chemical and bacteriological contaminants.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial fluorescent light each day
IN-LIFE DATES: From: To: From April 12th to May 10th, 1985
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2% solution
- Details on exposure:
- TEST SITE
- Area of exposure: shaved skin of the back
- % coverage: about 10 % of the total body surface
- Type of wrap if used: occlusive bandage of elastic adhesive dressing
- Time intervals for shavings or clipplings: once weekly throughout the study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed of with luke-warm tap water
- Time after start of exposure: after termination of the daily treatment
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg body weight
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml/kg - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days per week
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for animal assignment: random
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
MORTALITY: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: twice daily prior to the following and after the application
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: twice weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: end of application period
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at 4 weeks of treatment
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: 10 per dose; males and females
- Parameters checked: erythrocyte count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and reticulocyte count, nucleated erythrocytes, total leukocyte count, differential leukocyte count, red cell morphology, thromboplastin and partial thromboplastin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 4 weeks of treatment
- Animals fasted: Yes
- How many animals: 10 per dose; males and females
- Parameters checked: glucose, urea, creatinine, bilirubin total, cholesterol total, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, calcium, phosphorus, sodium, potassium, chloride, albumin, protein total
URINALYSIS: Yes
- Time schedule for collection of urine: at 4 weeks of treatment
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked: pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, urine sediment,
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
All animals were necropsied and descriptions of all macroscopic abnormalities were recorded. Necropsies were performed by experienced prosectors supervised by a pathologist. All animals were killed by intraperitoneal injection of sodium pentobarbital.
HISTOPATHOLOGY: Yes
The tissue examined included: adrenal glands, brain, heart, ileum, kidneys, liver, lungs with mainstem bronchi, ovaries, spleen, testes, treated skin, untreated skin, gross lesions. - Statistics:
- The following statistical methods were used to analyze the bodycweights, food consumption, organ weights and clinical laboratory data:
Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the t-test based on a pooled variance estimate was applied for the comparison between the treated groups and the control groups.
The U-test was applied when the data could not be assumed to follow a normal distribution.
For the overall spontaneous mortality data, the Fisher's exact test for 2x2 tables was applied.
Group means were calculated for continous data and medians were calculated for discrete data (scores).
Individual values , means, standard deviations and statistcs were rounded off before printing. For example, test statistics were calculated on the basis of exact values for means and pooled
variances and then rounded off to two decimal places. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values.
References:
C.W. Ounnett: A Multiple Comparison Procedure for Comparing several Treatments with a Control, J. Amer. Statist. Assoc. 50, 1096-121 ( 1955)
R.G. Miller: Simultaneous Statistical Inference, Soringer Verlag, New-York (1981) .
R.A. Fisher: Statistical Methods for Research Workers, Oliver and Boyd, Edinburgh (1950).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight to moderate crusts on the treated skin were observed in 7 out of 10 animals of the test article-treated group between day 4 to 28. The observed signs were of different intensity and duration in the individual animals. No other local or systemic symotoms were observed in the animals of the test article-treated or control group.
- Mortality:
- no mortality observed
- Description (incidence):
- No death occurred during the study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No differences in body weight gain was observed between the animals of the test article-treated and control group during the test period.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No differences in food consumption were observed between the animals of the test article-treated and control group during the test period.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related findings were observed in any animal of the test article-treated or control group.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- All statistical differences in the results of the hematological parameters were considered to be incidental and of normal bioogical variation.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- All statistical differences in the results of the biochemical parameters were considered to be incidental and of normal bioogical variation.
- Endocrine findings:
- not examined
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- All statistical differences in the results of the urinalisis parameters were considered to be incidental and of normal bioogical variation.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- The observed increased absolute kidney weights in female animals of group 2 were related to the significantly increased final body weights. Therefore it could be stated that the organ weights and organ to body weight ratios were comparable between the rats of the control and test article treated group.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight focal inflammation was observed at the application site of two rats of group 2, only. In all other rats, the treated skin appeared to be normal.
- Neuropathological findings:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- dermal irritation
- food consumption and compound intake
- gross pathology
- haematology
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based upon the results obtained, the no-observable-effect level of test substance is greater than 1000 mg/kg bw/day for male and female rats.
- Executive summary:
The repeated dermal toxicity of the test item was evaluated following the guideline OECD Guideline 410. In this dermal toxicity study (limit-test), test item was applied to albino rats for 6 hours/day (7 days/week) for a total of 28 applications. The study was comprised of 2 groups, for a total of 20 rats.
The following dose of test item was applied: 0, 1000 mg/kg bw/day.
No death occurred during the study. The assessment of hematology, clinical biochemistry and urinalysis data indicated no changes of toxicological significance at termination of the treatment. Only local findings, described as slight to moderate crusts and slight focal inflammation of the skin were observed in the animals of the 1000 mg/kg group.
Based upon the results obtained, the no-observable-effect level of test substance is greater than 1000 mg/kg bw/day for male and female rats.
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