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EC number: 605-104-5 | CAS number: 157577-99-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- disodium 4-amino-3-[2-(4-{4-[2-(2,4-diaminophenyl)diazen-1-yl]benzenesulfonamido}phenyl)diazen-1-yl]-5-hydroxy-6-(2-phenyldiazen-1-yl)naphthalene-2,7-disulfonate
- EC Number:
- 605-104-5
- Cas Number:
- 157577-99-6
- Molecular formula:
- C34H26N10Na2O9S3
- IUPAC Name:
- disodium 4-amino-3-[2-(4-{4-[2-(2,4-diaminophenyl)diazen-1-yl]benzenesulfonamido}phenyl)diazen-1-yl]-5-hydroxy-6-(2-phenyldiazen-1-yl)naphthalene-2,7-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: laboratory albino rat (it is the preferred rodent species according to the guideline), females, nulliparous and non-pregnant
Strain: Wistar Han, monitored quality
Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760118
Sex: females
Age: 6-7 weeks at the time application
Acclimatisation: 6 days
Total number: 5 females
Housing: animal room with monitoring conditions, plastic breeding cages Velaz T4, sighting study 1 animal/cage, main study - 4 animals/cage
Diet: Altromin for rats, Manufacturer: Altromin Spezialfutter GmbH & Co. KG, Germany supplied via VELAZ
Water: drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
Microclimatic conditions: room temperature 22 + 3°C, permanently monitored
relative humidity 30 – 70 %, permanently monitored
light period 12-hour light/12 hour dark
Bedding: sterilized shavings of soft wood
Randomisation: according to the internal rule, at the start of the study the weight variation of animals was minimal
Identification of animals: colour marks on tail of animals, each cage was marked with the number of study, sex and dose of the test item
Health condition: certificate of good health condition – from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study
About twenty hours before oral administration the animals were not fed, water was given ad libitum. Immediately before application the animals were weighed. The feed was given to animals 3 hours after application of the test item.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Immediately before application the test item was weighed and mixed in vehicle (Aqua pro iniectione) and resulting suspension was administered to the stomach by tube. The single volume of administered suspension was 1 ml/100 g of animal body weight
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- Sighting study - the dose level of 2000 mg/kg was used as the starting dose - no death of animal was recorded.
Main study - on the basis of result of sighting study dose level 2000 mg/kg with four animals was used. No death of animals was detected.
Final number of animals for dose level 2000 mg/kg – 5 animals (1 animal – sighting study and 4 animals - main study).
Animals were weighed before application, at the 8th day of study and at the 15th day, before euthanasia of animals. Average body weight in a group was calculated from individual body weights. Body weight increments were calculated from body weight at the start of the study, the first week and at the end of the study.
After application the animals were observed individually:
- the first day: twice (30 minutes and 3 hours after application)
- the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotoric activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
The results of the observations were recorded on special data sheets.
All test animals survived to the end of study were sacrificed on the 15th day and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death recorded
- Clinical signs:
- other: No clinical sings of intoxication were observed during the study
- Gross pathology:
- No pathologic macroscopic changes were diagnosed during pathological examination.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified for acute oral toxicity
- Conclusions:
- The test item toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test item administered at the dose of 2000 mg/kg caused no death of animals. No clinical sings of intoxication were observed.
Body weight and weight increments were adequate to species, sex and age of animals in experiment. No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test item, Acid Black 234, for female rats is higher than 2000 mg/kg of body weight - Executive summary:
The aim of the study was to investigate acute toxic effects of the test item Acid Black 234, after a single oral administration to Wistar rats.
The testing was performed according to the OECD Test Guideline No. 420: Acute Oral Toxicity – Fixed Dose Procedure, adopted 17th December 2001.
With respect to information available indicating that the test item is likely to be nontoxic, the study was performed as limit test.
First the sighting study was performed, using the starting dose of 2000 mg/kg of body weight with one female, then followed main study with group of four females, dosed by the same dose of 2000 mg/kg of body weight.
The test item was administered in a single dose by gavage using a stomach tube to female Wistar CRL rats. After dosing the animals were observed individually for a total of 14 day. At the end of the test surviving animals were killed. Necropsy of all animals were carried out, and all gross pathological changes were recorded.
The test item administered at the dose level of 2000 mg/kg did not cause the death of animals. No clinical signs of intoxication were recorded. No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test item, Acid Black 234, for female rats is higher than 2000 mg/kg of body weight.
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