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EC number: 250-792-9 | CAS number: 31765-95-4
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Saturnová šeď LCG: 95.2 % (w/w)black powder
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: TOP VELAZ, Praha, Czech Republic- Weight at study initiation: cca 150 g- Housing: 5 animals per cage, separately by sex, controlled conditions- Diet (e.g. ad libitum): standard commercially produced granular feed 10 g/animal/day- Water (e.g. ad libitum): tap water ad libitum- Fasting period before study: 20 hours- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE - Concentration in vehicle: 20 % (w/w) water suspension - Amount of vehicle: calculated based on individual body weight
- Doses:
- 6.310, 7.943, 10.00 and 12.59 g/kg
- No. of animals per sex per dose:
- 5 animals pr sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations: immediately after application, after 30 min, after 3 hours, following day morning and afternoon, next days at least once a day - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ appearance and weights, urine (if present) orientation biochemical tests
- Statistics:
- Inner statistical program PROBIT (1991).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 9 370 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 8 730 - < 10 062
- Mortality:
- 6.310 g/kg: 0/5 males 0/5 females7.943 g/kg: 3/5 males 0/5 females10.00 g/kg: 2/5 males 3/5 females12.59 g/kg: 5/5 males 5/5 females
- Clinical signs:
- 6.310 g/kgWithout any clinical symptoms of intoxication.7.943 g/kgDiarrhea, disappeared within 4 days. 3 males died.10.00 g/kgDiarrhea, cyanosis. Three animals (2 males/1 female) had symptoms of somnolence. Clinical symptoms disappeared within 3 days. 2 males and 3 females died.12.59 g/kgPiloerection, anemic mucosa, somnolence, bloody nasal discharge in females. One male died the third day after application, all other animals died within two days after application.
- Body weight:
- Average weight of the test animalsMales6.310 g/kg: 154.9 g (start) 173.5 g (end) +18.6 g increment10.00 g/kg: 164.3 g (start) 172.4 g (end) +8.1 g incrementFemales6.310 g/kg: 154.3 g (start) 168.6 g (end) +14.3 g increment7.943 g/kg: 159.9 g (start) 171.5 g (end) +11.6 g increment(Only doses are listed where survived at least 3 animals.)
- Gross pathology:
- Died animals: stomach and intestine catarrh.Survived animals: without any pathological symptoms.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance, Direct Black 112, is not classified as acute toxic by oral exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Saturnová šeď LCG: 95.2 % (w/w)black powder
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: TOP VELAZ, Praha, Czech Republic- Weight at study initiation: cca 200 g- Housing: individuai in cage, controlled conditions- Diet (e.g. ad libitum): standard commercially produced granular feed 10 g/animal/day- Water (e.g. ad libitum): tap water ad libitum- Fasting period before study: 20 hours- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE - Area of exposure: 6 × 6 cm - Type of wrap if used: occlusive REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24 h TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5.020 g/kg - For solids, paste formed: yes
- Duration of exposure:
- 24 hours
- Doses:
- 5.020 g/kg
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations: immediately after application, after 30 min, after 3 hours, following day morning and afternoon, next days at least once a day - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ appearance and weights, urine (if present) orientation biochemical tests
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died.
- Clinical signs:
- No signs of intoxication were observed.
- Body weight:
- Average weight of the test animalsMales5.020 g/kg: 207.0 g (start) 263.5 g (end) +56.5 g incrementFemales5.020 g/kg: 200.3 g (start) 234.3 g (end) +34.0 g increment
- Gross pathology:
- Without any pathological symptoms.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance, Direct Black 112, is not classified as acute toxic by dermal exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Based on the test results and according to the CLP criteria for classification and labelling requirements for dangerous substances and preparations, the test substance, Direct Black 112, did not fall into any of quoted categories of toxicity both oral and dermal, and has no obligatory labelling requirement in this respect.
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