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EC number: 276-982-1 | CAS number: 72905-97-6
- 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
Endpoint summary
Administrative data
Description of key information
acute oral toxicity LD 50 = 9370 mg/kg bw
acute dermal toxicity LD 50 = 5000 mg/kg bw
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Doses:
- 6310 mg/kg bw; 7943 mg/kg bw; 10000 mg/kg bw; 12590 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per each concentration
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 for males and females was calculated, 9370 mg/kg bw.
- Executive summary:
Direct black 112 was tested for the acute oral toxicity. 5 Males and 5 females of Wistar rats were tested per concentrations, 6310 mg/kg bw, 7943 mg/kg bw, 10000 mg/kg bw and 12590 mg/kg bw. LD 50 for males and females was calculated, 9370 mg/kg bw.
Catarrh of stomach was recorded in all dead animals.
No pathological findings were recorded in sacrificed animals at the end of test.
Clinical signs of intoxication in lethal dose level are anemia, cyanosis followed by somnolence.
The test sample affected digestive tract – diarrhea, catarrh of stomach and intestine were recorded. These findings are reversible till 14 days.
Reference
Mortality
|
Number of dead animals |
|
|
Does (mg/kg) |
males |
females |
% |
6310 |
0 |
0 |
0 |
7943 |
3 |
0 |
30 |
10000 |
2 |
3 |
50 |
12590 |
5 |
5 |
100 |
Higher percentage of mortality was recorded in males.
Dose level 6310 mg/kg bw
Males: no clinical signs of intoxication were observed, all animals survived.
Females: no clinical signs of intoxication were observed, all animals survived.
Dose level 7943 mg/kg bw
Males: 3 animals died till the 2ndday; diarrhea of all animals was recorded 3 hours after application. Survived animals were without clinical signs of intoxication till four days after application.
Females: Diarrhoea was observed in all animals; all animals were without clinical signs of intoxication till four days and survived.
Dose level 10000 mg/kg bw
Males: Disarrhoea in all animals, somnolence in two animals were recorded. All animals were cyanotic. Two animals died till the 2ndday after application. Survived animals were without clinical signs of intoxication till three days after application.
Females: The same clinical signs as in males were observed in females, somnolence was observed in one female, 3 females died till the 2ndday after application. Survived animals were without clinical signs of intoxication till tree days after application.
Dose at 12590 mg/kg bw
Males: The first animal died 3 hrs after application; next three died in the 2ndday after application and one male died the 3rdday.
The clinical signs of intoxication were observed 3 hrs after application: piloerction, anemic mucous membranes and somnolence.
Females: All animals died till the 2ndday after application, the same clinical signs as in males were observed and also red discharge from nostrils was recorded.
Overall
Catarrh of stomach was recorded in all dead animals.
No pathological findings were recorded in sacrificed animals at the end of test.
Clinical signs of intoxication in lethal dose level are anemia, cyanosis followed by somnolence.
The test sample affected digestive tract – diarrhea, catarrh of stomach and intestine were recorded. These findings are reversible till 14 days.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 9 370 mg/kg bw
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- The shaved back of animals was wiped by gauze soaked in acetone – ethanol (1:1), then by gauze soaked in saline. Relevant amount of the test sample was applied on the depilated area of skin, covered by mull, plastic foil and held in contact by technical tape. Then fixative bandage was put on. The bandage was overlapped by technical tape and fixed around the whole body so that the test sample is in contact with the skin and cannot be ingested. After 24 hours the bandage was removed.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females were tested.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
- Executive summary:
Direct black 112 was tested for the acute dermal toxicity. 5 males and 5 females of Wistar rats were tested at 5000 mg/kg bw. After 24 hr exposure, the toxicity was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.
The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
Reference
Toxicity of the test sample was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.
The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Direct black 112 was tested for the acute oral toxicity. 5 Males and 5 females of Wistar rats were tested per concentrations, 6310 mg/kg bw, 7943 mg/kg bw, 10000 mg/kg bw and 12590 mg/kg bw. Catarrh of stomach was recorded in all dead animals. No pathological findings were recorded in sacrificed animals at the end of test. Clinical signs of intoxication in lethal dose level are anemia, cyanosis followed by somnolence. The test sample affected digestive tract – diarrhea, catarrh of stomach and intestine were recorded. These findings are reversible till 14 days.
LD 50 for males and females was calculated, 9370 mg/kg bw.
Direct black 112 was tested for the acute dermal toxicity. 5 males and 5 females of Wistar rats were tested at 5000 mg/kg bw. After 24 hr exposure, the toxicity was established according to evaluation of mortality, clinical signs of intoxication, body weight increment, and pathological findings within 14-day test. No clinical signs of intoxication were observed after application of the test sample. No pathological-anatomical findings were recorded within necropsy.
The LD50 value is greater than 5000 mg/kg of body weight. The test sample, Direct black 112, is not absorbed through the skin.
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute dermal and oral toxicity according to CLP regulation 1272/2008.
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