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EC number: 277-761-2 | CAS number: 74196-18-2
- 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:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acid Black 076
- IUPAC Name:
- Acid Black 076
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: KFM, 4414 Fullinsdorf, CH
- Age at study initiation: young adult
- Weight at study initiation: 160 to 205 g
- Fasting period before study: access of food only was prevented from approximately 18 hours prior and four hours after the dosingl water bottles were withdrawn two hours prior and four hours after dosing
- Housing: individually in Macrolon cages
- Diet: standard laboratory pelleted diet (KLIBA no. 24-343-4 from Klingentalmuhle AG., Basle); ad libitum.
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: 15 air changes/hour.
- Photoperiod: 12 hours cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 20 ml/kg bw
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- - Preliminary study: two animals per sex per dose
- Main study: five animals per sex per dose - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were monitored for clinical signs and mortality soon after dosing, then at hourly intervals for the remainder of day 1; on the subsequent days the animals were observed once in the morning and once in the late afternoon
- Frequency of weighing: individual body weights on days 1, 7 and 14
- Necropsy of survivors performed: yes, surviving animals were killed after two weeks
- Other examinations performed: all animals which died during the study and those killed after two weeks were subjected to a macroscopic postmortem examination; the macroscopic appearance of the abnormal organs was recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Preliminary test: no mortality observed
Main test: one male rat and three female rats - Clinical signs:
- The animals were flaccid, weak and showed decreased movement, exophthalamus, rough coat, gasping labored and decreased respiration, and diarrhea.
- Body weight:
- See Table 2: Results of the main study, in "Any other information on results", below.
- Gross pathology:
- No special findings
Any other information on results incl. tables
Table 1: Results of the preliminary study.
Dose (mg/kg) | Mortality ratio (no. deaths/no. dosed) | Time of death after dosing | ||
males | females | combined | ||
10000 | 0/2 | 0/2 | 0/4 | - |
Table 2: Results of the main study.
Sex | Dose (mg/kg) | Body weight (g) at | Mortality ratio (no. deaths/no. dosed) | Time of death after dosing (hours) | ||
dosing | 1 week | 2 weeks | ||||
M | 10000 | 163.0 | 183.4 | 235.0 | 1/5 | 26 |
F | 10000 | 198.0 | 207.5 | 220.0 | 3/5 | 5, 5, 14 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) no. 1272/2008
- Conclusions:
- The LD50 for oral administration of the test item was found to exceed 10000 mg/kg body weight.
- Executive summary:
The acute oral toxicity of the test item was evaluated in an experimental study equivalent to the OECD Guideline 401 (1987). A preliminary study was carried out to establish a dosing regimen: two male and two female Wistar rats were administered 10,000 mg test item/kg bw and monitored for mortality. In the main study, five male and five female Wistar rats were administered 10,000 mg test item/kg bw by oral gavage. Clinical symptoms and mortality were monitored after administration for an observation period of 14 days, thereafter all animals were submitted to necropsy and macroscopic examination.
No mortality was observed among animals in the preliminary study. In the main study, 1 male and 3 females died before the end of the observation period. The male mortality occurred 26 hours after dosing; the female mortalities occurred 5, 5 and 14 hours after dosing. Mean body weights of surviving males and females increased throughout the observation period. The LD50 of the test item was found to exceed 10000 mg test item/kg body weight.
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