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EC number: 943-382-2 | CAS number: -
- 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
LD50 oral acute rat > 2000 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:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Study period:
- April 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines. Further details in the endpoint summary.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: First attachments of 30 July 1996 DIRECTIVE 96/54/EC (L 248)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized vendor
- Weight at study initiation: 175 ± 5 g
- Housing: Makrolon cage (48 x 27 x 20 cm), with bedding of wood chips.
- Diet: free access to an experimental diet for rats, provided by an accredited supplier.
- Water: tap water bottles ad libitum
- Acclimation period: 7 days
- Health check: during acclimatation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (± 2°C).
- Humidity (%): 55% (± 25%)
- Air changes (per hr): 15 air change per hour with filtered air (5 µm)
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg for 20 ml of water
- Amount of vehicle : 2 ml of solution for 100 mg of body weight - Doses:
- 2000, 200, and 25 mg/Kg bw
- No. of animals per sex per dose:
- 3 animals per each sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Skin, hair, eyes, mucous membranes, respiratory, circulatory system, central and autonomic nervous system, somatomotor activity and behavior patterns. Particular attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma. - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 1 500 mL/kg bw
- Based on:
- act. ingr.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 500 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no patology observed after necropsy
- Interpretation of results:
- other: not toxic for oral administration.
- Conclusions:
- The substance was tested with a limit test method and acute oral toxicity for rats is LD50 > 1500 mg/kg bw based on active ingredient, LD50 > 2000 mg/kg test item.
- Executive summary:
The substance was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw. The substance is not toxic for oral administration.
Reference
sacrifice:
All survived animals are killed by CO2 administration
The test was conducted as a limit test, since no mortality was recorded, no further test or analysis are necessary
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral exposure pattern is covered by one study on the similar substance 1.
The oral toxicity has been performed just as a limit test at 2000 mg/Kg bw on the test item, with no effects, it can be concluded that the substance does not arise any concern for acute toxicity by oral route.
Based on Read Across with similar substance 1 and based on the QSAR prediction, also Acid Brown 349 can be considered as non toxic for acute oral toxicity.
Read across is discussed more in detail in the read across document in section 13
Justification for selection of acute toxicity – oral endpoint
The study is well described
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be mroe than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.
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