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Diss Factsheets
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EC number: 820-015-3 | CAS number: 129874-15-3
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Assessment made using data derived from guideline studies
- Objective of study:
- other: Assessment of toxicokinetic behaviour
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The toxicokinetic assessment is prepared by evaluating the available physical properties and toxicological properties.
- GLP compliance:
- no
- Remarks:
- Assessment
- Radiolabelling:
- no
- Preliminary studies:
- Genetic toxicological information:
Bacterial reverse mutation test: Negative; 5 mg/plate was the highest concentration (according to the SuperLab Final Report M62-151100084).
In vitro mammalian chromosomal aberration test: Negative; 2.0 mg/mL was the highest concentration treated with or without S9 Mix (according to the SuperLab Final Report (M62-151100085).
In vitro mammalian cell gene mutation test: Negative; 2.0 mg/mL was the highest concentration treated with or without S9 Mix (according to the SuperLab Final Report M62-151100091).
General toxicological information:
Subacute oral toxicity: NOAEL > 1,000 mg/kg B.W. (according to the SuperLab Final Report M62-151100083).
Acute dermal toxicity: LD50 > 2,000 mg/kg B.W. (according to the SuperLab Final Report M62-151100081).
Skin sensitization: Negative (test concentration: 6%) (according to the SuperLab Final Report M62-151100082).
Ecological toxicological information:
Adsorption coefficient test: sludge Koc < 28.84; soil Koc = 61.24 (according to the SuperLab Final Report M62-151100089).
Activated sludge respiration inhibition test: EC50 > 1,000 mg/L (according to the SuperLab Final Report M62-151100088).
Alga growth inhibition test: ErC50 = 2.81 mg/L; EyC50 = 0.76 mg/L (according to the SuperLab Final Report M62-151100086)
Daphnia sp., Acute immobilisation test: EC50 = 3.34 mg/L (according to the SuperLab Final Report M62-151100087).
Ready biodegradability: It was not the readily biodegradable article (according to the SuperLab Final Report M62-151100090). - Type:
- absorption
- Results:
- No evidence of oral or dermal absorption. Discoloured faeces observed after dosing of the coloured material.
- Type:
- distribution
- Results:
- In the absence of apparent absorption, distribution was not seen
- Type:
- metabolism
- Results:
- There is no evidence of metabolic activity
- Type:
- excretion
- Results:
- In the absence of apparent absorption, no excretion was seen. Discoloured faeces observed after dosing of the coloured material.
- Details on absorption:
- with the repeat oral study and reproduction toxicity screening tests conclude that there was no adverse effect at the top dose of 1000 mg/kg/day.
However, had absorption taken place, the intense colour of the test material could be expected to have provided visual observations to confirm absorption. There was no red discolouration of organs and this suggests that there is no significant absorption.
Red/purple faeces were observed through the test period for the repeated dose toxicity studies suggesting that a significant proportion of the substance passes through without absorption. The intestines were not observed to be red, but otherwise non-affected by the test material in the oral reproduction toxicity study.
There is no evidence of dermal absorption and from the high molecular weight and lack of surface active properties, it is likely to have a low rate of dermal absorption. Guidance suggests that a default of 10% can be used in such cases.
Discolouration of skin and fur was seen in many animals in the reproductive toxicity screening test, but this was considered to grooming activities where faeces and saliva are discoloured. - Details on distribution in tissues:
- Discolouration of organs was not noted and no other adverse effects reported. In the absence of toxicological findings, no target organ has been identified.
The substance is water soluble and distribution would be expected had there been absorption. - Details on excretion:
- The kidneys and urine were not discoloured, suggesting no excretion of absorbed material in the urine. However, the intense dark red of the faeces suggests that a significant proportion is excreted unchanged following oral exposure.
In the oral reproduction toxicity screening test, red faeces were seen shortly after administration representing normal passage through the GI tract. - Conclusions:
- Interpretation of results: low bioaccumulation potential based on study results
- Executive summary:
The intense colour of the test material means it is potentially possible to identify absorption, distribution and excretion. In the absence of specific toxicokinetic data from animal testing it is not possible to make firm conclusions concerning metabolism, but the limited biodegradation will indicate that some limited metabolism is likely.
There is no indication of accumulation.
It is not considered appropriate to perform further animal studies on this substance.
Reference
Estimated dermal adsorption factor 10%
Low bioaccumulation potential
Description of key information
Low bioaccumulation potential.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - dermal (%):
- 10
Additional information
The substance has been extensively tested for REACH Registration and animal test work failed to indicate any adverse effect leading to classification up to accepted limits of test exposure. Likewise, the in-vitro mutagenicity testing failed to lead to any relevant findings.
The intense colour of the test material means it is possible to identify absorption, distribution and excretion through direct observation of animals during dosing and from necropsy findings.
In the absence of specific toxicokinetic data from animal testing it is not possible to make firm conclusions concerning metabolism, but the limited biodegradation will indicate that some slow metabolism is likely. There is no indication of accumulation.
It is not considered appropriate to perform further animal studies on this substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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