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EC number: 260-124-8 | CAS number: 56358-09-9
- 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
- Type of information:
- other: Assessment from available information
- Adequacy of study:
- key study
- Study period:
- February - April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Evaluation of toxicokinetics of the substance Solvent Red 19E was performed according to the demand given in part 8.8.1 of Annex VIII to the Regulation (EC) No. 1907/2006 (REACH) : “Assessment of the toxicokinetic behaviour of the substance to the extent that could be derived from the relevant available information”.
The evaluation of toxicokinetics is normally based on information from three sources:
- Experimental data of toxicological tests
- Literature data obtained from internet
- Data from toxicological databases – free and commercial - GLP compliance:
- no
- Details on absorption:
- The substance did not enter the body via the eye. The substance could enter the body via the skin, at least to deeper layers of dermis and hypodermis. No systemic toxicity after dermal exposure was recorded.
- Details on distribution in tissues:
- Following repeated oral exposure, the test material was absorbed from the digestive tract and distributed through the body. Evidence of the test material in soem organs and body fat was evident. The main target orgal was probably the liver.
- Details on excretion:
- No data on excretion on the test material were found.
- Metabolites identified:
- not measured
- Details on metabolites:
- No metabolism data on the substance were found.
- Conclusions:
- The material can be absorbed via the oral, dermal and inhalation routes, and is widely distributed around the body. There is no data on the metabolism or excretion of the material. In the absence of quantitative data, for the purposes of risk assessment, absorption values of 100 % (inhalation), 100 % (oral) and 100 % (dermal) are adopted.
- Executive summary:
The substance evaluated, Solvent Red 19E, has low acute oral toxicity. Only mild clinical symptoms of intoxication were found (piloerection, gibbous posture) and there was no evidence of systemic toxicity.
The substance did not enter the body via the eye. No irritating effect and no clinical signs of intoxication were detected.
It seems that the substance could enter the body via skin at least to deeper layers of dermis and hypodermis. This conclusion is based on the following observations:
After acute application to the skin, mild clinical signs of intoxication – diarrhoea, and skin around anus coloured were recorded. Moreover diffuse mixed infiltration (mononuclear cells and granulocytes) in dermis was recorded after histopathological skin examination.
In skin sensitisation test the substance elicited increased cell proliferation in the lymph node draining the site of application and this result showed that the test substance has ability to enter the body of mice.
No systemic toxicity after dermal exposure was recorded.
Repeated oral exposition to the substance resulted in entering of substance into organism and its systemic distribution. After oral administration, the substance caused systemic intoxication of organism. It is absorbed from digestive tract and distributed through the body of rats. This distribution was confirmed during macroscopic examination of rats – red colouring of some organs and body fat was evident. The main target organ in organism is probably liver.
With respect to the results of reproduction toxicity part of repeated study it is possible to confirm an adverse effect of the test substance treatment – the total number of pups was decreased. Test substance probably penetrates through the placental barrier – decreased number of pups in treated animals was reported. Development of pups was unchanged.
No data about metabolism and excretion of the evaluated substance were found.
In the absence of quantitative data, default absorption values of 100 % (inhalation), 50 % (oral) and 50 % (dermal) are adopted for the purposes of risk assessment in accordance with ECHA guidance.
Reference
Description of key information
No systemic toxicity after dermal exposure
was recorded.
After oral administration, the substance caused systemic intoxication of
the organism. It is absorbed from the digestive tract and distributed
through the body of rats. This distribution was confirmed during
macroscopic examination of rats.
No data about metabolism and excretion of the evaluated substance were
found.
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
Experimental toxicokinetics studies are not available. Assessment of the toxicokinetic behavior of the substance was performed following the relevant available information.
The evaluation of toxicokinetics is based on information from following sources:
- Experimental data of toxicological tests
- Literature data
- Data from toxicological databases – free and commercial
Physicochemical properties of the substance:
Molecular weight: 492
Water solubility: highly insoluble
Partition coefficient: log Kow >10
The substance evaluated, Solvent Red 19E, has low acute oral toxicity. Only mild clinical symptoms of intoxication were found (piloerection, gibbous posture) and there was no evidence of systemic toxicity.
The substance did not enter the body via the eye. No irritating effect and no clinical signs of intoxication were detected.
It seems that the substance could enter the body via skin at least to deeper layers of dermis and hypodermis . This conclusion is based on the following observations:
After acute application to the skin, mild clinical signs of intoxication – diarrhoea, and skin around anus coloured were recorded. Moreover diffuse mixed infiltration (mononuclear cells and granulocytes) in dermis was recorded after histopathological skin examination.
In skin sensitisation test the substance elicited increased cell proliferation in the lymph node draining the site of application and this result showed that the test substance has ability to enter the body of mice.
No systemic toxicity after dermal exposure was recorded.
Repeated oral exposition to the substance resulted in entering of substance into organism and its systemic distribution. After oral administration, the substance caused systemic intoxication of organism. It is absorbed from digestive tract and distributed through the body of rats. This distribution was confirmed during macroscopic examination of rats – red colouring of some organs and body fat was evident. The main target organ in organism is probably liver.
With respect to the results of reproduction toxicity part of repeated study it is possible to confirm an adverse effect of the test substance treatment – the total number of pups was decreased. Test substance probably penetrates through the placental barrier – decreased number of pups in treated animals was reported. Development of pups was unchanged.
No data about metabolism and excretion of the evaluated substance were found.
In the absence of quantitative data, default absorption values of 100 % (inhalation), 100 % (oral) and 100 % (dermal) are adopted for the purposes of risk assessment in accordance with ECHA guidance.
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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