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EC number: 404-600-7 | CAS number: 129009-88-7 EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
- 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: Evaluation and assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Evaluation and assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data
- Reason / purpose for cross-reference:
- reference to other study
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Evaluation and assessment of the toxicokinetic properties based on the results obtained for the toxicological end-points with simultaneous reference to physico-chemical data such as solubility in solvents, log Pow and hydrolytic stability is included
- GLP compliance:
- no
- Remarks:
- The studies this assessment is based on were conducted according to GLP
- Radiolabelling:
- no
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
- Type:
- absorption
- Results:
- Insignificant or no dermal absorptive potential. Seems not to be absorbed from the gastrointestinal tract and therefore a significant bioaccumulation potential can be excluded
- Type:
- other: accumulation
- Results:
- Accumulation of the test substance in the body is unlikely.
- Conclusions:
- Based on the results obtained in various toxicological examinations, it can be concluded that the test substance does not exhibit conspicuous toxicokinetic behaviour.
- Executive summary:
Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. An approximate indication of the toxicokinetic pattern can be gained from the results of basic toxicity testing. The assessment of the toxicokinetic properties of Reaktiv-Orange FD 19969 FW given below is based on the results obtained for the following toxicological endpoints:
- Acute oral toxicity
- Acute dermal toxicity
- Skin irritation
- Skin sensitisation
- Ames-Test
- In vitro cytogenetic assay
- Micronucleus-Test
- Subacute (28-day) oral toxicity
All studies were carried out according to the principles of Good Laboratory Practice and met the requirements of the OECD an EU-Guideline for the Testing of Chemicals.
Simultaneously reference to physico-chemical data such as solubility in solvents, log Pow and hydrolytic stability is included.
Toxicological Profile:
Reaktiv-Orange FD 19969 FW was tested for acute oral toxicity in male and female Wistar rats. After application of 2000 mg/kg body weight by gavage, only short-lasting unspecific clinical symptoms but no lethality occurred. Based on the results of this study the median lethal dose (LD50) of Reaktiv-Orange ED 19969 FW in the rat is greater than 2 000 mg/kg body weight. Dermal treatment with 2000 mg/kg body weight also caused no mortality nor symptoms of toxicological relevance. Reaktiv-Orange FD 19969 FW is not irritating to skin and is not a skin sensitiser in the maximisation test. According to the results of the acute dermal toxicity study as well as the skin irritation and sensitisation data it can be concluded that Reaktiv-Orange ED 19969 FW has no significant dermal absorptive potential.
Reaktiv-Orange FD 19969 FW was not mutagenic in a standard Ames-Test in Salmonella typhimurium TA100, TA1535, TA1537 and TA98 either with or without an exogenous metabolising system (S9-mix from Arocior 1254 pre-treated rats) and was also not mutagenic in the preincubation method according to Prival, Reaktiv-Orange FD 19969 FW induced chromosome mutations (aberrations) in V79 Chinese hamster cells both in the presence as well as in the absence of a metabolic activation system. However, a micronucleus-test has not shown any indications of chromosome mutations under condition in vivo.
Based on the results of a subacute (28-day) oral toxicity study, daily administration of doses up to 1 000 mg/kg body weight to rats has not caused compound-related lethality. Beside orange faeces indicating the excretion of Reaktiv-Orange FD 19969 FW in unchanged form, no side effects occurred. Body weight development, haematological and clinical chemistry parameters as well as organ weights were unaffected. Macroscopical and histo-pathological examinations have not revealed a compound-related effect. Thus the 'No observed Adverse Effect Level' (NOAEL) was 1000 mg/kg body weight per day.
Evaluation and Assessment:
Based on all available data, Reaktiv-Orange FD 19969 FW does not exhibit a conspicuous toxicokinetic behaviour. Reaktiv-Orange FD 19969 FW has a very low acute and systemic toxic potential. The results from all studies with dermal exposure indicates that Reaktiv-Orange FD 19969 FW has insignificant or no dermal absorptive potential. Additionally, taking the results of the subacute oral toxicity study into account, Reaktiv-Orange FD 19969 FW seems not to be absorbed from the gastrointestinal tract and therefore a significant bioaccumulation potential can be excluded. From the mutagenicity assays it appears that Reaktiv-Orange has some clastogenic potential. However, a positive response was only seen in vitro whereas under conditions in vivo no chromosome mutation occurred. Since Reaktiv-Orange FD 19969 FW is not expected to be absorbed from the gastrointestinal tract, this suspected clastogenic potential most likely does not represent a significant risk under conditions in vivo. This view is also supported by the negative micronucleus-test.
Summary:
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reaktiv-Orange FD 19969 FW. The data indicate that there is little or no dermal absorptive potential. Likewise, the data from the subacute oral toxicity study are not indicative of a significant uptake of Reaktiv-Orange FD 19969 FW from the gastrointestinal tract. Thus, a major systemic burden is not to be expected pointing also to low or lacking bioaccumulation properties. Although from limited in vitro studies a clastogenic potential of Reaktiv-Orange FD 19969 FW must be assumed, a significant risk under conditions in vivo can be excluded because of the very low or lacking systemic uptake of Reaktiv-Orange FD 19969 FW as demonstrated in the subacute oral toxicity study and further supported by the negative micronucleus-test.
Reference
Evaluation and Assessment:
Based on all available data, test substance does not exhibit conspicuous toxicokinetic behaviour. Test substance has a very low acute and systemic toxic potential. The result from all studies with dermal exposure indicates that test substance has insignificant or no dermal absorptive potential. Additionally, taking the results of the subacute oral toxicity study into account, test substance seems not to be absorbed from the gastrointestinal tract. Thus, a major systemic burden is not to be expected pointing also to low or lacking bioaccumulation properties
Description of key information
Based on the physico-chemical properties of test substance and the results obtained in various toxicological examinations, it can be concluded that thetest substance does not exhibit conspicuous toxicokinetic behaviour.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
- Acute oral toxicity
- Acute dermal toxicity
- Skin irritation
- Skin sensitisation
- Ames-Test
- In vitro cytogenetic assay
- Micronucleus-Test
- Subacute (28-day) oral toxicity
Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. An approximate indication of the toxicokinetic pattern can be gained from the results of basic toxicity testing. The assessment of the toxicokinetic properties of Reaktiv-Orange FD 19969 FW given below is based on the results obtained for the following toxicological endpoints:
All studies were carried out according to the principles of Good Laboratory Practice and met the requirements of the OECD an EU-Guideline for the Testing of Chemicals.
Simultaneously reference to physico-chemical data such as solubility in solvents, log Pow and hydrolytic stability is included.
Toxicological Profile:
Reaktiv-Orange FD 19969 FW was tested for acute oral toxicity in male and female Wistar rats. After application of 2000 mg/kg body weight by gavage, only short-lasting unspecific clinical symptoms but no lethality occurred. Based on the results of this study the median lethal dose (LD50) of Reaktiv-Orange ED 19969 FW in the rat is greater than 2 000 mg/kg body weight. Dermal treatment with 2000 mg/kg body weight also caused no mortality nor symptoms of toxicological relevance. Reaktiv-Orange FD 19969 FW is not irritating to skin and is not a skin sensitiser in the maximisation test. According to the results of the acute dermal toxicity study as well as the skin irritation and sensitisation data it can be concluded that Reaktiv-Orange ED 19969 FW has no significant dermal absorptive potential.
Reaktiv-Orange FD 19969 FW was not mutagenic in a standard Ames-Test in Salmonella typhimurium TA100, TA1535, TA1537 and TA98 either with or without an exogenous metabolising system (S9-mix from Arocior 1254 pre-treated rats) and was also not mutagenic in the preincubation method according to Frivol, Reaktiv-Orange FD 19969 FW induced chromosome mutations (aberrations) in V79 Chinese hamster cells both in the presence as well as in the absence of a metabolic activation system. However, a micronucleus-test has not shown any indications of chromosome mutations under condition in vivo.
Based on the results of a subacute (28-day) oral toxicity study, daily administration of doses up to 1 000 mg/kg body weight to rats has not caused compound-related lethality. Beside orange faeces indicating the excretion of Reaktiv-Orange FD 19969 FW in unchanged form, no side effects occurred. Body weight development, haematological and clinical chemistry parameters as well as organ weights were unaffected. Macroscopical and histo-pathological examinations have not revealed a compound-related effect. Thus the 'No observed Adverse Effect Level' (NOAEL) was 1000 mg/kg body weight per day.
Evaluation and Assessment:
Based on all available data, Reaktiv-Orange FD 19969 FW does not exhibit a conspicuous toxicokinetic behaviour. Reaktiv-Orange FD 19969 FW has a very low acute and systemic toxic potential. The results from all studies with dermal exposure indicates that Reaktiv-Orange FD 19969 FW has insignificant or no dermal absorptive potential. Additionally, taking the results of the subacute oral toxicity study into account, Reaktiv-Orange FD 19969 FW seems not to be absorbed from the gastrointestinal tract and therefore a significant bioaccumulation potential can be excluded. From the mutagenicity assays it appears that Reaktiv-Orange has some clastogenic potential. However, a positive response was only seen in vitro whereas under conditions in vivo no chromosome mutation occurred. Since Reaktiv-Orange FD 19969 FW is not expected to be absorbed from the gastrointestinal tract, this suspected clastogenic potential most likely does not represent a significant risk under conditions in vivo. This view is also supported by the negative micronucleus-test.
Summary:
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Reaktiv-Orange FD 19969 FW. The data indicate that there is little or no dermal absorptive potential. Likewise, the data from the subacute oral toxicity study are not indicative of a significant uptake of Reaktiv-Orange FD 19969 FW from the gastrointestinal tract. Thus, a major systemic burden is not to be expected pointing also to low or lacking bioaccumulation properties. Although from limited in vitro studies a clastogenic potential of Reaktiv-Orange FD 19969 FW must be assumed, a significant risk under conditions in vivo can be excluded because of the very low or lacking systemic uptake of Reaktiv-Orange FD 19969 FW as demonstrated in the subacute oral toxicity study and further supported by the negative micronucleus-test.
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