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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 700-810-0 | CAS number: 58190-62-8
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key study: Based on the read-across approach from the analogue substance MPKO, the NOAEL after at least 28 days of oral exposure was determined to be 18 mg/kg bw/day .
Key study: Based on the read-across approach from experimental results on analogue OS2200, the NOAEL for 13 weeks repeated dose toxicity by oral route in rats was estimated to be 13 mg/kg-bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (KIimish = 1) is available.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format and read-across rationale. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 13 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: red blood cell rate of turnover resulting in associated changes in the spleen.
- Remarks on result:
- other: Based on a read-across from an analogue substance for which NOAEL = 15 mg/kg-bw/day.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 45 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- blood
- spleen
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- Based on the read-across approach from the analogue substance OS2200, the sub-chronic NOAEL for OS2600 was determined to be 13 mg/kg bw/day for general systemic toxicity.
- Executive summary:
A 13 week repeated dose toxicity test followed by a 4 week recovery period was performed to assess the systemic toxicity of the analogue substance OS 2200 by the oral route in rats. It was concluded that the principal action of OS2200 was to affect the red blood cell rate of turnover occurring mainly among animals receiving 50 mg/kg/day, resulting in associated changes in the spleen. A dosage level of 15 mg/kg/day was considered the NOAEL for OS 2200. Based on the read-across approach from the analogue substance OS2200, the sub-chronic NOAEL for OS2600 was determined to be 13 mg/kg bw/day for general systemic toxicity.
Reference
The results from the read-across approach are expressed (calculated) on the basis of the molecular weight of OS2600 and OS2200 since the basic structures of the target and source substances are the same. No other adaptation is necessary.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 13 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- OECD guidance study conducted under GLP with a Klimisch score of 1 (since read-across, the Klimisch score is 2). The overall quality of the database was determined to be appropriate for assessment.
- System:
- haematopoietic
- Organ:
- blood
- kidney
- liver
- spleen
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key study: Read-across approach from experimental data on the analogue MPKO (RDT 28 days, oral, rats:
The systemic toxic potential and effects on reproduction were assessed in rats following oral administration for at least five weeks with recovery period of 14 days in accordance with OECD Guideline 422 (GLP study). Based on the read-across approach from the experimental data on the analogue substance MPKO, the hydrolysis product of OS2600 (NOAEL = 15 mg/kg bw/day, based on hematological changes associated with red blood cells destruction and associated microscopic findings (discoloration, hemosiderosis and extramedullary hematopoiesis) in spleen, liver or kidneys at dose levels of 50 and 150 mg/kg bw/day), the NOAEL for OS2600 was determined to be 18 mg/kg bw/day for subacute repeated dose toxicity by oral route and the observed adverse effects are expected at an estimated dose levels of 58 and 175 mg/kg bw/day.
Key study: Read-across from experimental data on the analogue OS2200 (RDT 90 days, rats)
A 13 week repeated dose toxicity test followed by a 4 week recovery period was performed to assess the systemic toxicity of the analogue substance OS 2200 by the oral route in rats. It was concluded that the principal action of OS2200 was to affect the red blood cell rate of turnover occurring mainly among animals receiving 50 mg/kg/day, resulting in associated changes in the spleen. A dosage level of 15 mg/kg/day was considered the NOAEL for OS2200. Based on the read-across approach from the analogue substance OS2200, the sub-chronic NOAEL for OS2600 was determined to be 13 mg/kg bw/day for general systemic toxicity.Nevertheless, it is important to notethe low severity of the observed effect (reductions of haemoglobin less than 10 % without marked organ disfunction) and the absence of persistence of the observed effects (reversibility within 4 weeks recovery-period).
Repeated dose toxicity: via oral route - systemic effects (target organ):
Hematological with associated changes in the spleen.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study with the longest duration (90-days) was chosen.
Justification for classification or non-classification
Based on a read-across the 13 weeks-NOAEL (oral, rat) was determined to be 13 mg/kg bw/day based on haematologic changes resulting in associated changes in the spleen observed at an estimated dose of 43 mg/kg bw/day. Nevertheless, given the low severity of this effect (reductions of haemoglobin less than 10 % without marked organ disfunction) and the absence of persistence of the observed effects (reversibility within 4 weeks recovery-period), the substance is not classified for STOT RE according to CLP Regulation (EC) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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