Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 458-880-0 | 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- effects observed in a two generation reproduction toxicity study (sub-chronic exposure)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The two substances ADK STAB NA-11 (CAS no. 85209-91-2, EC no. 286-344-4) and ADK STAB NA-70 (CAS no. 85209-93-4, EC no. 458-880-0) have the same molecular structure, i.e. 2,4,8,10-tetra-tert-butyl-6-hydroxy-12H-dibenzo[d,g][1.3.2]-dioxaphosphocin-6-oxide. The substances only differ in the counter ion of the cyclic diarylphosphoric acid ester, i.e. sodium and lithium, respectively. Water solubility of NA-11 amounts to 1850 mg/l, that of NA-70 to 390 mg/l. Both substances dissociate at low concentration in aqueous environments.
With both substances, many toxicity studies were performed to determine their hazard potential. In short-term studies for determination of the hazard potential after single or short-term exposure, i.e. skin and eye irritation, skin sensitisation and systemic toxicity after single oral or dermal application, the two substances did not exhibit adverse effects. The LD50 after single oral or dermal exposure was > 2000 mg/kg body weight. In a study for acute inhalation toxicity performed with NA-70 (in powder form), at high concentrations acute toxicity was observed leading to classification for acute toxicity category 4.
In genetic toxicity tests, the two substances exhibited high cytotoxicity in mammalian cell cultures. Based on the results of in vitro and vivo tests, a genotoxic potential can be excluded. The results from these short-term tests confirm the expectation that the two different salts of the cyclic diarylphosphoric acid ester exhibit well comparable toxic properties.
In oral toxicity studies with repeated dosing, at high doses some toxic effects were observed with both substances. A detailed assessment of all toxicological data available on NA-11 and NA-70 and two other substances with the same chemical structure was performed. It was concluded that read-across from data obtained in studies performed with any of the substances is appropriate including the studies for reproduction and developmental toxicity performed with NA-11. See attached review.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached review
3. ANALOGUE APPROACH JUSTIFICATION
See attached review
4. DATA MATRIX
See attached review - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 000 - < 10 000 mg/kg diet
- Based on:
- test mat.
- Remarks:
- When corrected for mean substance intake, the NOAEL of 3000 ppm corresponds to 184-261 mg and 230-286 mg test substance per kg body weight per day for males and females, respectively. From these ranges the NOAEL is set at 200 mg/kg body weight/day.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- food efficiency
- other: food efficiency was strongly depressed in high dose animals; disruption of the gut microbiome by the antimicrobial activity of the test substance is very likely and could have caused the observed (secondary) effects.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10 000 mg/kg diet
- System:
- other: food efficiency was strongly depressed in high dose animals; disruption of the gut microbiome by the antimicrobial activity of the test substance is very likely and could have caused the observed (secondary) effects.
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- no
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- System:
- other: food efficiency was strongly depressed in high dose animals; disruption of the gut microbiome by the antimicrobial activity of the test substance is very likely and could have caused the observed (secondary) effects.
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
Justification for classification or non-classification
Based on the NOAEL of 200 mg/kg bw/day derived from the two generation reproduction toxicity study for sub-chronic oral exposure, NA-70 does not need to be classified regarding repeated dose toxicity according to REGULATION (EC) 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.