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EC number: 288-470-5 | CAS number: 85736-59-0
- 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
The source substance naphthenic acids has been investigated for skin sensitisation properties in an in vivo OECD 406 Guinea pig maximisation test (Yamato et al., 2006). The results did indicate that naphthenic acids were positive in the guinea pig maximisation test.
Thus, it can be concluded, that although the bismuth(III) cation will not cause skin sensitisation, the naphthenic acids are considered skin sensitising. Taking into account that naphthenic acids, bismuth salts are manufactured with a slight excess of naphthenic acids (to ensure tri-substitution), excess naphthenic acids will be present in the UVCB substance and thus the target substance naphthenic acids, bismuth salts is considered being a skin sensitiser, accordingly.
Considering the low vapour pressure (< 1 Pa) of the substance and its use in heavy duty industrial grease, not applied as aerosols, respiratory sensitisation is not considered critical due to lack of exposure routes.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- read across from GPMT and LLNA study
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The substance naphthenic acids, bismuth salts is manufactured from bismuth oxide/hydroxide and 3 equivalents of naphthenic acids, resulting in the bismuth tri-naphthenate. Thus, to assess skin sensitisation properties, results for bismuth 3+ cations were assessed as well as data for naphthenic acids, the two potential hydrolysis products of the substance. The undissociated substance is considered uncritical, as its molecular mass of ~850 Dalton makes it unlikely that such compounds efficiently pass biological membranes or skin. Thus, the skin sensitisation potential of naphthenic acids, bismuth salts will be dominated by its ions, derived from hydrolysis upon contact with moist skin. In addition, pH effects are considered uncritical as naphthenic acids being typically weak acids and bismuth hydroxide, a weak base do form almost neutral neutralisation products, thus not affecting the skin barrier via pH effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source compound naphthenic acids is the starting material for the manufacturing of naphthenic acids, bismuth salts. Naphthenic acids do contain mainly hydrocarbon acids with a carbon range from 10 - 15 (other naphthenic acids may have wider ranges), with a variable number of cyclics contained (n = 0, 1, 2 and rarely 3). To a minor extent also aliphatics may be present as minor "impurities".
The naphthenic acids are reacted in a slight excess of >3 equivalents of naphthenic acids with bismuth oxide to derive naphthenic acids, bismuth salts with a slight excess of naphthenic acids, the target substance. Thus, the starting compound for the synthesis of the target compound is actually the source substance. Whereas the bismuth oxide used has a purity of 99% by weight typically, not capable of passing the human skin, the naphthenic acids, being a UVCB-type substance, are of 100% purity, by definition.
To assess the skin sensitisation potential of bismuth compounds, a soluble form, namely bismuth hydroxy nitrate oxide, has been tested in a LLNA study for skin sensitisation properties and was found negative, proving that even elevated amounts of Bi(III) cations are not capable of causing skin sensitisation.
3. ANALOGUE APPROACH JUSTIFICATION
The target substance naphthenic acids, bismuth salts, containing mainly bismuth tris-naphthenate, has a huge molecular weight (~ 850 Dalton) and it is known that such substance can hardly pass human skin, causing irritation or sensitisation effects. Also, the pH of such compounds, consisting of the neutralisation product of a weak base (bismuth hydroxide) and a weak acid (naphthenic acids) is expected being neutral, and experience in production and use does confirm this. Even the slight excess of naphthenic acids, used in production to shift the reaction towards tri-substitution, does not change the pH significantly. As a result, it is assumed that the skin barrier remains intact upon exposure.
However, it is expected that the slight excess of naphthenic acids, used to shift the reaction towards tri-substitution, will mainly determine the skin sensitisation potential of the UVCB substance, and naphthenic acids, due to a much smaller molecular size will be potentially capable of passing human skin. Thus, the focus for assessing skin sensitisation will be on naphthenic acids. Bismuth hydroxide nitrate oxide at concentrations of 10%, 25% or 50% (w/w) in acetone/olive oil (3+1, v/v) did not reveal any sensitising properties in the local lymph node assay, and therefore even soluble bismuth(III) compounds are not leading to skin sensitisation.
The source substance naphthenic acids has been investigated for skin sensitisation properties in an in vivo OECD 406 Guinea pig maximisation test (Yamato et al., 2006). The results did indicate that naphthenic acids were positive in the guinea pig maximisation test.
Thus, it can be concluded, that although the bismuth(III) cation will not cause skin sensitisation, the naphthenic acids are considered skin sensitising. Taking into account that naphthenic acids, bismuth salts are manufactured with a slight excess of naphthenic acids (to ensure tri-substitution), excess naphthenic acids will be present in the UVCB substance and thus the target substance naphthenic acids, bismuth salts is considered being a skin sensitiser.
4. DATA MATRIX
The source substances naphthenic acids and bismuth hydroxy nitrate oxide were assessed in studies to investigate skin sensitisation properties; the bismuth compound in an in vivo local lymph node assay and the naphthenic acids in an in vivo guinea pig maximisation test (OECD 406). Whereas the soluble bismuth 3+ form was found negative for skin sensitisation, the naphthenic acids showed clearly skin sensitising effects.
Considering that the target substance consists of approx. 90% bismuth tri-naphthenates and a slight excess of free naphthenic acids (~10%) it is clear that the skin sensitising effect of naphthenic acids is relevant for classification and labelling as well as risk assessment of the target substance naphthenic acids, bismuth salts, being considered as a skin sensitiser, accordingly.
In conclusion, the naphthenic acids, bismuth salts are considered as skin sensitiser, category 1 according to CLP (Regulation EC No 1272/2008). - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: not reported in publication, but due to positive results not considered critical.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on data from naphthenic acids, that target substance naphthenic acids, bismuth salts is considered being a skin sensitiser.
- Executive summary:
The source substance naphthenic acids has been investigated for skin sensitisation properties in an in vivo OECD 406 Guinea pig maximisation test (Yamato et al., 2006). The results did indicate that naphthenic acids were positive in the guinea pig maximisation test.
Thus, it can be concluded, that although the bismuth(III) cation will not cause skin sensitisation, the naphthenic acids are considered skin sensitising. Taking into account that naphthenic acids, bismuth salts are manufactured with a slight excess of naphthenic acids (to ensure tri-substitution), excess naphthenic acids will be present in the UVCB substance and thus the target substance naphthenic acids, bismuth salts is considered being a skin sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on skin sensitising properties attributable to naphthenic acids, the substance naphthenic acids, bismuth salts is classifed as skin sensitising, category 1 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.
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