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EC number: 270-451-8 | CAS number: 68440-34-6
- 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
Additional information
Justification for Read-across
There are no data available for the biodegradation of Fatty acids, tallow, zinc salts (CAS No. 68440-34-0). In order to fulfil the standard information requirements set out in Annexes VII - IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances and from surrogate substances was conducted.
In accordance with Article 13(1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human and environmental toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity and common physiological active moieties.
Fatty acids, tallow, zinc salts consist of approximately 10% zinc and 90% natural fatty acids, mainly of saturated C16 and C18 fatty acids and monounsaturated C18 fatty acid.
In the case of Fatty acids, tallow, zinc salts, read-across to Fatty acids, zinc salts and to inorganic zinc salts and zinc metal (as listed below) was used. Justification for both approaches is given below.
Fatty acids, zinc salts
The target substances Fatty acids, tallow, zinc salts and the source substances Fatty acids, C16-18, zinc salts (CAS No. 91051-01-3), zinc distearate (CAS No. 557-05-1), zinc bis[12-hydroxystearate] (CAS No. 35674-68-1) and zinc dicaprylate (CAS No. 557-09-5) are substances with a zinc moiety and a fatty acid moiety. The zinc content is considered to be similar. The fatty acid moiety is considered not being hazardous to humans and the environment. Fatty acids are natural constituents of the human body and the environment and essential components of a balanced nutrition for humans and animals. Fatty acids are generally judged as not representing a risk to human health (except the irritating/corrosive properties of short-chain fatty acids and the environment. Variability in the poorly soluble fatty acid moiety is not expected to have a relevant influence on the physiological activity of fatty acid zinc salts and therefore, read-across to another fatty acid zinc salts is justified without restrictions.
Inorganic zinc salts
A basic assumption for read-across made in this hazard assessment and throughout this CSR is that the biological activities of Fatty acids, tallow, zinc salts are expected to be mainly determined by ionic zinc, in case of dissociation. Since water solubility is the main determinant of bioavailability, read-across to source substances with higher water solubility and thus higher bioavailability of the zinc cation can be considered as worst-case for the target substance fatty acids, tallow, zinc salts.
This read-across approach is in accordance with the read-across approach applied in the course of the EU Risk assessments within the framework of EU Existing Chemicals Regulation (EEC) No 793/93 on substances zinc metal (CAS No. 7440-66-6), zinc oxide (CAS No. 1314-13-2), zinc chloride (CAS No. 7646-85-7), zinc sulphate (CAS No. 7733-02-0), trizinc bis(orthophosphate) (CAS No. 7779-90-0) and the structural analogue to Fatty acids, tallow, zinc salts being zinc distearate (CAS No. 557-05-1 / 91051-01-3).
For a comprehensive overview of the environmental fate properties and environmental and toxicological information of “Zinc” see the Chemical Safety Assessment of "Zinc" within the framework of Regulation (EC) No 1907/2006 in the technical dossier (see IUCLID Section 13).
Overview of source and target chemicals including CAS No./EC No.
Chemical Name |
CAS No. / EC No. |
Target substance |
|
Fatty acids, tallow, zinc salts |
68440-34-6 / 270-451-8 |
Source substances |
|
Fatty acids, C14-18 and C16-18 unsatd., zinc salts |
67701-12-6 / |
Fatty acids, C16-18 and C18 unsatd., zinc salts |
67701-13-7 / 266-937-4 |
Fatty acids, C16-18, zinc salts |
91051-01-3 / |
Zinc distearate |
557-05-1 / |
Zinc bis[12-hydroxystearate] |
35674-68-1 / |
Zinc dicaprylate |
557-09-5 / |
Zinc diacetate |
557-34-6 / |
Zinc dichloride* |
7646-85-7 / 231-592-0 |
Zinc sulfate* |
7733-02-0 / |
Zinc nitrate* |
7779-88-6 / |
Zinc oxide* |
1314-13-2 / |
Zinc*# |
7440-66-6 / |
*) Surrogate substances (inorganic zinc salts)
#) The acceptance of zinc as surrogate refers to the cases where the specified CAS No. is given as test substance identity in the technical dossier with no further data on specification. In most cases this is presumably an ionic form, Zn2+.
A detailed read-across justification is provided in the technical dossier (see IUCLID Section 13).
Based on its physico-chemical properties the target compartments of Fatty acids, tallow, zinc salts in the environment would be soil and sediment. However, Fatty acids, tallow, zinc salts is readily biodegradable, poorly soluble in water and has potential to adsorb and is therefore expected to be eliminated in sewage treatment plants to a high extent. Significant release to surface waters and sediment is thus unlikely. In case of release, rapid elimination via biodegradation is also expected in aquatic and terrestrial environments.
An EU Risk Assessment Report is available for the structural analogue Zinc distearate (CAS No.: 557-05-1 and 91051-01-3.Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051-01-3 is a more exact fit with commercial zinc stearate, but it is only listed on EINECS and Chemical Abstracts have never indexed a single entry to this number. Based on these considerations, the CAS no 91051-01-3 was added. As stated in the Risk Assessment Report for Zinc distearate, Fatty acids, tallow, zinc salts is also assumed to partly dissociate into the zinc cation and the respective C16, C18 and C18:1 fatty acid anions, especially in an acidic environment (ECB, 2008). The further speciation of zinc, which includes complexation, precipitation and sorption, and the environmental fate of the fatty acids depend on the environmental conditions. In the presence of other cations such as calcium and magnesium, zinc distearate will partly form other “insoluble” fatty acid metal salts (e.g. Schmets, 1996). The fatty acids as such are readily biodegradable, although the degradability can be inhibited by the formation of insoluble salts (e.g. calcium, magnesium and zinc salts), that are not readily biodegradable (BKH, 1994; Schmets, 1996).
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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