Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 947-990-9 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Data waiving:
- study waived due to provisions of other regulation
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The study does not need to be conducted because the majority of the tonnage is used in cosmetic end products. Consequently, the tonnage used for products other than cosmetics is far below 10 t/a and for that use alone a fish test would not be required (acc. to Annex VII).
According to the Cosmetics Regulation 1223/2009, any animal testing in cosmetic products or cosmetic raw materials cannot be conducted in the EU as of 11th September 2014 and cosmetics tested in animals, or whose ingredients have been tested on animals, cannot be placed in the EU market as of 11th March 2013. ECHA (REACH Factsheet, Interface between REACH and Cosmetics regulations, https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf) states that animal testing can be performed for all environmental endpoints established by REACH (whether or not the substance is only used for cosmetic purposes), but only as a last resort. It is not considered likely that a fish test would change the overall environmental risk of Yoghurt Powder (see CSR).
In addition, a search was conducted on the fish toxicity of the main components of Bos taurus milk, skimmed, fermented, spray-dried:
- data exist for lactic acid (CAS 50-21-5, registration dossier): LC50 (Fisch) = 130 mg/L, LC50 daphnia: 130 mg/L; algae EC50: 3.5 g/L = 3500 mg/L, however, these data do not lead to a classification of lactic acid, and furthermore, lactic acid is present in Bos taurus milk, skimmed, fermented, spray-dried only at max. 4.9%
- Lactose is exempted from REACH registration requirements according to REACH Annex IV (substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties) and can thus be considered to have non-critical properties)
- No fish toxicity data were found for milk proteins (e.g. peptones, casein (CAS-Nr. 91079-40-2) registration dossier)
- Hence, it was considered to conduct a QSAR for the milk proteins. However, Casein has appr. 200 amino acids, and even if a smaller form of casein could be used, e.g. https://pubchem.ncbi.nlm.
nih.gov/compound/73995022#section=Top (ca. 20 amino acids, MW > 2000 g/mol), the EPIweb ECOSAR tool is limited to a maximum of 1000 g/mol. Smaller proteins were not considered
representative. Hence, milk proteins were out of scope of the QSAR and no calculation could be conducted.
- Milk powder is a common ingredient in diverse fish feeding products. Hence, also Bos taurus milk, skimmed, fermented, spray-dried, which is similar, will not be toxic to fish.
=> Based on these data and the argumentation above, it was considered that an acute fish test does not have to be conducted.
Reference
Description of key information
Based on the collected data and the given argumentation, it was considered that an acute fish test does not have to be conducted.
Key value for chemical safety assessment
Additional information
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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