Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 441-100-8 | CAS number: 351197-46-1
- 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
Key value for chemical safety assessment
Effects on fertility
Additional information
According to Annex IX 8.7.3 a two-generation reproductive toxicity study has to be conducted for one species, male and female, for the most appropriate route of administration, having regard to the likely route of human exposure, if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. In the 28 day repeated oral dose study, epididymides, mammary gland, ovaries, prostate gland, seminal vesicles, testes, urinary bladder, uterus and vagina had been examined by macroscopy and microscopy and the organ weights of ovaries, testes and epididymides had been determined. There were no specific adverse effects observed on these tissues or reproductive organs. Therefore further testing for reproductive toxicity was not concerned to be necessary in terms of animal welfare.
Effects on developmental toxicity
Additional information
Directive 86/609/EEC stipulates that it is necessary to replace, reduce or refine testing on vertebrate animals. Regulation (EC) No. 1907/2006, Article 25, § 1 reinforces this by stating that the duplication of tests on vertebrates should be limited in particular with reference to the protection and welfare of animals. Hence, considering that the tonnage band of UAX-1179 is expected to increase in the near future from 10-100 t to 100-1000 t and in accordance also with Annex I § 0.5 (last paragraph), we consider that further information other than the 28d screening according to OECD guideline 421 study is necessary for producing an accurate chemical safety report with a accurately derived DNEL, which is sustainable for the higher tonnage levels (REGULATION (EC) No 1907/2006, Annex IX). This information can only be obtained by performing tests in accordance with Annex IX, thus it is proposed to perform a prenatal developmental toxicity study according to OECD guideline 414 rather than the 28 d screening study for reproductive/developmental toxicity (OECD 421). In the mean time interim risk management measures had been considered to manage the risks in relation to this endpoint.
Justification for classification or non-classification
According to DSD (67/548/EEC) and CLP (1272/2008/EC) UAX-1179 does not need meet the criteria to be classified regarding this endpoint.
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.
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.