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Diss Factsheets
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EC number: 415-510-2 | CAS number: 145703-76-0
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity was assessed in rats of both sexes orally by gavage at concentrations of 0, 100, 300 and 1000 mg/kg bw/day using distilled water as vehicle. The treatment was administered for up to 51 - 54 days in both males and females, covering pre-mating, mating, gestation period of pregnant females and lactation up to 13 - 15 days post delivery. Then necropsy was performed on parental animals.
At all tested doses, no substance related effects on males fertility were noted.
At 1000 mg/kg bw/day, post-implantation losses were more frequent than in (test or historical) controls. Despite the low difference, a test item influence could not be excluded.Under the test conditions, the substance did not show effects on reproductive performance of male rats and NOAEL = 1000 mg/kg bw/day was established. Toxicity in terms of post-implantation losses was noted in female rats, with NOAEL = 300 mg/kg bw/day and LOAEL = 1000 mg/kg bw/day.
Short description of key information:
At high dosage (1000 mg/kg bw/day), the substance induces post-implantation losses higher than those encountered in both test control and historical control. Thus, NOAEL = 300 and LOAEL = 1000 mg/kg bw/day.
Justification for selection of Effect on fertility via oral route:
The study is reliable and representative.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In addition, at all tested doses, no substance related clinical signs were detected; no effects on survival indices, sex distribution and body weight were seen. Anogenital distance and nipple retention were similar in control and treated groups.
Justification for selection of Effect on developmental toxicity: via oral route:
The study is reliable and representative.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, adverse effects on developmental toxicity in the offspring and adverse effects on or via lactation.
Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans.
Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1.
Test substance did not show any evidence on reproductive toxicity in a screening test covering fertility, development and lactation. The only finding was an increase of post-implantation losses at high dose (1000 mg/kg bw/day) in rats. For this effect, a NOAEL was established at the mid dose of 300 mg/kg bw/day. On these bases, the substance is considered as non toxic for reproduction.
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.