Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 449-360-4 | CAS number: 647828-16-8
- 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
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In vivo screening for screening for reproductive / developmental toxicity: rat, (OECD TG 421, GLP).
- Systemic NOAEL: > 64 and 83 mg/kg bw/day for males and females, respectively
- Fertility NOAEL: >64 and 81 mg/kg bw/day for males and females, respectively,
- Development NOAEL: 81 mg/kg bw/day
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 64 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- An oral reproscreening study (OECD TG 421, GLP) is available. This study adequately covers this endpoint.
Additional information
Screening for Reproduction/ Developmental Toxicity - OECD TG 421 - Fertility and Developmental toxicity
In a reproduction/developmental toxicity screening test that was performed according to OECD TG 421 and under GLP conditions, 12 Wistar rats/sex/dose received diets containing the test substance at concentrations of 0, 15, 50 and 150 mg/kg bw (0, 225, 750 or 1500 mg/kg diet) during a premating period of 2 weeks and during mating (1 week), gestation and lactation until postnatal day 4. The test substance was homogeneously distributed in the diets and stable in diet stored in an open container for 24 hours, except for the high-dose level (-11 %). When stored in a closed container in the freezer (< -18°C), the high dose of the test substance in diet was stable for 5 weeks. The concentration of the test substance was lower than intended in all diets. Relative differences of -28 %, -26 % and -14 % were observed for the measured concentrations in the low-, the mid- and the high dose group, respectively.
Results: Daily clinical observations did not reveal any treatment-related changes in the animal's appearance, general condition or behaviour. No treatment-related effects were observed in mean body weight, body weight changes and food consumption throughout the study. Relative liver weight was statistically significant increased with 10.6 and 12.7% in mid dose and high dose males, respectively, but not in females. The toxicological relevance of this finding is doubtful, because there was no clear dose-response and no histopathological changes in the liver were observed. Macroscopic and microscopic examination of organs did not reveal any treatment-related changes. No treatment-related effects were observed on pre-coital time, mating index, female fecundity index, male and female fertility indices, gestation index, duration of gestation, number of corpora lutea, implantation sites, lost implantations and the calculated indices, pre- and post implantation loss. No effects were observed on litter size, pup sex and weight and pup survival. Macroscopic observations of stillborn pups or pups that died during lactation did not reveal any treatment-related changes.
Conclusion: The results of the reproduction/developmental toxicity screening test in rats indicate no systemic, fertility, and developmental toxicity up to and including the highest dose tested 100 mg/kg bw (1500 mg/kg diet, nominal concentration). In male rats, the NOAEL for systemic toxicity and fertility was established to be at least 64 mg/kg bw/day based on the actual dose of test substance ingested. In female rats, the NOAEL for systemic toxicity was established to be at least 83 mg/kg bw/day and the NOAEL for fertility and development was at least 81 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
For the test substance a Reproduction/ developmental toxicity screening test (OECD TG 421 in compliance with GLP) is available in which no maternal systemic and developmental effects were observed resulting in NOAELs for systemic and developmental toxicity of >=80 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 81 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A GLP compliant oral reproscreening study (OECD 421) is available and this study adequately covers this endpoint for this tonnage level
Justification for classification or non-classification
The substance does not have to be classified for toxicity to reproduction toxicity (both fertility and development) according to EU CLP (EC No. 1272/2008 and its amendments)
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.