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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 457-320-2 | 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
Endpoint summary
Administrative data
Description of key information
The subacute oral NOAEL is 300 mg/kg bw/day.
The subacute dermal NOAEL is 670 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 670 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
No treatment-related systemic adverse effects were seen in a GLP 28-day repeated-dose dermal toxicity study of a substance structurally and chemically similar to EC# 457-320-2. The top dose used was 1,000 mg test material/kg bw/day, and the test material comprised 67% active substance. The NOAEL for systemic effects was therefore 670 mg/kg bw/day. (The NOAEL for local dermal irritation effects was 2 mL/kg of 5% solution, or 100 mg/kg bw/day).
No treatment-related systemic adverse effects were seen in a GLP 28-day repeated-dose oral toxicity study of the same substance structurally and chemically similar to EC# 457-320-2. An increase in liver weight was seen in treated animals, but there was no associated histopathology and the study personnel did not consider it to be a toxicologically-significant effect. The NOAEL was therefore 1,000 mg/kg bw/day, the top dose used.
A reproduction/developmental toxicity screening study in which EC# 457-320-2 was orally administered to male and female rats for up to 28 (males) or 45 (females) days at doses of 100, 300 and 1000 mg/kg bw/day is also available. Adverse behaviour/CNS-related findings of intermittent tremors, repetitive movement of mouth and jaws, excessive pawing and/or licking of the cage floor and/or walls (females only, beginning on study day 13), and/or head twitch were noted in the 1000 mg/kg bw/day animals. An increase in liver weight was also seen in 1000 mg/kg bw/day females. Based on these effects, the NOAEL was concluded to be 300 mg/kg bw/day.
Overall, therefore, the subacute repeat-dose oral NOAEL for EC# 457-320-2 is concluded to be 300 mg/kg bw/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) neurologic: behaviour; neurologic: central nervous system
Justification for classification or non-classification
No treatment-related systemic toxicity was seen in the 28-day dermal toxicity study of a substance structurally and chemically similar to EC# 457-320-2, and the NOAEL was concluded to be 670 mg/kg bw/day. No hazard classifications are required based on this study.
The two repeat-dose oral studies available (28-day toxicity study and a reproduction/developmental toxicity screening study) identifed no consistent identifiable treatment-related toxic effects at dose levels that might necessitate classification for Specific Target Organ Toxicity (STOT-RE). Consequently, in accordance with CLP, no hazard classifications are proposed.
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.