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EC number: 213-116-3 | CAS number: 925-21-3
- 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
Description of key information
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 175 mg/kg bw/day
- Study duration:
- subacute
- 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
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 175 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone.
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 175 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone.
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Justification for classification or non-classification
Based on the results of the above study the test material can be considered not to be classified for reproduction and developmental toxicity.
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.