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EC number: 444-860-9 | CAS number: 474510-57-1
- 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
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 30 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 purpose of this study was to generate information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition. The test item was administered orally by gavage to male rats at concentrations of 10, 30 and 90 mg/kg bw/day for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.
All pairs mated. Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item. Mean number of corpora lutea and implantations per dam and the post-implantation loss were not affected by the treatment with the test item. The mean postnatal loss between days 0 and 4 post partum was higher and the mean number of living pup on day 4 post partum were lower consequently the viability index was statistically significantly lower in the high dose group therefore these were considered to be test item-related effects. No histological evidence of toxicological properties in the reproductive organs and tissues examined were detected at 90 mg/kg body weight/day.
Short description of key information:
An OECD 422 study was performed to generate information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition. The test item was administered orally by gavage to male rats at concentrations of 10, 30 and 90 mg/kg bw/day for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item. Mean number of corpora lutea and implantations per dam and the post-implantation loss were not affected by the treatment with the test item.
Effects on developmental toxicity
Description of key information
An OECD 422 study was performed to generate information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition. The test item was administered orally by gavage to male rats at concentrations of 10, 30 and 90 mg/kg bw/day for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Based on the significantly lower body weight of pups and the decreased viability index on day 4 post partum at the high dose level of 90 mg/kg body weight/day, the NOAEL for reproduction/ developmental toxicity was considered to be 30 mg/kg body weight/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
The purpose of this study was to generate information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition. The test item was administered orally by gavage to male rats at concentrations of 10, 30 and 90 mg/kg bw/day for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.
The mean litter size of dams receiving 90 mg/kg body weight/day was slightly lower when compaired to controls. Mean postnatal loss between days 0 and 4 post partum was higher and the mean number of living pup on day 4 post partum was lower in the group receiving 90 mg/kg body weight/day. The sex ratio was not affected. No abnormal pup was noted at any dose level. At the dose level of 90 mg/kg body weight/day, three male pups in three different litters (nos. 72, 74, 79) had no milk in stomach at first litter check and they were missing afterwards on days 4, 2, 2 post partum, respectively.
Mean pup weights on day 1 post partum were unaffected, whereas, the mean body weight of pups on day 4 post partum (dose level of 90 mg/kg body weight/day) was significantly lower and therefore considered to be a test item-related effect. At necropsy of pups, there were no abnormal findings noted.
Based on the significantly lower body weight of pups and the decreased viability index on day 4 post partum at the high dose level of 90 mg/kg body weight/day, the NOAEL for reproduction/ developmental toxicity was considered to be 30 mg/kg body weight/day.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for reproductive toxicity under Directive 67 / 548 / EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.
Additional information
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