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Diss Factsheets
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EC number: 471-920-1 | 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
There is one key screening study for reproductive effects.
An OECD Guideline No. 421 study was conducted to generate limited information concerning the effects of the test article on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of the conceptus, and parturition. Four treatment groups of twelve CD® [Crl:CD®(SD)] rats/sex/group were administered the test article at dose levels of 100, 300, 600, or 1000 mg/kg/day at dose volumes of 0.4, 1.2, 2.4, or 4.0 mL/kg, respectively. One additional group of twelve animals/sex served as the control and received the vehicle, peanut oil (arachis oil NF) at a dose volume of 4.0 mL/kg. The vehicle or test article was administered to all groups once daily via oral gavage. The males were dosed for 43 days, beginning 14 days prior to pairing. Dosing of the females began 14 days prior to pairing, through the mating period, up to and including Lactation Day (LD) 3.
Observations of the parental (P0) animals included clinical signs, body weights and body weight change, and food consumption during the premating/mating, gestation, and lactation periods, and parturition and litter data. Observations of the offspring (F1) included survival at birth and during lactation, individual pup body weights, and gross abnormalities. At study termination, necropsy examinations were performed on all P0 animals, and organs and tissues were collected, weighed and examined for select groups. On LD 4, surviving F1 pups were examined externally, euthanized, and discarded.
The analytical evaluation of the formulation samples confirmed that they were homogenous and at the targeted concentration required. Control samples were devoid of test article.
Oral administration of the test article to male and female rats at 100, 300, 600, and 1000 mg/kg/day in males during the premating/mating and postmating periods did not reveal any test article-related changes. This included parameters consisting of P0 clinical findings, body weight, body weight change, and food consumption. In addition, reproductive, fertility, parturition, and F1 litter data, including external pup observations, as well as P0 gross necropsy findings, organ weights, and microscopic findings did not reveal any changes that could be considered treatment related.
Based on the results obtained from this oral reproductive/developmental toxicity screening study in rats, a No-Observed-Adverse-Effect-Level (NOAEL) for general, reproductive, and developmental toxicity was considered to be 1000 mg/kg/day, the highest level tested and the limit dose designated by the guideline.
Short description of key information:
The No-Observed-Adverse-Effect-Level (NOAEL) for general, reproductive, and developmental toxicity was considered to be 1000 mg/kg/day, the highest level tested and the limit dose designated by the guideline
Effects on developmental toxicity
Description of key information
The No-Observed-Adverse-Effect-Level (NOAEL) for general, reproductive, and developmental toxicity was considered to be 1000 mg/kg/day, the highest level tested and the limit dose designated by the guideline
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
There is one key screening study for reproductive effects.
An OECD Guideline No. 421 study was conducted to generate limited information concerning the effects of the test article on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of the conceptus, and parturition. Four treatment groups of twelve CD® [Crl:CD®(SD)] rats/sex/group were administered the test article at dose levels of 100, 300, 600, or 1000 mg/kg/day at dose volumes of 0.4, 1.2, 2.4, or 4.0 mL/kg, respectively. One additional group of twelve animals/sex served as the control and received the vehicle, peanut oil (arachis oil NF) at a dose volume of 4.0 mL/kg. The vehicle or test article was administered to all groups once daily via oral gavage. The males were dosed for 43 days, beginning 14 days prior to pairing. Dosing of the females began 14 days prior to pairing, through the mating period, up to and including Lactation Day (LD) 3.
Observations of the parental (P0) animals included clinical signs, body weights and body weight change, and food consumption during the premating/mating, gestation, and lactation periods, and parturition and litter data. Observations of the offspring (F1) included survival at birth and during lactation, individual pup body weights, and gross abnormalities. At study termination, necropsy examinations were performed on all P0 animals, and organs and tissues were collected, weighed and examined for select groups. On LD 4, surviving F1 pups were examined externally, euthanized, and discarded.
The analytical evaluation of the formulation samples confirmed that they were homogenous and at the targeted concentration required. Control samples were devoid of test article.
Oral administration of the test article to male and female rats at 100, 300, 600, and 1000 mg/kg/day in males during the premating/mating and postmating periods did not reveal any test article-related changes. This included parameters consisting of P0 clinical findings, body weight, body weight change, and food consumption. In addition, reproductive, fertility, parturition, and F1 litter data, including external pup observations, as well as P0 gross necropsy findings, organ weights, and microscopic findings did not reveal any changes that could be considered treatment related.
Based on the results obtained from this oral reproductive/developmental toxicity screening study in rats, a No-Observed-Adverse-Effect-Level (NOAEL) for general, reproductive, and developmental toxicity was considered to be 1000 mg/kg/day, the highest level tested and the limit dose designated by the guideline.
Justification for classification or non-classification
In accordance with CLP EC Regulation No. 1272/2008, the test material is not classified for reproductive toxicity in the absence of effects at the maximum dose concentration.
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.
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