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Diss Factsheets
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EC number: 431-060-1 | CAS number: 153719-38-1
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
Additional information
In a dose range finding feeding study (Syngenta 2001; 0, 50, 500, 2000, and 4000 ppm), toxicity was observed in parental animals at 2000 and 4000 ppm. Effects in offspring (viability, body weight gain) were seen only at levels where maternal toxicity was observed.
In a subsequent one generation reproductive toxicity study (RCC, 2002; OECD 415; 0, 50, 200, 600, and 2000 ppm) no effects on the reproductive performance were seen. General toxicity was reported for parents and offspring at 2000 ppm (reduced body weight gain). Since no effects in offspring were seen at levels below maternal toxicity and since no reproductive effects were seen in F0 animals below the LOAEL for general toxicity, the substance is not considered toxic to reproduction. However, German Competent Authority criticized that the maternal effects occurred only during (pre)mating and gestation and not during lactation, while the effects in pups occurred during lactation, only (BAuA, 27.05.2003; reference number: 99 04 1142 00). This was interpreted as a potential indication of an adverse developmental effect. In addition the food consumption in both studies led to different doses. For clarification the German Competent Authority requested an additional study and suggested application by gavage.
The requested one generation reproduction toxicity study (OECD 415, Harlan, 2009) was conducted by gavage (0, 50, 150, and 500 mg/kg bw/d). The LOAEL in F0 was 150 mg/kg bw/d based on general toxicity. Reproductive effects occur at 500 mg/kg bw/d (lower number of implantations, litter size and post-natal loss). Pups weight in the 150 mg/kg bw/d group was reduced. This effect was attributed to maternal toxicity. Hence there is no indication of toxicity to reproduction under conditions of a one generation (OECD 415) study.
In accordance with the request from the German Competent Authority (BAuA, 27.05.2003; reference number: 99 04 1142 00) no additional studies (OECD 416 and/or OECD 414) need to be conducted as the result of the OECD 415-study does not indicate effects on fertility.
Short description of key information:
Initially a dose range finding study (Syngenta, 2001) and a subsequent one generation feeding study (OECD 415; RCC, 2002) have been conducted. On request of the German competent authority (BAuA, 27.05.2003; reference number: 99 04 1142 00) a second one-generation study (OECD 415; gavage; Harlan, 2009) was conducted. Effects on development and fertility occur at 150 and 500 mg/kg bw/d, respectively, and have been attributed to maternal toxicity.
Effects on developmental toxicity
Description of key information
see above (fertility)
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
Additional information
see above (fertility)
Justification for classification or non-classification
Effects on development and fertility occur at 150 and 500 mg/kg/d, respectively, and have been attributed to maternal toxicity. Hence, no classification for reproductive effects is warranted.
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.
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