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EC number: 217-682-2 | CAS number: 1929-82-4
- 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
Carcinogenicity
Administrative data
Description of key information
Yano et al. (2008) reported the results of a two-year dietary oncogenicity study in B6C3F1 Mice. Here, the NOEL for carcinogenicity was cited to be 75 mg/kg bw/day with no increase in the incidence of neoplasms for treated animals. Furthermore, Yano et al. (2008) reported the results of a second two-year dietary oncogenicity study in B6C3F1 mice which was conducted using higher dose levels. This study identified liver, stomach, epididymal and Harderian gland tumors. In order to assess the relevance of these findings for human risk assessment, a Scientific Advisory Group (SAG) examined relevant microscopic changes in these tissues and also evaluated genotoxicity and mechanistic data. The consensus of the SAG was that the test item acted via a nongenotoxic-cytotoxic mode of action in the forestomach and liver. Thus, exposure conditions do not produce similar target organ toxicity in exposed individuals and thus would not be expected to increase the risk of cancer.
The US-EPA RED (2005) document reports the results of a two year chronic toxicity and oncogenicity study in Fischer 344 rats. The NOAEL and the LOAEL for toxicity were determined to be 5 and 20 mg/kg bw/day, respectively. At 20 mg/kg bw/day an increase in kidney tumors related to the alpha-2µ-globulin model were observed which are regarded as not relevant to humans.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Authorative secondary source with limited information provided. Original study report was not available.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.4300 (Combined Chronic Toxicity / Carcinogenicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Dose descriptor:
- LOAEL
- Effect level:
- 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Based on decreased body weight gain in males. Increase in kidney tumors related to the alpha 2µ globulin model (not relevant to humans).
- Remarks on result:
- other: Effect type: toxicity (migrated information)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 125 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Authorative secondary source with dose decriptor provided only. Original study report was not available.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available information are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result and according to the harmonised Annex I classification the substance is not considered to be classified for carcinogenicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available information are considered reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result and according to the harmonised Annex VI classification the substance is not considered to be classified for carcinogenicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
Additional information
Repeated dose toxicity oral:
The results of three oncogenicity studies using the oral route of administration were cited in peer reviewed and authorative secondary sources with no or very limited information on methodology provided.
Yano et al. (2008) reported the results of a two-year dietary oncogenicity study in B6C3F1 mice using the following dose levels: 0, 5, 25 or 75 mg/kg/day. The NOEL for carcinogenicity was cited to be 75 mg/kg bw/day with no increase in the incidence of neoplasms for treated animals.
Furthermore, Yano et al. (2008) reported the results of a second two-year dietary oncogenicity study in B6C3F1 mice which was conducted using higher dose levels: 0, 125 or 250 mg/kg/day. This study identified liver, stomach, epididymal and Harderian gland tumors.
In order to assess the relevance of these findings for human risk assessment, a Scientific Advisory Group (SAG) examined relevant microscopic changes in these tissues and also evaluated genotoxicity and mechanistic data. The consensus of the SAG was that the test item acted via a nongenotoxic-cytotoxic mode of action in the forestomach and liver. Thus, exposure conditions do not produce similar target organ toxicity in exposed individuals and thus would not be expected to increase the risk of cancer.
The US-EPA RED (2005) document reports the results of a two year chronic toxicity and oncogenicity study in Fischer 344 rats. The NOAEL and the LOAEL for toxicity were determined to be 5 and 20 mg/kg bw/day, respectively. At 20 mg/kg bw/day an increase in kidney tumors related to the alpha 2µ globulin model were observed (not relevant to humans).
In conclusion, nitrapyrin was considered not to have mutagenic or genetic toxicity concern.
Justification for selection of carcinogenicity via oral route endpoint:
Most recent study using highest testing doses.
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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