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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 429-280-6 | CAS number: 151900-44-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No local or systemic toxicity was observed in a subacute repeated dose toxicity study after oral application; consequently route-to-route extrapoation is appropriate
- AF for dose response relationship:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for differences in duration of exposure:
- 6
- Justification:
- default sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the derivation of the dose desciptor starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no indication that this "additional uncertainty" is appropriate for this compound. Nevertheless the default factor is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for remaining uncertainties:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 188 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Limit for peak exposure is based on the long-term DNEL and a peak-exposure factor; see justification
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No local or systemic toxicity was observed in a subacute repeated dose toxicity study after oral application; consequently route-to-route extrapoation is appropriate
- AF for dose response relationship:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for differences in duration of exposure:
- 6
- Justification:
- default sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no indication that this "additional uncertainty" is appropriate for this compound. Nevertheless the default factor is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for remaining uncertainties:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 27 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Limit for peak exposure is based on the long-term DNEL and a peak-exposure factor; see justification
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The derived DNEL cover also the endpoints fertility and development.
Fertility: The sub-acute toxicity study with Vulcuren (99.7%) (Bayer AG 2000d) did not reveal any evidence of an adverse effect to the reproductive organs up to the highest dose tested (1000 mg/kg body weight and day). As confirmed by literature (Mangelsdorf et al. 2003, Ulbrich & Palmer 1995, Janer et al. 2007 and Dent 2007) histopathological examinations in repeated dose toxicity are of high value and high sensitivity for the evaluation of reproductive toxicity. Therefore at least for fertility assessment a repeated dose toxicity study showing no adverse effect should be taken into account. Also it is agreed that histopathological changes on the reproductive organs in repeated dose studies (subacute or longer exposure, see e.g. Ulbrich & Palmer 1995, Mangelsdorf et al. 2003) are indicative of effects on fertility. Therefore repeated dose toxicity studies is considered as sufficient information for a DNEL calculation for fertility if histological examination of the reproductive organs is covered by repeated dose toxicity studies and the mode of action of the test substance does not give evidence for a specific toxicity (which is not the case with Vulcuren (purity: 99.7%)). It is proposed by the group of researchers that in the absence of a two-generation study the NOAEL obtained from a subchronic study (or the lowest available studies) could be used as a reference point for deriving the DNEL (Janer at. al. 2007). Therefore, for Vulcuren (purity: 99.7%) the NOAEL (1000 mg/kg body weight and day) from the subacute toxicity study (Bayer AG 2000) could be used for DNEL derivation. No adverse effects on the reproduction organs were seen up to the highest dose group evaluated in male and female rats (1000 mg/kg body weight). Since the long-term DNEL is calculated from this study it covers systemic and fertility endpoints.
Development: A developmental toxicity study according to OECD TG 414 was conducted in rats. NOEL appearance of placentas: 300 mg/kg bw/day; an increased incidence of engorged placentas occurred at the 1000 mg/kg level in one litter, for which a treatment related effect cannot be excluded; NOAEL remaining developmental toxicity: 1000 mg/kg bw/day. Taking 300 mg/kg as a conservative and not necessarily adverse starting point for DNEL calculation and applying the default factors for a developmental toxicity study (interspecies differences: 4; additional uncertainty: 2.5; intra-species difference worker: 5; overall assessment factor of 50) a DNEL of 6 mg/kg could be derived for oral and dermal exposure. The corresponding inhalation DNEL would be 47 mg/m³. These DNEL are higher than the corresponding DNEL derived for systemic toxicity.
Therefore, for Vulcuren the DNELs derived for long-term exposure cover systemic toxicity, fertility and development.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No local or systemic toxicity was observed in a subacute repeated dose toxicity study after oral application; consequently route-to-route extrapoation is appropriate.
- AF for dose response relationship:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for differences in duration of exposure:
- 6
- Justification:
- default sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the derivation of the dose desciptor starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no indication that this "additional uncertainty" is appropriate for this compound. Nevertheless the default factor is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for remaining uncertainties:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No local or systemic toxicity was observed in a subacute repeated dose toxicity study after oral application; consequently route-to-route extrapoation is appropriate
- AF for dose response relationship:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for differences in duration of exposure:
- 6
- Justification:
- default sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- extrapolation from rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no indication that this "additional uncertainty" is appropriate for this compound. Nevertheless the default factor is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
- AF for remaining uncertainties:
- 1
- Justification:
- No toxicity was observed at the limit dose, a NOAEL is = 1000 mg/kg is conservative since no LOAEL can be established.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: DNEL were derived similar as dermal DNEL
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The derived DNEL covers also the endpoints fertility and development.
Fertility: The sub-acute toxicity study with Vulcuren (purity: 99.7%) (Bayer AG 2000d) did not reveal any evidence of an adverse effect to the reproductive organs up to the highest dose tested (1000 mg/kg body weight and day). As confirmed by literature (Mangelsdorf et al. 2003, Ulbrich & Palmer 1995, Janer et al. 2007 and Dent 2007) histopathological examinations in repeated dose toxicity are of high value and high sensitivity for the evaluation of reproductive toxicity. Therefore at least for fertility assessment a repeated dose toxicity study showing no adverse effect should be taken into account. Also it is agreed that histopathological changes on the reproductive organs in repeated dose studies (subacute or longer exposure, see e.g. Ulbrich & Palmer 1995, Mangelsdorf et al. 2003) are indicative of effects on fertility. Therefore repeated dose toxicity studies is considered as sufficient information for a DNEL calculation for fertility if histological examination of the reproductive organs is covered by repeated dose toxicity studies and the mode of action of the test substance does not give evidence for a specific toxicity (which is not the case with Vulcuren (purity: 99.7%)). It is proposed by the group of researchers that in the absence of a two-generation study the NOAEL obtained from a subchronic study (or the lowest available studies) could be used as a reference point for deriving the DNEL (Janer at. al. 2007). Therefore, for Vulcuren (purity: 99.7%) the NOAEL (1000 mg/kg body weight and day) from the subacute toxicity study (Bayer AG 2000) could be used for DNEL derivation. No adverse effects on the reproduction organs were seen up to the highest dose group evaluated in male and female rats (1000 mg/kg body weight). Since the long-term DNEL is calculated from this study it covers systemic and fertility endpoints.
Development: A developmental toxicity study according to OECD TG 414 was conducted in rats. NOEL appearance of placentas: 300 mg/kg bw/day; an increased incidence of engorged placentas occurred at the 1000 mg/kg level in one litter, for which a treatment related effect cannot be excluded; NOAEL remaining developmental toxicity: 1000 mg/kg bw/day. Taking 300 mg/kg as a conservative and not necessarily adverse starting point for DNEL calculation and applying the default factors for a developmental toxicity study (interspecies differences: 4; additional uncertainty: 2.5; intra-species difference worker: 10; overall assessment factor of 100) a DNEL of 3 mg/kg could be derived for oral and dermal exposure. The corresponding inhalation DNEL would be 23.5 mg/m³ These DNEL are higher than the corresponding DNEL derived for systemic toxicity.
Therefore, for Vulcuren the DNELs derived for long-term exposure cover systemic toxicity, fertility and development.
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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