Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 601-147-9 | CAS number: 111988-49-9
- 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
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:
- 122 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 18.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 9.15 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an inhalatory NOAEC observed in a subacute inhalation study (OECD 412, 1998). The NOAEC is corrected to account for differences between experimental and human exposure conditions. It is further corrected for the difference between respiratory rates under standard conditions and under conditions of light activity (sRVhuman versus wRV).
NOAECcorr = NOAEC*(6 h per day/8 h per day)*(6.7 m³ (8 h)/10 m³ (8 h))
NOAECcorr = 18.2 mg/m³ * 0.75 * 0.67 = 9.15 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEC.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a 28-day inhalation study with rats (exposed 6 h/day).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences were taken into account for the conversion of the rat NOAEC into a modified human NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 222 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 90
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a prenatal developmental toxicity study in rabbits (key, 1996). To convert the rabbit oral NOAEL into a corrected dermal NOAEL to assess human dermal exposure, the NOAEL has to be corrected as follows:
NOAELdermal = NOAELoral * (ABSoral-rabbit/ABSderm-human)
NOAELdermal = 2 mg/kg bw/day * (100/10) = 20 mg/kg bw/day
ABS = absorption
Dermal absorption is considered to be 1% when handling concentrated test substance or 10% when diluted (Thiacloprid 2004: Sanco/4347/2000). Oral absorption was considered to be 100%. Therefore, a factor of 10 was included for oral to dermal extrapolation, as a worst case approach.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default AF for rabbits according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 3
- Justification:
- AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.7 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEC
- Value:
- 18.2 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an inhalatory NOAEC observed in a subacute inhalation study (OECD 412, 1998). The NOAEC is corrected to account for differences between experimental conditions (6 h/day) and general population exposure conditions (24 h/day), as well as differences in experimental exposure frequency (5 days/week) and general population exposure frequency (7 days/week).
NOAECcorr = NOAEC*(6/24)*(5/7)
NOAECcorr = 18.2 mg/m³ * 0.25 * 0.71 = 3.25 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEC.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute inhalation study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 111 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a prenatal developmental toxicity study in rabbits (key, 1996). To convert the rabbit oral NOAEL into a corrected dermal NOAEL to assess human dermal exposure, the NOAEL has to be corrected as follows:
NOAELdermal = NOAELoral * (ABSoral-rabbit/ABSderm-human)
NOAELdermal = 2 mg/kg bw/day * (100/10) = 20 mg/kg bw/day
ABS = absorption.
Dermal absorption is considered to be 1% when handling concentrated test substance or 10% when diluted (Thiacloprid 2004: Sanco/4347/2000). Oral absorption was considered to be 100%. Therefore, a factor of 10 was included for oral to dermal extrapolation, as a worst case approach.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default AF for rabbits according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 3
- Justification:
- AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.1 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the starting point needed.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered..
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default AF for rabbits according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 3
- Justification:
- AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.