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EC number: 605-140-1 | CAS number: 158237-07-1
- 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
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:
- 0.145 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.52 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.814 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a sub-chronic toxicity study in dogs (OECD 452). To convert the dog oral NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure, the NOAEL has to be corrected as follows:
Corrected inhal NOAEC = NOAEL(oral) × (1 ÷ sRVdog) × (ABSoral-dog ÷ ABSinh-human) × (sRVhuman ÷ wRV) × (Fstudy ÷ Fworker)
= 0.52 mg/kg bw/day × (1 ÷ 0.134 m³/kg bw) × (1 ÷ 2) × (6.7 m³ ÷ 10 m³) × (7 ÷ 5) = 0.145 mg/m³
sRV = standard respiratory volume; wRV = respiratory volume light activity for worker (8 h); ABS = absorption; Fstudy = frequency of exposure in study; Fworker = frequency of exposure worker
Route-to-route extrapolation within the Beagle dog was based on the respiratory volume of 0.3 L/min/kg bw, leading to an inhalation volume of 0.134 m³/kg bw for a time period of 8 hours, reflecting the normal duration of an 8-hour work shift. The resulting air concentration has been corrected by a factor of 0.67 considering the ratio of the normal inhalation volume of 6.7 m³/person over 8 hours and the increased inhalation volume of 10 m³/person of workers during light activity at work. Moreover, the NOAEL was corrected for the differences in the experimental and human exposure conditions. The animals (dog) were exposed to the test substance 7 days/week, whereas workers are in general exposed 5 days/week (factor 7 days/5 days).
As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption.
Thus, the corrected starting point for workers is 0.145 mg/m³ for inhalation.
- 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 chronic study peformed in dogs over a time period of 1 year.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not applicable for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers 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:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- 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
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:
- 0.833 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on a dermal NOAEL observed in a repeated dose toxicity study in rats (OECD 410). The frequency of treatment in the dermal repeated dose toxicity study was 5 days/week for the first three weeks and 7 days/week thereafter for 6 h. As the animals were mainly exposed 5 days/week, the frequency of exposure is identical to the exposure frequnency of the worker and no correction factor for the frequency was applied. Therefore, no modification of the dose descriptor starting point is neccessary. An AF of 6 for the conversion of the subacute study to a chronic exposure, an AF of 10 (2.5 x 4) to correct for interspecies differences between rat and man, followed by a factor of 5 to cover for individual variations among the workers were applied.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default value 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:
- 1
- Justification:
- No remaining uncertainties.
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:
- skin irritation/corrosion
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:
- 0.024 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.52 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.605 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.43 m³/kg bw/day (24h)) *(ABSoral-rat/ABSinh-human) = 0.52 mg/kg bw/day*(1/0.43 m³/kg bw/day)*(1/2) = 0.605 mg/m³.
ABS(oral/rat) = oral absorption rate in rats, ABS(inh./human) = inhalation absorption rate in humans
Starting point for the DNEL derivation is the human NAEC for inhalation exposure over 24 hours of 0.605 mg/m³. This value is based on the conversion of the chronic oral NOAEL of 0.52 mg/kg bw/day for dogs from the 1-year study to the corresponding air concentration over a period of 24 hours. Route-to-route extrapolation within the Beagle dog was based on the respiratory volume of 0.3 L/min/kg bw, leading to an inhalation volume of 0.43 m³/kg bw for a time period of 24 hours, reflecting continuous exposure via the environment. As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption.
An assessment factor 10 was included to take care of possible intraspecies differences within the general population and an assessment factor of 2.5 for other interspecies differences was considered. However, the substance is not intended for use by the general population, therefore exposure is unlikely.
- 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 chronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default value 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:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not classified for acute inhalation toxicity according to Regulation (EC) No 1272/2008.
Short-term high exposures are considered unlikely given the levels of control in place at sites producing
and using the substance
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.298 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 178.57 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on a dermal NOAEL observed in a repeated dose toxicity study
in rats (OECD 410). As the frequency of treatment in this study was predominantly 5 days/week, and the exposure frequency of the general population is 7 days/week, the dose descriptor starting point is modified with the factor 5/7 to 178.57 mg/kg bw/day.
An AF of 6 for the conversion of the subacute study to a chronic exposure, an AF
of 10 (2.5 x 4) to correct for interspecies differences between rat and man, followed by a factor of 10 to
cover for individual variations among the workers were applied.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default value 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:
- 1
- Justification:
- No remaining uncertainties.
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:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.017 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):
- 35
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.52 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.52
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a chronic toxicity study in dogs (OECD 452).
As the frequency of treatment in the study (7 days/week) was identical to the exposure frequency of the general population no correction factor for the frequency was applied. Therefore, no modification of the dose descriptor starting point is necessary.
Further, there is no route-to-route extrapolation necessary.
Starting point for the DNEL derivation is the chronic oral NOAEL of 0.52 mg/kg bw/day from the 1-year study in dogs as most sensitive species. An assessment factor (AF) of 1.4 is included for correction of interspecies differences between dogs and humans, an AF of 2.5 for other interspecies differences and a factor of 10 to consider possible intraspecies differences within the general human population. However, the substance is not intended for use by the general population, therefore exposure is unlikely.
- 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 chronic study.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The experimental animal was the dog.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default value 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:
- 1
- Justification:
- No remaining uncertainties.
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
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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