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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: 826-122-1 | CAS number: 13431-57-7
- 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://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:
- 8.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidace and ECETOC TR No.86 (2003)
- Overall assessment factor (AF):
- 45
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 370 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the inhalation route available. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the oral NOAEL of 300 mg/kg bw/day, obtained in the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) in Wistar rats [BASF, 2019]. The NOAECcorr. is calculated as follows:
- standard respiratory volume rat = 0.38 m³/kg/8h
- standard respiratory volume human = 6.7 m³/8h
- worker respiratory volume = 10 m³/8h
- absorption (oral, rat) = 50 % (default)
- absorption (inhalative, human) = 100 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected inhalatory NOAEC) = 300 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (50%/100%) * (7 exposure days/week; rat/5 exposure days/week; worker) = 370 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance: The recommended AF for the extrapolation from sub-acute to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance: no additional factor needed for extrapolation from oral to inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: The recommended default AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR No.86 (2003): In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor. The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidace and ECETOC TR No.86 (2003)
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 420 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the dermal route available. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the oral NOAEL of 300 mg/kg bw/day, obtained in the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) in Wistar rats [BASF, 2019]. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 50 % (default)
- absorption (dermal, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 300 mg/kg bw/day * (50%/50%) * (7 exposure days/week; rat/5 exposure days/week; worker) = 420 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance: The recommended AF for the extrapolation from sub-acute to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance: The default allometric scaling factor for the differences between rats and humans is applied.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: The recommended default AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR No.86 (2003): In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor. The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
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:
- 1.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidace and ECETOC TR No.86 (2003)
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the inhalation route available. Therefore, the general population-DNEL long-term for inhalation route - systemic is derived from the oral NOAEL of 300 mg/kg bw/day, obtained in the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) in Wistar rats [BASF, 2019]. The NOAECcorr. is calculated as follows:
- standard respiratory volume rat = 1.15 m³/kg/24h
- absorption (oral, rat) = 50 % (default)
- absorption (inhalative, human) = 100 % (default).As worst case, inhalative absorption is assumed to be two times more than oral absorption which allows for a modification of the starting point by factor 2.
- experimental exposure time = 7 days/week
- exposure time general population = 7 days/week
--> modified dose descriptor (corrected inhalatory NOAEC) = 300 mg/kg bw/day * (1/1.15 m³/kg/d) * (50%/100%) * (7 exposure days/week; rat / 7 exposure days/week; general population) = 130 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance: The recommended AF for the extrapolation from sub-acute to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance: no additional factor needed for extrapolation from oral to inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: The recommended default AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC TR No.86 (2003): In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor. The approach used for DNEL derivation is conservative. No further assessment factors are required.
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 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidace and ECETOC TR No.86 (2003)
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the dermal route available. Therefore, the general population-DNEL long-term for dermal route - systemic is derived from the oral NOAEL of 300 mg/kg bw/day, obtained in the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) in Wistar rats [BASF, 2019].
Modification of the dose descriptor starting point was not required, as no differences in the absorption rate and exposure between experimental animals and humans are expected:
- absorption (oral, rat) = 50 % (default)
- absorption (dermal, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time general population = 7 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 300 mg/kg bw/day * (50%/50%) * (7 exposure days/week; rat / 7 exposure days/week; general population) = 300 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance: The recommended AF for the extrapolation from sub-acute to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance: The default allometric scaling factor for the differences between rats and humans is applied.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: The recommended default AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC TR No.86 (2003): In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor. The approach used for DNEL derivation is conservative. No further assessment factors are required.
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 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidace and ECETOC TR No.86 (2003)
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The general population-DNEL long-term for the oral route - systemic is derived from the oral NOAEL of 300 mg/kg bw/day, obtained in the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) in Wistar rats [BASF, 2019].
Modification of the dose descriptor starting point was not required, as no differences in the absorption rate and exposure between experimental animals and humans are expected:
- absorption (oral, rat) = 50 % (default)
- absorption (oral, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time general population = 7 days/week
--> modified dose descriptor (corrected oral NOAEL) = 300 mg/kg bw/day * (50%/50%) * (7 exposure days/week; rat / 7 exposure days/week; general population) = 300 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance: The recommended AF for the extrapolation from sub-acute to chronic exposure is applied.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance: The default allometric scaling factor for the differences between rats and humans is applied.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: The recommended default AF for other interspecies differences is applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC TR No.86 (2003): In an attempt to evaluate the intraspecies variability within the human population, the distribution of human data for various toxicokinetic and toxicodynamic parameters were examined (Hattis et al 1987, 1999; Hattis and Silver 1994; Renwick and Lazarus, 1998; see ECETOC TR No.86, 2003). These evaluations included data from ‘healthy adults’ of both sexes, as well as limited data from the young and elderly, mixed races and patients with various medical conditions such as cancer and hypertension. The data of Renwick and Lazarus (1998) and Hattis et al (1999) were based exclusively on human data and similar values were obtained within each percentile. Considering that the data analysed by these authors included both sexes, a variety of disease states and ages, the use of the 95thpercentile is considered sufficiently conservative to account for intraspecies variability in the general population. Thus, a default assessment factor of 5 was taken for the general population with a lower factor of 3 (i.e. closer to the 90thpercentile) for the more homogenous worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor. The approach used for DNEL derivation is conservative. No further assessment factors are required.
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.
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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