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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-681-1 | CAS number: 98-56-6
- 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
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:
- 0.029 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25 000
- Dose descriptor starting point:
- T25
- Modified dose descriptor starting point:
- other: corrected T25
- Value:
- 741.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A two year carcinogenicity study via inhalation route on rats and mice was selected as most sensitive end-point.
For non-threshold carcinogencity studies, the dose descriptor to be calculated is the T25.
T25 values were calculated for both benign and malignant tumours at the lowest tumorogenic response, according to ECHA guidance R.8 and Dybing E. et all (1997)1
The lowest T25 calculated for inhalation exposure was 738.45 mg/m3 obtained from the % of incidence of neoplastic lesions on thyroid gland of female rats.
The corrected T25 and the DMEL for inhalation workers were calculated using a default sequence of extrapolation and a “linearised” approach:
T25corrected = 738.45 mg/m3 x 6.7/10 x 1.5 * = 741.7 mg/m3
DMEL (based on T25) = T25corrected/factor for high to low dose extrapolation = 741.7 mg/m3 / 25.000 = 0.029 mg/m3
* this factor is calculated considering the hours of exposure during inhalation study (6), the hours of exposure of workers (8), the day per week of exposure (5 in the study for rats and 5 per workers), the week of workers exposure per years (48 vs 52) and the years in the lifetime (40 vs 75), following the formula: 6/8 x 5/5 x 52/48 x 75/40
- Dybing E, Sanner, Roelfzema H., Kroese D. and Tennant R.; “Simplified Carcinogenic Potency Index: Description of the System and Study of Correlations between Carcinogenic Potency and Specied Site Specificity and Mutagenicity”, Pharmacology & Toxicology 1997, 80, 272-279.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
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
- Most sensitive endpoint:
- carcinogenicity
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:
- 0.017 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25 000
- Dose descriptor starting point:
- T25
- Modified dose descriptor starting point:
- other: corrected T25
- Value:
- 417.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A two year carcinogenicity study via inhalation route on rats and mice was selected as most sensitive end-point.
For non-threshold carcinogencity studies, the dose descriptor to be calculated is the T25.
T25 values were calculated for all benignant and malignant tumours at the lowest tumorogenic response, according to ECHA guidance R.8 and Dybing E. et all (1997)1
The lowest T25 calculated was 738.5 mg/m3, obtained from data on the incidence % of neoplastic lesions on thyroid gland of female rats.
To correct this value in mg/kg bw the following formula is applied:
T25 (mg/kg bw) = (hours of exposure x inhalation volume for female rats x 738.5 mg/m3) x 1000 g / mean bw rats in g = (6h x 15.7 l/h x 0.001 x 738.5 mg/m3) x 1000 / 250 = 278.25 mg/kg bw
The corrected T25 for workers dermal, is calculated using a default sequence of extrapolation and a “linearised” approach:
T25corrected = 278.25 mg/kg bw x 1.5*= 417.4 mg/kg bw
DMEL (based on T25) = T25corrected/factor for high to low dose extrapolation = 417.4 mg/kg bw / 25.000 = 0.017 mg/kg/bw
* this factor is calculated considering the hours of exposure during inhalation study (6), the hours of exposure of workers (8), the day per week of exposure (5 in the study for rats and 5 per workers), the week of workers exposure per years (48 vs 52) and the years in the lifetime (40 vs 75), following the formula: 6/8 x 5/5 x 52/48 x 75/40
- Dybing E, Sanner, Roelfzema H., Kroese D. and Tennant R.; “Simplified Carcinogenic Potency Index: Description of the System and Study of Correlations between Carcinogenic Potency and Specied Site Specificity and Mutagenicity”, Pharmacology & Toxicology 1997, 80, 272-279.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- carcinogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.6 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 450
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- LOAEL as the starting dose
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the AF for other interspecies differences
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 3
- Justification:
- skin sensitization specific AF ( 3 for differences in vehicle, 1 for differences in exposure conditions)
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:
- 0.001 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100 000
- Dose descriptor starting point:
- T25
- Modified dose descriptor starting point:
- other: corrected T25
- Value:
- 131.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A two year carcinogenicity study via inhalation route on rats and mice was selected as most sensitive end-point.
For non-threshold carcinogencity studies, the dose descriptor to be calculated is the T25.
T25 values were calculated for both benign and malignant tumours at the lowest tumorogenic response, according to ECHA guidance R.8 and Dybing E. et all (1997)1
The lowest T25 calculated for inhalation exposure was 738.45 mg/m3 obtained from the % of incidence of neoplastic lesions on thyroid gland of female rats.
The corrected T25 and the DMEL for inhalation general population were calculated using a default sequence of extrapolation and a “linearised” approach:
T25corrected = 738.45 mg/m3 x 0.18 * = 131.9 mg/m3
DMEL (based on T25) = T25corrected/(interspecies extrapolation factor x factor for high to low dose extrapolation) = 131.9 mg/m3 /(4 x 25.000) = 0.0013 mg/m3
* this factor is calculated considering the hours of exposure during inhalation study (6), the hours of exposure for general population (24), the day per week of exposure (5 in the study for rats and 7 for general population): 6/24 x 5/7
- Dybing E, Sanner, Roelfzema H., Kroese D. and Tennant R.; “Simplified Carcinogenic Potency Index: Description of the System and Study of Correlations between Carcinogenic Potency and Specied Site Specificity and Mutagenicity”, Pharmacology & Toxicology 1997, 80, 272-279.
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From rat to human
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- carcinogenicity
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:
- 0.001 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100 000
- Dose descriptor starting point:
- T25
- Modified dose descriptor starting point:
- other: corrected T25
- Value:
- 50.1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A two year carcinogenicity study via inhalation route on rats and mice was selected as most sensitive end-point.
For non-threshold carcinogencity studies, the dose descriptor to be calculated is the T25.
T25 values were calculated for both benign and malignant tumours at the lowest tumorogenic response, according to ECHA guidance R.8 and Dybing E. et all (1997)1
The lowest T25 calculated for inhalation exposure was 738.45 mg/m3 obtained from the % of incidence of neoplastic lesions on thyroid gland of female rats.
To correct this value in mg/kg bw the following formula is applied:
T25 (mg/kg bw) = (hours of exposure x inhalation volume for female rats x 738.5 mg/m3) x 1000 g / mean bw rats in g = (6h x 15.7 l/h x 0.001 x 738.5 mg/m3) x 1000 / 250 = 278.24 mg/kg bw
The corrected T25 for general population dermal, is calculated using a default sequence of extrapolation and a “linearised” approach:
T25corrected = 278.24 mg/kg bw x 0.18*= 50.1 mg/kg bw
DMEL (based on T25) = T25corrected/(interspecies extrapolation factor x factor for high to low dose extrapolation) = 50.1 mg/kg bw /(4 x 25.000) = 0.0005 mg/kg bw
* this factor is calculated considering the hours of exposure during inhalation study (6), the hours of exposure for general population (24), the day per week of exposure (5 in the study for rats and 7 for general population): 6/24 x 5/7
- Dybing E, Sanner, Roelfzema H., Kroese D. and Tennant R.; “Simplified Carcinogenic Potency Index: Description of the System and Study of Correlations between Carcinogenic Potency and Specied Site Specificity and Mutagenicity”, Pharmacology & Toxicology 1997, 80, 272-279.
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- carcinogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 900
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- LOAEL as the starting dose
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the AF for other interspecies differences
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 3
- Justification:
- skin sensitization specific AF ( 3 for differences in vehicle, 1 for differences in exposure conditions)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.001 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100 000
- Dose descriptor starting point:
- T25
- Modified dose descriptor starting point:
- other: corrected T25
- Value:
- 50.1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A two year carcinogenicity study via inhalation route on rats and mice was selected as most sensitive end-point.
For non-threshold carcinogencity studies, the dose descriptor to be calculated is the T25.
T25 values were calculated for both benign and malignant tumours at the lowest tumorogenic response, according to ECHA guidance R.8 and Dybing E. et all (1997)1
The lowest T25 calculated for inhalation exposure was 738.45 mg/m3 obtained from the % of incidence of neoplastic lesions on thyroid gland of female rats.
To correct this value in mg/kg bw the following formula is applied:
T25 (mg/kg bw) = (hours of exposure x inhalation volume for female rats x 738.5 mg/m3) x 1000 g / mean bw rats in g = (6h x 15.7 l/h x 0.001 x 738.5 mg/m3) x 1000 / 250 = 278.24 mg/kg bw
The corrected T25 for general population dermal, is calculated using a default sequence of extrapolation and a “linearised” approach:
T25corrected = 278.24 mg/kg bw x 0.18*= 50.1 mg/kg bw
DMEL (based on T25) = T25corrected/(interspecies extrapolation factor x factor for high to low dose extrapolation) = 50.1 mg/kg bw /(4 x 25.000) = 0.0005 mg/kg bw
* this factor is calculated considering the hours of exposure during inhalation study (6), the hours of exposure for general population (24), the day per week of exposure (5 in the study for rats and 7 for general population): 6/24 x 5/7
- Dybing E, Sanner, Roelfzema H., Kroese D. and Tennant R.; “Simplified Carcinogenic Potency Index: Description of the System and Study of Correlations between Carcinogenic Potency and Specied Site Specificity and Mutagenicity”, Pharmacology & Toxicology 1997, 80, 272-279.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- 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.