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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-057-1 | CAS number: 102-81-8
- 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:
- 2.22 mg/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:
- 236.3 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 166.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modified starting point: 236.3 mg/m3 *6h/8h *7d/5d *6.7m3/10m3 = 166.2 mg/m3 (ECHA GD Chapter R.8: Characterisation of dose [concentration]-response for human health, section R.8.4.2; v2.1, Nov 2012)
- AF for dose response relationship:
- 1
- Justification:
- default for OECD TG study with 3 doses (ECHA GD R.8.4.3.1)
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute to chronic (ECHA GD R.8.4.3.1)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no allometric scaling, if expressed in concentration (e.g. mg/m3 in air) and/or already scaled according to the allometric principle (ECHA GD R.8.4.3.1)
- AF for other interspecies differences:
- 2.5
- Justification:
- default (ECHA GD 8.4.3.1)
- AF for intraspecies differences:
- 5
- Justification:
- default (ECHA GD 8.4.3.1)
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient and reliable studies (ECHA GD R.8.4.3.1)
- AF for remaining uncertainties:
- 1
- Justification:
- default (ECHA GD 8.4.3.1)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 9
- Dose descriptor:
- other: modified dose descriptor, taking into account no/light work but no time scaling: 20.6 mg/m3 *6.7 m3/10 m3 (ECHA GD R.8.4.2)
- Value:
- 13.8 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default for OECD TG study with 3 doses (ECHA GD R.8.4.3.1)
- AF for differences in duration of exposure:
- 3
- Justification:
- In line with ECHA GD R.8.4.3.1, the default factor of 6 for subacute to chronic extrapolation is not considered justified, because an impact of the exposure duration on the observed local effects is considered to be minor. Neither higher incidences nor more severity of the effects in the nasal cavity were observed in the high dose animals of the 90d study compared to the 14d DRF study. Furthermore, only one mid dose female of 90d study showed minimal effects in the nasal cavity, which were not observed in the 14d DRF study. However, an impact cannot fully be excluded and thus, a factor of 3 is used.
- AF for interspecies differences (allometric scaling):
- 3
- Justification:
- Concerning local effects allometric scaling is not necessary. However, Brüning et al., 2014 suggested an interspecies extrapolating factor (iEF) of 3 for extrapolating from animal data concerning local sensory irriating effects without reliable human data, unless individual data argue for a substance-specific approach. [Sensory irritation as a basis for setting occupational exposure limits, Arch Toxicol (2014) 88: 1855-1879].
- AF for other interspecies differences:
- 1
- Justification:
- An additional assessment factor for other interspecies differences is no considered necessary due to the iEF = 3, suggested by Brüning et al., 2014.
- AF for intraspecies differences:
- 1
- Justification:
- An additional assessment factor for intraspecies differences of workers is no considered necessary, due to the iEF = 3, suggested by Brüning et al., 2014; taking into account controlled human volunteer studies and epidemiological studies conducted in the worker environment.
Besides, according to the ECHA GD R.8 (v2.1, Nov 2012; section R.8.4.2) and the ECETOC TR110 [Guidance on assessment factors to derive a DNEL", Technical Report No. 110, ECETOC, 2010.] an extrapolation from animal data to exposure of workers results in the same overall inter-/intraspecies factor of 3:
- interspecies AF = 1, due to no allometric scaling for local effects, and if expressed in concentration and/or already scaled (ECHA GD R.8.4.3.1, ECETOC TR110);
- other interspecies AF = 1, according to ECETOC TR110 the other interspecies and intraspecies differences are interdependent and therefore this aspect is already taken into account in the intraspecies factor of 3 (ECETOC TR110);
- intraspecies AF = 3, the same factor for local effects is proposed in the ECETOC TR110 as for systemic effects, based on a detailed literature review. - AF for the quality of the whole database:
- 1
- Justification:
- sufficient and reliable studies (ECHA GD R.8.4.3.1)
- AF for remaining uncertainties:
- 1
- Justification:
- default (ECHA GD R.8.4.3.1)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
modified starting point: 1* oral NOAEL (ECHA GD R.8.4.2)
- AF for dose response relationship:
- 1
- Justification:
- default for OECD TG study with 3 doses (ECHA GD R.8.4.3.1)
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic to chronic (ECHA GD R.8.4.3.1)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat to human (ECHA GD 8.4.3.1)
- AF for other interspecies differences:
- 2.5
- Justification:
- default (ECHA GD 8.4.3.1)
- AF for intraspecies differences:
- 5
- Justification:
- default (ECHA GD 8.4.3.1)
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient and reliable studies (ECHA GD R.8.4.3.1)
- AF for remaining uncertainties:
- 1
- Justification:
- default (ECHA GD R.8.4.3.1)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Point of departure
- for inhalation long-term exposure – systemic effects:
The systemic NOAEC from a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in rats via inhalation conducted according to OECD 422 (BASF SE, 2013) was identified as the appropriate starting point for a systemic DNEL derivation for long-term exposure following inhalation. The NOAEC for general, systemic toxicity of the test substance was 236.3 mg/m³/day for rats which was the highest dose tested. The reduced FC, BW and BWG were considered to be secondary to the local irritating effects and thus, not taken into account for the systemic DNEL, as a local DNEL was also derived.
- for inhalation long-term exposure – local effects:
The local NOAEC from a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test in rats via inhalation conducted according to OECD 422 (BASF SE, 2013) was identified as the appropriate starting point for local DNEL derivation for long-term exposure following inhalation. The NOAEC for local irritation of respiratory tract was 20.6 mg/m³/day for rats.
- for dermal long-term exposure – systemic effects
The NOAEL from an 90d Study in rats with gavage administration in corn oil according to OECD 408 (BASF SE, 2019) was identified as the appropriate starting point for systemic DNEL derivation for long-term dermal exposure. The oral NOAEL in rats was 50 mg/kg bw/d, based on adverse effects observed in the kidney at 150 mg/kg bw/d.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are reliable experimental data on oral repeated exposure. No route to route extrapolation is needed.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for time extrapolation from subchronic to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value concerning allometric scaling rat - human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- The default value for "consumer" is used
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and reliable (GLP Guideline study)
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
For an assessment man via environment, an oral, systemic, long-term DNEL for the general population might be neccessary. However, as no consumer uses are known, no further DNELs for the general population were derived.
Oral long-term exposure – systemic effects:
The systemic NOAEL from a 90 day GLP repeated dose toxicity study in rats via oral administration conducted according to OECD 408 (BASF SE, 2019) was identified as the appropriate starting point for a systemic DNEL derivation for long-term exposure following oral administration. The NOAEL for general, systemic toxicity of the test substance was 50 mg/kg bw/day for rats. The assessment factors were applied according to the "Guidance on information requirements and chemical safety assessment, Chapter R.8, v 2.1, Nov. 2012.
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.