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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 203-265-2 | CAS number: 105-05-5
- 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:
- 8.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance combined with ECETOC
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 158.68 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- In the absence of repeated dose inhalation toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (30 mg/kg bw/day) can be taken as a starting point for deriving a DNELlong-term, workers, inhalation. The value must first be corrected for route differences as described in REACH guidance document R.8 version 2.1, November 2012 (‘Characterisation of dose (concentration)-response for human health’) to obtain a corrected inhalation NOAEC: Inhalation NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) x ABSoral/ABSinh = (30 / 0.38) x (6.7/10) x (90/30) = 158.6842 mg/m3 Based on the toxicokinetics assessment ABSoral=90% and ABSinhalation=30%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- base-study 28 days (subacute)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC (not considered)
- AF for intraspecies differences:
- 3
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
- In the absence of repeated dose inhalation toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (30 mg/kg bw/day) can be taken as a starting point for deriving a DNELlong-term, workers, inhalation. The value must first be corrected for route differences as described in REACH guidance document R.8 version 2.1, November 2012 (‘Characterisation of dose (concentration)-response for human health’) to obtain a corrected inhalation NOAEC: Inhalation NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) x ABSoral/ABSinh = (30 / 0.38) x (6.7/10) x (90/30) = 158.6842 mg/m3 Based on the toxicokinetics assessment ABSoral=90% and ABSinhalation=30%.
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA guidance combined with ECETOC
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 270 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- In the absence of repeated dose dermal toxicity data, the NOAEL from the 28 day repeated dose oral toxicity study in rat (30 mg/kg bw/day) can be taken as a starting point for deriving a DNELlong-term, workers, dermal. In a first step, the oral value should be corrected for route-to-route extrapolation. In accordance with REACH Guidance document R8 (v2.1, November 2012) the dermal NOAEL is calculated according to: Dermal N(L)OAEL=oral (N(L)OAEL x ( ABSoral/ABSdermal). Based on the toxicokinetics assessment ABSoral=90% and ABSdermal=10%. The Dermal Corrected NOAEL=270 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- base-study 28 days (subacute)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC (not considered)
- AF for intraspecies differences:
- 3
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low 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
The derivation of DNELS for workers has taken into consideration how the substance is used and the toxicological properties available for the substance.
The substance is used as such. The substance is manufactured in closed system and connected to exhaustion systems. The registrant doesn't manufacture the substance in EU. The substance is used in EU in industrial sites as auxiliary and/or as an intermediate. Exhaustion systems are also considered to be in place not allowing the substance to reach workers.
No non-threshold effects for this substance were identified.
The substance causes local effects: skin and eye irritation.
The substance doesn't cause acute toxic effects.
The starting point for DNEL calculations is the NOAEL (oral route - rat) from a <90-day study = 30 mg/kg bw/day. Following the Practical Guide 14 and the ECHA Guidance R.8, the NOAEL oral is corrected to a NOAEC, which is used afterwards to derive the DNELs.
The Assessment Factors taken are the ones as described in ECETOC Technical Reports No 86 and 110.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.61 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance combined with ECETOC
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 78.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral * (1 / 1.15 m3/kg/d) * (ABSoral-rat/ABSinh-human) NOAECcorr = 30 * (1/1.15) * (90/30) = 78.26 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- base study duration <90 days
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC (not considered)
- AF for intraspecies differences:
- 5
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.61 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral * (1 / 1.15 m3/kg/d) * (ABSoral-rat/ABSinh-human) NOAECcorr = 30 * (1/1.15) * (90/30) = 78.26 mg/m3
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance combined with ECETOC
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 270 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- It is considered that the oral and dermal absorption rates are 90% and 10% respectively, and the following equation has been applied: NOAECcorr = NOAELoral * (ABSoral-rat/ABSdermal-human), NOAECcorr = 30 * (0.9/0.1) = 270 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- base study <90 days
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC (not considered)
- AF for intraspecies differences:
- 5
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.25 mg/kg bw/day
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- other: ECHA REACH Guidance combined with ECETOC
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is not route-to-route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- study base <90 days
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC (not considered)
- AF for intraspecies differences:
- 5
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The derivation of DNELS for general population has taken into consideration how the substance reaches the targets.
The substance is only used in an industrial site. In case of an accidental release it is possible that the substance gets out of the site.
No non-threshold effects for this substance were identified.
The substance causes local effects: skin and eye irritation.
The substance doesn't cause acute toxic effects.
The starting point for DNEL calculations is the NOAEL (oral route - rat) from a <90-day study = 30 mg/kg bw/day. Following the Practical Guide 14 and the ECHA Guidance R.8, the NOAEL oral is corrected to a NOAEC.
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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