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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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: - | CAS number: -
- 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:
- 7.05 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point: NOAEL from OECD 407 study via oral gavage
Modified dose descriptor starting point: NOAEC (Most sensitive endpoint used)
Inhalation NOAEC = oral NOAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)
(ABSoral/ABSinh.) = 0.5
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- The relevant dose descriptors considered for DNEL derivation is a NOAEL value from a gavage repeated dose toxicity study (OECD TG 407, reliability 1).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute toxicity hazard (leading to C&L) has been identified for the target substance following oral and dermal exposure. Therefore, according to ECHA R8 Guidance, no DNEL (acute) should be set.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELhuman-dermal
= NOAELrat -oral*(ABSrat-oral÷ABShuman-dermal)
= 600 mg/kg/d *ratio
Absorptionrat-oral= 2*Absorptionhuman-dermal
Justifications for low dermal absorption were included in CSR
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No hazard identified
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Dose descriptor starting point:NOAEL from OECD 407 study via oral gavage
Modified dose descriptor starting point:NOAEC (Most sensitive endpoint used)
Inhalation NOAEC = oral NOAEL/1.15m3/kg/d*(ABSoral/ABSinh.)
(ABSoral/ABSinh.) = 0.5
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute toxicity hazard (leading to C&L) has been identified for the target substance following oral and dermal exposure. Therefore, according to ECHA R8 Guidance, no DNEL (acute) should be set.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELhuman-dermal
= NOAELrat -oral*(ABSrat-oral÷ABShuman-dermal)
Absorptionrat-oral= 2*Absorptionhuman-dermal
Justifications for dermal absorption were included in CSR
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No hazard identified
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The relevant dose descriptors considered for DNEL derivation is a NOAEL value from a gavage 28-day repeated dose toxicity study (OECD TG 407, reliability 1).In this study the highest dose level of 600 mg/kg bw/day resulted in premature deaths of three females. These deaths were considered to be related to the irritant properties of the test item and gavage-related reflux rather than an indication of its systemic toxicity. The NOAEL is therefore 600 mg/kg bw/day in rats.
- AF for dose response relationship:
- 1
- Justification:
- Key study used a dose range that demonstrated a clear dose-response relationship
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No hazard identified
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.