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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-182-9 | CAS number: 1426148-68-6
- 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:
- 4.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance with substance specific modifications
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data for submission substance on repeated doese toxicity following inhalation exposure available
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (reliable dose-response, POD is NOAEL)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA Guidance (inhalation route)
- AF for other interspecies differences:
- 1
- Justification:
- Effects mainly driven by surfactant nature of substance, kinetic data suggests comparable metabolic pathways between rats and humans
- AF for intraspecies differences:
- 5
- Justification:
- combined AF for intraspecies and remaining uncertainty (toxicokinetic plus toxicodynamic aspect) based on German Committe on Hazardous Substances (AGS; BekGS 901 dated April 2010) and ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- Available data package comprehensive and plausible, read-across robust and scientifically valid
- AF for remaining uncertainties:
- 2
- Justification:
- ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
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:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA Guidance with substance specific modifications
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation performed. Data from subchronic dermal study.
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance (reliable dose-response, POD is NOAEL)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- Modified according to German Committee of Hazardous Substances (AGS) and ECETOC, no differences in toxicokinetics between species expected
- AF for intraspecies differences:
- 5
- Justification:
- Modified according to German Committee of Hazardous Substances (AGS) and ECETOC, combined inter-/intraspecies AF (toxicokinetic and toxicodynamic aspect)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data package comprehensive and plausible, read-across robust and scientifically valid
- AF for remaining uncertainties:
- 1
- Justification:
- No route-to-route extrapolation
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Workers - Hazard via inhalation route
No route-specific acute and/or repeated inhalation toxicity data is available for the submission substance. As default, route-to-route extrapolation is performed using the NOAEL of 50 mg/kg body weight per day from a 90 -day oral toxicity study, which was identified as key study for repeated dose toxicity. This NOAEL is used as starting point for the derivation of the worker DNEL "long-term inhalation exposure - systemic effects". Although the leading adverse effects are considered mainly driven by the surfactant nature of the substance without any histopathological correlate and/or functional disturbances and no species differences due to comparable toxicokinetics are expected, a conservative approach is taken and the default factor of 2 for remaining uncertainties using route-to-route extrapolation is applied.
The corrected inhalatory NOAEC is obtained according REACH Guidance R.8 as 88 mg/m3. With regard to interspecies differences, allometric scaling concerning oral-to-inhalation extrapolation is not appropriate and no assessment factor is applied (ECHA Guidance). The adjustment for remaining differences is not considered scientifically justified (ECETOC 2010). Analysis of various data sets have revealed that a separate factor for remaining interspecies differences need not always be established because these are being accounted for by the assessment of intraspecies variability. Based on scientific evidence, ECETOC is proposing overall assessment factors of 3 for workers, which includes the remaining interspecies differences. A factor of 1 for remaining interspecies differences is also supported, because toxicokinetics differed not between species. However, taking into account the overall toxicity profile of the submission substance and the read-across approach used, a somewhat more conservative approach is taken and a combined inter-/intraspecies assessment factor of 5 is considered. This is in line with a similar concept developed by the German Committee for Hazardous Substances (AGS 2010 [Technische Regeln für Gefahrstoffe. Begründungen und Erläuterungen zu Grenzwerten in der Luft am Arbeitsplatz. Ausschuss für Gefahrstoffe. BekGS 901, April 2010]) . Since the assessment is based on the outcome of a 90 -day repeated dose toxicity study, time extrapolation to chronic exposure conditions generally have to be considered and the default factor of 2 is used. Since the available data are considered adequate for labelling and classification purposes of the submission substance, the quality of the data base is judged sufficient for evaluation and thus, an assessment factor of 1 is applied. The resulting overall assessment factor is 20 (2 x 5 x 2) resulting in a DNEL "long-term inhalation exposure - systemic effects" of 4.4 mg/m3.
Workers - Hazard via dermal route
With regard to dermal exposure, a subchronic study revealed no significant adverse effects with regard to most parameters investigated, including clinical toxicity, clinical chemistry, haematology and urinalysis. No histopathological changes were detected in any organ investigated and no indications of functional organ changes were revealed. Organ weights were in general not influenced except a slight increase of kidney weights in high dose animals. Although no histopathological correlate was found, the NOAEL of this study was conservatively placed at 80 mg/kg body weight per day. The DNEL derivation for long-term systemic effects following dermal exposure as well as the selection of assessment factors for the extrapolations followed the same rational like for the inhalation route. No route-to-route extrapolation is necessary and thus AFs of 1 for dose-response and quality of data base are appropriate. Since the POD is a NOAEL coming from a subchronic (90-day) study, an assessment factor of 2 for time extrapolation is used according to ECHA guidance. Likewise, allometric scaling is performed using an AF of 4 (rat to human). As explained in more detail above, a combined AF of 5 is used to account for potential inter- / intraspecies differences, although from the toxicokinetic data no significant distinct metabolism is to be expected. The resulting overall assessment factor is 40 (2 x 4 x 5) resulting in a DNEL "long-term dermal exposure - systemic effects" of 2 mg/kg body weight per day.
Additional information
No DNELs are derived for acute systemic toxicity and for local effects following acute exposure. It is concluded that short-term exposures are well-controlled by conditions for long-term exposure. Additionally, proper technical and personal risk management measures are in place to protect against local effects and ensure safe use conditions.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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
No consumer use identified and/or supported.
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.