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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 938-999-9 | 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
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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:
- 23.5 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):
- 37.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation repeated toxicity study has been performed, because toxicological literature regarding alkyl polyglucosides is very exhaustive and no additional animal testing was deemed necessary.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 3
- Justification:
- An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling does not apply in case of oral-inhalation route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotssium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertaintens are foreseen.
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
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:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation was necessary, because a 14-day repeated toxicity study was available for the dermal route of exposure.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Data derive from a subacute toxicity study.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Allometric scaling for rabbits involves a default assessment factor of 2.4.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps. Moreover, the original study, although not available, is reported by a reliable source (Hill at al., 1997).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertaintens are foreseen.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 59 µg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor:
- other: LOAEL: 60 mg/kg bw/day
- AF for dose response relationship:
- 4
- Justification:
- The use of a LOAEL instead of a NOAEL involves the use of a default assessment factor between 3 and 10. In this case, the study does not report information on dose-response relationship.
- AF for differences in duration of exposure:
- 1
- Justification:
- It has been considered that increasing the duration of exposure does not increase the severity of the irritative effects.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
- AF for other interspecies differences:
- 1
- Justification:
- No inter-species AF has been applied, because the mechanism of skin irritation is considered to be the same in experimental animals and in human.
- AF for intraspecies differences:
- 5
- Justification:
- An assessment factor of 5 has been chosen to cover workers, as this population does not cover the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps. Moreover, the original study, although not available, is reported by a reliable source (CIR, 2011).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertaintens are foreseen.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Two DNEL values were derived for systemic effects after long-term exposure in workers: a dermal DNEL and an inhalation DNEL. Values were obtained from the NOAELs of an oral repeated toxicity study and of a NOAEL of a dermal 14-day repeated toxicity study. As this NOAELs were observed in an oral and a dermal study, respectively, a route-to-route extrapolation was needed in order to obtain the correct starting point for the derivation of the inhalation DNEL. Moreover, a DNEL for dermal local effects after repeated exposure was derived. In this case the dermal NAEL for local effects needed to be corrected into the correct unit. The correct starting points were then divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered. No DNEL was derived for local inhalation effects after long term exposure, for which a qualitative assessment has been performed.
For acute effects, no DNEL was deemed necessary, because no acute toxicity hazards (leading to C&L) have been identified, with the only exception of the risk of serious eye damage, which was considered from a qualitative point of view. Peak exposure to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite"is not expected, and therefore the long-term DNELs are considered conservative enough to protect also from acute exposure risks.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation repeated toxicity study has been performed, because toxicological literature regarding alkyl polyglucosides is very exhaustive and no additional animal testing was deemed necessary.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 3
- Justification:
- An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling does not apply in case of oral-inhalation route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- An assessment factor of 10 has been chosen to cover general population, as this population includes also the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertaintens are foreseen.
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
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
- Route of original study:
- Dermal
Acute/short term exposure
- Route of original study:
- Dermal
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation was necessary as the route of the starting study was oral.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation was a NOAEL, therfore the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 3
- Justification:
- An assessment factor of 3 has been applied in order to consider the differences the duration of the exposure in the oral 90-day repeated toxicity study and the
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling for rats involves a default assessment factor of 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available, so a default assessment factor of 2.5 has been applied for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- An assessment factor of 10 has been chosen to cover general population, as this population includes also the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Data regarding "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" are complete and of good quality, indeed, where no specific studies regarding the substance are available, literature regarding alkyl polyglucosides covers all the data gaps.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertaintens are foreseen.
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:
- low hazard (no threshold derived)
Additional information - General Population
Two DNELs were derived for systemic effects after long-term exposure in workers: an inhalation DNEL for systemic effects and a DNEL for oral effects. Values were obtained from the NOAEL of an oral repeated toxicity study, therefore a route-to-route extrapolation was needed in order to obtain the correct starting point for the derivation of the DNEL.
The correct starting points were divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered. No DNEL was derived for local inhalation effects after long term exposure, for which a qualitative assessment has been performed.
For acute effects, no DNEAL was deemed necessary, because no acute toxicity hazards (leading to C&L) have been identified, with the only exception of the risk of serious eye demage, which was considered from a qualitative point of view. Peak exposure to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" is not expected, and therefore the long-term DNEL are considered conservative enough to protect also from acute exposure risks.
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.
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