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EC number: 616-248-3 | CAS number: 75627-31-5
- 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:
- 97.8 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 760 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- ECHA guidance recommends that a factor of 2 be applied when doing route to route extrapolation for oral to inhalation exposure, recognizing higher absorption via the lungs. This additional assessment factor is not considered relevant in this particular case, since the substance is handled in a solution under industrial conditions and inhalation is therefore unlikely. Allometric scaling is applied by taking account for the different breathing rates between rats and humans, as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOAEC for workers.
- AF for dose response relationship:
- 1
- Justification:
- According to the ECHA guidance document Chapter R8, the default assessment factor is 1 when the starting point for the DNEL calculation is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor going from subacute to chronic, according to ECHA guidance document Chapter R8, in Table R. 8-5 Assessment factors for duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No additional factor as already included in the route to route extrapolation from the rat oral NOAEL to the equivalent human inhalation NOAEC.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive scientific review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for workers is 3 and not 5 as ECHA proposed, see discussion for detailed justification.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA guidance document Chapter R8, the default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1. Data used is based on testing of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) in a Klimisch 1 validity 28-day oral toxicity study performed according to GLP. Based on the quality of the available data and the low toxicity of the substance an assessment factor of 1 is considered justified.
- AF for remaining uncertainties:
- 1
- Justification:
- Possible uncertainties are already included in the assessment factors above, so a factor of 1 is applied.
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:
- 13.9 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- ECHA guidance assumes that absorption for dermal exposure is the same as for oral exposure, which is a worst case assumption.
- AF for dose response relationship:
- 1
- Justification:
- According to the ECHA guidance document Chapter R8, the default assessment factor is 1 when the starting point for the DNEL calculation is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor going from subacute to chronic, according to ECHA guidance document Chapter R8, in Table R. 8-5 Assessment factors for duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling between rat to human, according to ECHA guidance document Chapter R8, Table R. 8-3 Allometric scaling factors for different species as compared to humans.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive scientific review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for workers is 3 and not 5 as ECHA proposed, see discussion for detailed justification.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA guidance document Chapter R8, the default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1. Data used is based on testing of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) in a Klimisch 1 validity 28-day oral toxicity study performed according to GLP. Based on the quality of the available data an assessment factor of 1 is considered justified.
- AF for remaining uncertainties:
- 1
- Justification:
- Possible uncertainties are already included in the assessment factors above, so a factor of 1 is applied.
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)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Selection of Assessment factors for Intra – Inter species variation for workers and the general population (consumers)
ECHA (2010) has produced guidance on the assessment factors to use to derive a DNEL for human exposure based on the application of assessment factors (safety factors) to an NOAEL or LOAEL in animal studies.
The ECHA guidance proposes an assessment factor of 4 for the allometric scaling from rats to humans when calculating oral and dermal DNELs. However it then proposes an additional factor of 2.5 to cover remaining differences (uncertainties). There is no clear scientific justification for this additional factor. ECETOC in itsGuidance on Assessment Factors to Derive a DNEL (2010) reviewed the scientific evidence and concluded that the factor of 4 for rats was sufficient to cover the allometric scaling from rats to humans and any remaining differences are of intra-species rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter-species variability will not be used.
This ECETOC guidance also reviewed the intra-species assessment factors, which ECHA proposed as 5 for workers and 10 for the general population. ECETOC originally proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intra-species variability, which includes the remaining differences factor of 2.5. This was also confirmed in the ECETOC (2010) guidance.
After reviewing these guidance documents, we have adopted the proposal from ECETOC as our default assessment factors, but consider possible additional factors on a case by case basis.
In this case we have decided to use an assessment factor of 3 for workers based on the ECETOC Guidance (ECETOC, 2010). For consumers we have taken the ECETOC recommended factor of 5.
References:
ECHA, 2010 Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2 December 2010
ECETOC, 2010Guidance on Assessment Factors to Derive a DNEL,Technical Report No.110,ISSN-0773-8072-110 (print),ISSN-2079-1562-110 (online), October 2010
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 mg/m³
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Justification for route to route extrapolation: ECHA guidance recommends that a factor of 2 be applied when doing route to route extrapolation for oral to inhalation exposure, recognizing higher absorption via the lungs. This additional assessment factor is not considered relevant in this particular case, since the substance is handled in a solution under industrial conditions and inhalation is therefore unlikely. Allometric scaling is applied by taking account for the different breathing rates between rats and humans as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 mg/m3 inhalation NOAEC for consumers.
- AF for dose response relationship:
- 1
- Justification:
- According to the ECHA guidance document Chapter R8, the default assessment factor is 1 when the starting point for the DNEL calculation is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor going from subacute to chronic, according to ECHA guidance document Chapter R8, in Table R. 8-5 Assessment factors for duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No additional factor as already included in the route to route extrapolation from the rat oral NOAEL to the equivalent human inhalation NOAEC.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive scientific review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for general public is 5 and not 10 as ECHA proposed, see discussion for detailed justification.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA guidance document Chapter R8, the default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1. Data used is based on testing of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) in a Klimisch 1 validity 28-day oral toxicity study performed according to GLP. Based on the quality of the available data and the low toxicity of the substance an assessment factor of 1 is considered justified.
- AF for remaining uncertainties:
- 1
- Justification:
- Possible uncertainties are already included in the assessment factors above, so a factor of 1 is applied.
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:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- ECHA guidance assumes that absorption for dermal exposure is the same as for oral exposure, which is a worst case assumption.
- AF for dose response relationship:
- 1
- Justification:
- According to the ECHA guidance document Chapter R8, the default assessment factor is 1 when the starting point for the DNEL calculation is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor going from subacute to chronic, according to ECHA guidance document Chapter R8, in Table R. 8-5 Assessment factors for duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling between rat to human, according to ECHA guidance document Chapter R8, Table R. 8-3 Allometric scaling factors for different species as compared to humans.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive scientific review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for general public is 5 and not 10 as ECHA proposed, see discussion for detailed justification.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA guidance document Chapter R8, the default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1. Data used is based on testing of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) in a Klimisch 1 validity 28-day oral toxicity study performed according to GLP. Based on the quality of the available data and the low toxicity of the substance an assessment factor of 1 is considered justified.
- AF for remaining uncertainties:
- 1
- Justification:
- Possible uncertainties are already included in the assessment factors above, so a factor of 1 is applied.
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:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The DNEL is derived from a NOAEL in a 28 day oral study, so there no route to route extrapolation is needed.
- AF for dose response relationship:
- 1
- Justification:
- According to the ECHA guidance document Chapter R8, the default assessment factor is 1 when the starting point for the DNEL calculation is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor going from subacute to chronic, according to ECHA guidance document Chapter R8, in Table R. 8-5 Assessment factors for duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling between rat to human, according to ECHA guidance document Chapter R8, Table R. 8-3 Allometric scaling factors for different species as compared to humans.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive scientific review (see discussion) that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for general public is 5 and not 10 as ECHA proposed, see discussion for detailed justification.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA guidance document Chapter R8, the default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1. Data used is based on testing of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) in a Klimisch 1 validity 28-day oral toxicity study performed according to GLP. Based on the quality of the available data and the low toxicity of the substance an assessment factor of 1 is considered justified.
- AF for remaining uncertainties:
- 1
- Justification:
- Possible uncertainties are already included in the assessment factors above, so a factor of 1 is applied.
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
There is no exposureof the general population to nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5)based on the uses indicated in this dossier, since they are limited to industrial manufacture and formulation. However, to allow for evaluation from indirect exposures via the environment, DNELs have been derived for systemic toxicity from long term exposures via all routes.
Selection of Assessment factors for Intra – Inter species variation for workers and the general population (consumers)
ECHA (2010) has produced guidance on the assessment factors to use to derive a DNEL for human exposure based the application of assessment factors (safety factors) to an NOAEL or LOAEL in animal studies.
The ECHA guidance proposes an assessment factor of 4 for the allometric scaling from rats to humans when calculating oral and dermal DNELs. However it then proposes an additional factor of 2.5 to cover remaining differences (uncertainties). There is no clear scientific justification for this additional factor. ECETOC in its Guidance on Assessment Factors to Derive a DNEL (2010) reviewed the scientific evidence and concluded that the factor of 4 for rats was sufficient to cover the allometric scaling from rats to humans and any remaining differences are of intra-species rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter-species variability will not be used.
This ECETOC guidance also reviewed the intra-species assessment factors, which ECHA proposed as 5 for workers and 10 for the general population. ECETOC originally proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intra-species variability, which includes the remaining differences factor of 2.5. This was also confirmed in the ECETOC (2010) guidance.
After reviewing these proposals, we have adopted the proposal from ECETOC as our default assessment factors, but consider possible additional factors on a case by case basis.
In this case we have decided to use an assessment factor of 3 for workers based on the ECETOC Guidance (ECETOC, 2010). For consumers we have taken the ECETOC recommended factor of 5.
References:
ECHA, 2010Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2 December 2010
ECETOC, 2010Guidance on Assessment Factors to Derive a DNEL,Technical Report No.110,ISSN-0773-8072-110 (print),ISSN-2079-1562-110 (online), October 2010
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