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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.
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EC number: 258-469-4 | CAS number: 53306-54-0
- 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:
- 35.3 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There is one repeated dose inhalation study available (BASF, 2013). However, the duration of exposure of this study (5 days) is too short to serve as a reasonable starting point for a longterm DNEL derivation. There are no other relevant experimental data on repeated exposure by inhalation.
Hence, an oral study with dose descriptor modification was used as a starting point (see discussion for further information). A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from 2 generation study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Effects are secondary to altered/enhanced liver metabolism. No organ damage was observed. An additional factor for remaining toxicodynamic differences is not deemed necessary.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effects are related to the deposited concentration rather than the total dose (AUC). Therefore, no AF for exposure duration is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 125 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):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated dermal exposure. Taken into account the available toxicokinetic data, dermal absoption is anticipated to be 4 % and oral absoption is estimated to be 50%.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from 2 generation study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Effects are secondary to altered/enhanced liver metabolism. No organ damage was observed. An additional factor for remaining toxicodynamic differences is not deemed necessary.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance. In view of the data used for evaluation, the "quality of whole database factors" and the “factor for remaining uncertainties“ is considered to amount to a value of 1. Based on the available experimental data there is no evidence for interspecies differences in the general mode of action or kinetics. The observed effects are considered secondary to altered / enhanced liver metabolism, which is already covered by the factors for allometric scaling.
Acute/short-term exposure - systemic effects
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). As this substance is not classified, no acute systemic DNELs need to be calculated.
Acute/short-term and long-term exposure-local effects
Skin and eye irritation/corrosion and sensitization:
The skin and eye irritation and sensitization potential of the test item was assessed in several in vivo studies. The test item has been demonstrated to be neither irritating nor sensitising.
Respiratory irritation:
A short-term inhalation toxicity study (BASF SE, 2013) revealed that the test substance has irritating properties in the respiratory tract. Based on these findings a long-term inhalation DNEL for local effects is derived. The NOAEC of 50 mg/m³ is identified as the relevant dose descriptor and starting point.
Modification into a correct starting point:
Using a conservative approach, a worker DNEL (long-term inhalation exposure) is derived. This worker DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure.
Relevant dose descriptor (NOAEC): 50 mg/m³
Exposure duration rat: 6 h/d
Exposure duration worker: 8 h/d
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Corrected inhalatory NOAEC for workers
= 50 mg/m³ × (6 h/d/8 h/d) × (6.7 m³/10 m³)
= 25.1 mg/m³
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Intraspecies differences (worker): 5
Taking the above mentioned assessment factors into account, the following worker long term inhalation DNEL for local effects is:
25.1 mg/m³ / (1 x 1 x 1 x 5 ) = 25.1 mg/m³ / 5
= 5 mg/m³
Long-term exposure-systemic effects
In a 90-day oral repeated dose toxicity study (BASF, 1995) and an oral 2 generation study (BASF, 2009) in rats, similar NOAELs were identified. Both studies showed peroxisomal proliferation, altered liver metabolism and associated secondary changes in blood parameters, and reduced body weight gain. As peroxisomal proliferation is not relevant for human health hazard the NOAEL relevant for human health is 196 mg/kg bw/day (90 -day study) and 200 mg/kg (2 -generation study). Since a significant increase in exposure time (from 90 to 120 -130 days) did not alter the NOAEL or lead to more severe effects, an additional factor for exposure duration is not required.
Considering the appropriate modification and assessment factors, the worker DNEL (long-term inhalation exposure) is calculated as follows:
Inhalation exposure
Modification into a correct starting point:
Relevant dose descriptor (NOAEL): 200 mg/kg bw/day
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Corrected inhalatory NOAEC for workers
= 200 mg/kg bw/day × 0.5 × (1 / 0.38 m³/kg bwI) × (6.7 m³/10 m³)
= 176.3 mg/m³
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Intraspecies differences: 5
Taking the above mentioned assessment factors into account, the following worker long term inhalation DNEL for systemic effects is:
176.3 mg/m³ / (1 x 1 x 1 x 5) = 176.3 mg/m³ / 5
= 35.3 mg/m³
As the inhalation DNEL for long term local effects is lower than the inhalation DNEL for long term systemic effects, systemic effects are fully covered by the DNEL for long term local effects.
Dermal exposure
Modification into a correct starting point:
Dose descriptor of relevant study: The dermal absorption is considered to be 4%, the oral absorption is considered to be 50%.
Relevant starting point NOAEL dermal = (200 mg/kg bw/day x 0.5) / 0.04 = 2500 mg/kg bw/day
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 4
Intraspecies differences (worker): 5
Taking the above mentioned assessment factors into account, the following worker long- term dermal DNEL for systemic effects is:
2500 mg/kg bw/d / (1 x 1 x 4 x 5) = 2500 mg/kg bw/day / 20
= 125 mg/kg bw/day
References
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010 -G-19 –EN.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There is one repeated dose inhalation study available (BASF, 2013). However, the duration of exposure of this study (5 days) is too short to serve as a reasonable starting point for a longterm DNEL derivation. There are no other relevant experimental data on repeated exposure by inhalation.
Hence, an oral study with dose descriptor modification was used as a starting point (see discussion for further information). A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from 2 generation study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Effects are secondary to altered/enhanced liver metabolism. No organ damage was observed. An additional factor for remaining toxicodynamic differences is not deemed necessary.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- Local effects are related to the deposited concentration rather than the total dose (AUC). Therefore, no AF for exposure duration is applied.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 62.5 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated dermal exposure. Taken into account the available toxicokinetic data, dermal absoption is anticipated to be 4 % and oral absoption is estimated to be 50%.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from 2 generation study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 5 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation is required since a repeated dose oral toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL taken from 2 generation study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
General
DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance (2010). In view of the data used for evaluation, the "quality of whole database factors" and the “factor for remaining uncertainties“ is considered to amount to a value of 1. Based on the available experimental data there is no evidence for interspecies differences in the general mode of action or kinetics. The observed effects are considered secondary to altered / enhanced liver metabolism, which is already covered by the factors for allometric scaling.
Acute/short-term exposure - systemic effects
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As this substance is not classified, no acute DNELs need to be calculated.
Acute/short-term and long-term exposure -local effects
Skin and eye irritation/corrosion and sensitization:
The skin and eye irritation and sensitization potential of the test item was assessed in several in vivo studies. The test item has been demonstrated to be neither irritating nor sensitising.
Respiratory irritation:
A short-term inhalation toxicity study (BASF SE, 2013) revealed that the test substance has irritating properties in the respiratory tract. Based on these findings a long-term inhalation DNEL for local effects is derived. The NOAEC of 50 mg/m³ is identified as the relevant dose descriptor and starting point.
Modification into a correct starting point:
Using a conservative approach, a general population DNEL (long-term inhalation exposure) is derived.
Relevant dose descriptor (NOAEC): 50 mg/m³
Exposure duration rat: 6 h/d
Exposure duration general population: 24 h/d
Corrected inhalatory NOAEC for general population
= 50 mg/m³ × (6 h/d/24 h/d)
= 12.5 mg/m³
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following general population long term inhalation DNEL for local effects is:
12.5 mg/m³ / (1 x 1 x 1 x 10) = 12.5 mg/m³ / 10
= 1.25 mg/m³
Long-term exposure - systemic effects
In a 90-day oral repeated dose toxicity study (BASF, 1995) and an oral 2 generation study (BASF, 2009) in rats, similar NOAELs were identified. Both studies showed peroxisomal proliferation, altered liver metabolism and associated secondary changes in blood parameters, and reduced body weight gain. As peroxisomal proliferation is not relevant for human health hazard the NOAEL relevant for human health is 196 mg/kg bw/day (90 -day study) and 200 mg/kg (2 -generation study). Since a significant increase in exposure time (from 90 to 120 -130 days) did not alter the NOAEL or lead to more severe effects, an additional factor for exposure duration is not required.
Considering the appropriate modification and assessment factors, the worker DNEL (long-term inhalation exposure) is calculated as follows:
Inhalation exposure
Modification into a correct starting point:
Relevant dose descriptor (NOAEL): 200 mg/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Standard respiratory volume of the rat (sRVrat) for 24 hours: 1.15 m³/kg bw
Corrected inhalatory NOAEC for general population
= 200 mg/kg bw/day × 0.5 / 1.15 m³/kg bw
= 87 mg/m³
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following worker long term inhalation DNEL for systemic effects is:
87 mg/m³ / (1 x 1 x 1 x 10) = 87 mg/m³ / 10
= 8.7 mg/m³
As the inhalation DNEL for long term local effects is lower than the inhalation DNEL for long term systemic effects, systemic effects are fully covered by the DNEL for long term local effects.
Dermal exposure
Modification of the dose descriptor
Dose descriptor of relevant study: The dermal absorption is considered to be 4%, the oral absorption is considered to be 50%.
Relevant starting point NOAEL dermal = (200 mg/kg bw/day x 0.5) / 0.04 = 2500 mg/kg bw/day
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 4
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following general population DNEL
(dermal exposure) is 2500 mg/kg bw/d / (1 x 1 x 4 x 10) = 2500 mg/kg bw/day / 40
= 62.5 mg/kg bw/day
Oral exposure
Relevant starting point NOAEL oral = 200 mg/kg bw/day
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 4
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following general population DNEL
(oral exposure) is 200 mg/kg bw/d / (1 x 1 x 4 x 10) = 200 mg/kg bw/day / 40
= 5 mg/kg bw/day
References
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.
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.