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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-778-7 | CAS number: 70693-62-8
- 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:
- no hazard identified
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:
- 0.112 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor:
- NOAEC
- Value:
- 1.4 mg/m³
- 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 independent from time.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effects are independent from metabolic rate.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- 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:
- 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no experimental data on repeated dermal exposure. Based on the physicochmical properties, especially the low log Pow value (<0), dermal absorption is anticipated to be low. However, the substance is corrosive to skin, which may enhance penetration. Therefore a dermal absorption rate of 50 % of the oral absorption rate was taken for calculation.
- 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:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- 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:
- 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 - Worker
DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance (2012). 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.
Short-term, local DNEL
The skin and eye irritation and sensitization potential of the test item was assessed in several studies. The test item demonstrated to be corrosive to skin and causing serious damage to the eyes. Thus, a qualitative risk assessment was performed.
Short-term, systemic DNEL
The guidance on dose/concentration response regarding human health (section R.8.1.2.5 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 Regulation (EC) No 1272/2008 (CLP). As this substance is not classified for short-term inhalative or dermal systemic effects, no acute systemic DNELs need to be calculated for those exposure routes.
Long-term, local DNEL
Inhalation exposure
A subacute inhalation toxicity study revealed no effects with regard to the respiratory tract, but based on local findings in the eyes a NOAEC of 1.4 mg/m³ is identified as the relevant dose descriptor and starting point for DNEL calculation. A long-term inhalation DNEL for local effects is derived.
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Other interspecies differences: 2.5
Intraspecies differences (worker): 5
Taking the above mentioned assessment factors into account, the following worker long-term inhalation DNEL for local effects is:
1.4 mg/m³ / (1 x 1 x 2.5 x 5) =10.3 mg/m³ / 12.5
= 0.112 mg/m³
Dermal exposure
The skin irritation and sensitization potential of the test item was assessed in several in vivo studies. The test item demonstrated to be corrosive to skin and causing serious damage to the eyes. Thus, a qualitative risk assessment was performed.
Long-term, systemic DNEL
Inhalation exposure
In the subacute repeated dose toxicity study, the substance caused primary local toxicity effects. All observed systemic effects were of secondary nature. Therefore no DNEL, systemic, long-term was derived for inhalation. The systemic exposure is sufficiently covered by the long-term local DNEL.
Dermal exposure
In order to derive the general population DNEL (long-term dermal exposure), the NOAEL assessed in the 90 d repeated dose oral toxicity study (200 mg/kg bw/d) is identified as the relevant dose descriptor.
Modification into a correct starting point:
Correction for dermal absorption rates of the test substance (based on Guidance on information requirements and chemical safety assessment, Chapter R 7.12): Dermal absorption is supposed to be low for several reasons: With a low log Pow (below 0) and a water solubility above 10 g/L the substance is to hydrophilic to cross the lipid rich environment of the stratum corneum. Thus, dermal uptake is anticipated to be low. In addition, the results of the acute dermal toxicity support a low absorption via dermal route. Nonetheless the substance causes skin corrosion. Therefore, dermal absorption was calculated to be 50% of oral absorption.
In conclusion, dermal NOAEL = oral NOAEL x 100/50 =
200 x (100/50) = 400 mg/kg bw/d.
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 2
Interspecies differences (allometric scaling): 4
Remaining interspecies differences: 2.5
Intraspecies differences (worker): 5
Taking the above mentioned assessment factors into account, the following worker long- term dermal DNEL for systemic effects is:
400 mg/kg bw/d / (1 x 2 x 4 x 2.5 x 5) = 400 mg/kg bw/day / 100
= 4 mg/kg bw/day
References
- ECHA (2012). 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.
- ECHA (2016). Guidance on Information Requirements and Chemical Safety Assessment Part E: Risk Characterisation. Version 3. ECHA-2016-G-04-EN
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.056 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
- Value:
- 1.4 mg/m³
- 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 independent from time.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effects are independent from metabolic rate.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- 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:
- 2 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. A low dermal absorption value can be expected due to the physico- chemical properties However the substance shows skin corrosive properties. Therefore, dermal absorption is anticipated to be 50 % of oral absorption.
- 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:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- 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:
- 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- 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:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- LOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
Short-term, local DNEL
The skin and eye irritation and sensitization potential of the test item was assessed in several studies. The test item demonstrated to be corrosive to skin and causing serious damage to the eyes. Thus, a qualitative risk assessment was performed.
Short-term, systemic DNEL
The guidance on dose/concentration response regarding human health (section R.8.1.2.5 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 Regulation (EC) No 1272/2008 (CLP). As this substance is not classified for short-term inhalative or dermal systemic effects, no acute systemic DNELs need to be calculated for those exposure routes.
The substance is classified as harmful if swallowed (H302). Thus, short term oral DNEL is derived for the general population taking the long-term DNEL as basis.
Long-term, local DNEL
Inhalation exposure
A subacute inhalation toxicity study revealed no effects with regard to the respiratory tract, but based on local findings in the eyes a NOAEC of 1.4 mg/m³ is identified as the relevant dose descriptor and starting point for DNEL calculation. A long-term inhalation DNEL for local effects is derived.
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 1
Interspecies differences (allometric scaling): 1
Other interspecies differences: 2.5
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following worker long-term inhalation DNEL for local effects is:
1.4 mg/m³ / (1 x 1 x 2.5 x 10) =1.4 mg/m³ / 25
= 0.056 mg/m³
Dermal exposure
The skin irritation and sensitization potential of the test item was assessed in several in vivo studies. The test item demonstrated to be corrosive to skin and causing serious damage to the eyes. Thus, a qualitative risk assessment was performed.
Long-term, systemic DNEL
Inhalation exposure
In the subacute repeated dose toxicity study, the substance caused primary local toxicity effects. All observed systemic effects were of secondary nature. Therefore no DNEL, systemic, long-term was derived for inhalation. The systemic exposure is sufficiently covered by the long-term local DNEL.
Dermal exposure
In order to derive the general population DNEL (long-term dermal exposure), the NOAEL assessed in the 90 d repeated dose oral toxicity study (200 mg/kg bw/d) is identified as the relevant dose descriptor.
Modification into a correct starting point:
Correction for dermal absorption rates of the test substance (based on Guidance on information requirements and chemical safety assessment, Chapter R 7.12): Dermal absorption is supposed to be low for several reasons: With a low log Pow (below 0) and a water solubility above 10 g/L the substance is to hydrophilic to cross the lipid rich environment of the stratum corneum. Thus, dermal uptake is anticipated to be low. In addition, the results of the acute dermal toxicity support a low absorption via dermal route. Nonetheless the substance causes skin corrosion. Therefore, dermal absorption was calculated to be 50% of oral absorption.
In conclusion, dermal NOAEL = oral NOAEL x 100/50 =
200 x (100/50) = 400 mg/kg bw/d.
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 2
Interspecies differences (allometric scaling): 4
Remaining interspecies differences: 2.5
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following worker long- term dermal DNEL for systemic effects is:
400 mg/kg bw/d / (1 x 2 x 4 x 2.5 x 10) = 400 mg/kg bw/day / 200
= 2 mg/kg bw/day
Oral exposure
In order to derive the general population DNEL (long-term oral exposure), the NOAEL assessed in the subchronic repeated dose oral toxicity study (200 mg/kg bw/d) is identified as the relevant dose descriptor. No modification of the starting point is necessary.
Assessment factors:
Dose response differences: 1
Differences in exposure duration: 2
Interspecies differences (allometric scaling): 4
Remaining interspecies differences: 2.5
Intraspecies differences (general population): 10
Taking the above mentioned assessment factors into account, the following worker long- term dermal DNEL for systemic effects is:
200 mg/kg bw/d / (1 x 2 x 4 x 2.5 x 10) = 200 mg/kg bw/day / 200
= 1 mg/kg bw/day
References
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1. ECHA-2010 -G-19 –EN.
- ECHA (2016). Guidance on Information Requirements and Chemical Safety Assessment Part E: Risk Characterisation. Version 3. ECHA-2016-G-04-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.
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