Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 609-066-0 | CAS number: 35123-06-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 78.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance, ECETOC Technical Report No. 110 and Batke et al (2011)
- Overall assessment factor (AF):
- 4.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 352.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- 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:
- 1.5
- Justification:
- An extrapolation factor based on experimental data is used: subchronic (starting point) to chronic (end point).
- 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:
- An additional factor for "remaining interspecies differences" is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies differences of worker are considered to be fully covered by the selected 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 aassessment factors are required.
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.11 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance, ECETOC Technical Report No. 110 and Batke et al (2011)
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by dermal absorption. Based on the physiochemical properties it is assumed that the test item absorption corresponds to a worst case of 100 % of the oral uptake.
- 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:
- 1.5
- Justification:
- An extrapolation factor based on experimental data 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:
- 1
- Justification:
- An additional factor for "remaining interspecies differences" is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies differences of worker are considered to be fully covered by the selected 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 aassessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA REACH Guidance (2010), ECETOC (2010) and Batke et al (2011).In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1.
Long term exposure- systemic effects
Inhalation exposure
In order to derive the worker DNEL (long- term inhalation exposure), the NOAEL assessed in the key 90-day repeated dose oral toxicity study was used as relevant dose descriptor (NOAEL = 200 mg/kg bw/day).The oral NOAEL was converted to an inhalation NOAEC, assuming 100 % absorption via the lung and via the oral route.
Inhalation NOAEC = oral NOAEL x 1/sRV (rat) x ABS oral (rat)/ ABS inhalation (human) x sRV (human)/ wRV (human)
Correction of the dose descriptor
Oral NOAEL: 200 mg/kg bw/ day
sRV(rat): 0.38 m3/kg bw (8 hours) [standard respiratory volume of the rat]
ABSoral(rat)/ABSinhalation(human): 1 [ratio of oral absorption in the rat to inhalative absorption in the human]
sRV (human)/ wRV (human): 6.7 m3/ 10 m3[ratio of human standard respiratory volume to worker respiratory volume]
The oral NOAEL= 200 mg/kg bw/ day is converted in an inhalation NOAEC= 352.63 mg/ m3
Calculation of the worker DNEL
Corrected inhalatory NOAEC for worker: 352.63 mg/ m³
Assessment factor for exposure duration (subchronic to chronic): 1.5
Assessment factor for intraspecies differences (worker): 3
Worker DNEL (inhalation exposure) = 352.63 mg/ m3/ (1 x 1.5 x 1 x 3 x 1 x 1 x 1) = 352.63 mg/ m3/ 4.5 = 78.36 mg/ m3
Dermal exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the 90-day repeated dose oral toxicity study is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the worker DNEL (long-term dermal exposure) is calculated as follows:
Relevant dose descriptor of relevant study: 200 mg/kg bw/ day (assuming 100 % dermal absoprtion)
Route to route extrapolation (oral to dermal): 1
Exposure duration factor (subchronic-to-chronic): 1.5
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (worker): 3
Worker DNEL (long-term dermal exposure): 200 mg/kg bw/day / (1 x 1.5 x 4 x 3 x 1 x 1 x 1) = 200 / 18 = 11,11 mg/kg bw/day
Acute exposure- systemic effect
A short-term DNEL systemic is not required as the acute oral, inhalation and dermal toxicity of the test item is considered to be very low and no classification and labelling was required according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
Acute/ long term exposure- local
Skin irritation/corrosion: A long-term and acute DNEL local is not required as the local toxicity of the the test item is not classified for skin irritation/corrosion according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
Eye irritation: The test item is not classified for eye irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP). Thus, no local DNEL was derived.
Skin sensitization: The test item is not classified as a skin sensitizer according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
Respiratory irritation: As no eye and skin irritation/ corrosion properties were identified in the available studies and uptake via inhalation is unlikely to occur, no DNEL was derived. In addition, in an acute inhalation study, no local respiratory irritation was observed.
References
(not included as endpoint study record)
- 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.
- ECETOC (2010). Technical Report 110.Guidance on assessment factors to derive a DNEL.
according to Annex VI of Regulation EC 1272/2008 (CLP).
- Batke (2011). Evaluation of time extrapolation factors based on the database RepDose. Toxicology Letters 205, 122– 129
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance, ECETOC Technical Report No. 110 and Batke et al (2011)
- Overall assessment factor (AF):
- 7.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 150 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- 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:
- 1.5
- Justification:
- An extrapolation factor based on experimental data is used: subchronic (starting point) to chronic (end point).
- 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:
- An additional factor for "remaining interspecies differences" is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected 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 aassessment factors are required.
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance, ECETOC Technical Report No. 110 and Batke et al (2011)
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by dermal absorption. Based on the physiochemical properties it is assumed that the test item absorption corresponds to a worst case of 100 % of the oral uptake.
- 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:
- 1.5
- Justification:
- An extrapolation factor based on experimental data 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:
- 1
- Justification:
- An additional factor for "remaining interspecies differences" is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected 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 aassessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH Guidance and ECETOC Technical Report No.110
- Overall assessment factor (AF):
- 30
- 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 necessary 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:
- 1.5
- Justification:
- An extrapolation factor based on experimental data 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:
- 1
- Justification:
- An additional factor for "remaining interspecies differences" is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies differences of general population are considered to be fully covered by the selected 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 aassessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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 test item is performed under consideration of the recommendations of ECHA REACH Guidance (2010), ECETOC (2010) and Batke et al (2011). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1.
Long term exposure- systemic effects
Inhalation exposure
The derived general population DNEL (long-term inhalation exposure) is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected). The NOAEL assessed in the 90-day repeated dose oral toxicity study is identified as the relevant dose descriptor.
Modification of the starting point
Relevant dose descriptor (NOAEL): 200 mg/kg bw/ day
Allometric scaling: 4
Body weight: 60 kg
Standard respiratory volume of humans (sRV human) for 24 hours: 20 m³
Oral absorption of the rat / inhalation absorption of humans (ABS oral-rat / ABS inh- human): 1
Corrected inhalatory NOAEC for general population: (200 mg/kg bw/day / 4) × 60 kg/ 20 m3/ day × 1 = 150 mg/ m³
Calculation of the general population DNEL
Corrected inhalatory NOAEC for general population: 150 mg/m³
Assessment factor for exposure duration (subchronic to chronic): 1.5
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term inhalation exposure) = 150 mg/m³ / (1x 1.5 x 1 x 1 x 5 x 1 x 1 ) = 150 mg/m³ / 7.5 = 20 mg/m³
Dermal exposure
In order to derive the general population DNEL (long-term dermal exposure), the NOAEL assessed in the 90-day repeated dose oral toxicity study is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the general population DNEL (long-term dermal exposure) is calculated as follows:
Relevant dose descriptor of relevant study: 200 mg/kg bw/ day (assuming 100 % dermal absoprtion)
Route to route extrapolation (oral to dermal): 1
Exposure duration factor (subchronic-to-chronic): 1.5
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term dermal exposure): 200 mg/kg bw/day / (1 x 1.5 x 4 x 5 x 1 x 1 x 1) = 6.67 mg/kg bw/ day
Oral exposure
In order to derive the general population DNEL (long-term oral exposure), the NOAEL assessed in the 90-day repeated dose oral toxicity study is identified as the relevant dose descriptor. Considering the appropriate modification and assessment factors, the general population DNEL (long-term oral exposure) is calculated as follows:
Relevant dose descriptor (NOAEL): 200 mg/kg bw/ day
Exposure duration factor (subchronic-to-chronic): 1.5
Allometric scaling factor (rat-to-human): 4
Assessment factor for intraspecies differences (general population): 5
General population DNEL (long-term dermal exposure) = 200 mg/kg bw/day / (2 x 4 x 5 x 1 x 1 x 1) = 6.67 mg/kg bw/day
Acute/ short-term- systemic effects
Short-term DNELs are not required as there is no acute toxicity of the test item. It is not classified and labelled for acute systemic toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), based on the test data for acute oral, dermal and inhalation toxicity.
Acute/ long-term- local effects
Skin and eye irritation/corrosion: The test item is not classified for skin and eye irritation based on the results of the skin and eye irritation studies available. Therefore, no DNEL was derived.
Skin sensitisation: The test item is not classified as a skin sensitizer based on the results of the skin sensitisation study available. Therefore, no DNEL was derived.
Respiratory irritation: As no eye and skin irritation/ corrosion properties were identified in the available studies and uptake via inhalation is unlikely to occur, no DNEL was derived. In addition, in an acute inhalation study, no local respiratory irritation was observed.
References
(not included as endpoint study record)
- 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.
- ECETOC (2010). Technical Report 110.Guidance on assessment factors to derive a DNEL.
according to Annex VI of Regulation EC 1272/2008 (CLP).
- Batke (2011). Evaluation of time extrapolation factors based on the database RepDose. Toxicology Letters 205, 122– 129
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)