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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-983-6 | CAS number: 112-54-9
- 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
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:
- 49.7 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 242 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- R.8 Example B. 3 Modification of the starting point
- AF for dose response relationship:
- 1
- Justification:
- Default based on NOAEL starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required as this is taken into account by conversion from oral to inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Based on good quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.1 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Example B. 5 Dermal exposure; oral N(L)OAEL rat
- AF for dose response relationship:
- 1
- Justification:
- Default based on NOAEL starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
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:
- 0.57 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3 000
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 3
- Justification:
- LOAEL
- AF for differences in duration of exposure:
- 10
- Justification:
- specific R.8 page 125
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- specific R.8 page 125
- AF for other interspecies differences:
- 1
- Justification:
- accounted for above
- AF for intraspecies differences:
- 5
- Justification:
- worker default
- AF for the quality of the whole database:
- 2
- Justification:
- read across
- AF for remaining uncertainties:
- 1
- Justification:
- specific: matrix effect R.8 page 125
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Worker-Inhalation-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 7 mg/m3
Worker-Inhalation-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
Worker-Inhalation-Long-term-Local
No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
Worker-Inhalation-Acute-Local
No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
Worker-Dermal-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of mg/m3
Worker-Dermal-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
Worker-Dermal-Long-term-Local
sensitisation endpoint has been waived on animal welfare grounds with reference to undec-10-enal and 2-methylundecanal results. The EC3 value was determined to be 6.8 and 10% respectively, as such the value of 6.8 % shall be used here.
LLNA shows an EC3 of 10 %, according to Guidance R.8-10 this can be used to calculate a corrected LOAEL for the purposes of calculating a DNEL, provided specific assessment factors are used as above.
Worker-Dermal-Acute-Local
The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.
Worker-Hazard for eyes
Classified as eye irritant (Category 2)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.3 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 613 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- R.8 Example B. 3 Modification of the starting point
- AF for dose response relationship:
- 1
- Justification:
- Default based on NOAEL starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic default value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required as this is taken into account by conversion from oral to inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Example B. 5 Dermal exposure; oral N(L)OAEL rat
- AF for dose response relationship:
- 1
- Justification:
- Default based on NOAEL starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic default value
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.28 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6 000
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 3
- Justification:
- LOAEL
- AF for differences in duration of exposure:
- 10
- Justification:
- specific R.8 page 125
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- specific R.8 page 125
- AF for other interspecies differences:
- 1
- Justification:
- accounted for above
- AF for intraspecies differences:
- 10
- Justification:
- General Population default
- AF for the quality of the whole database:
- 2
- Justification:
- read across
- AF for remaining uncertainties:
- 1
- Justification:
- specific: matrix effect R.8 page 125
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No starting point modification required
- AF for dose response relationship:
- 1
- Justification:
- Default based on NOAEL starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
General Population-Inhalation-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 12.3 mg/m3
General Population-Inhalation-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General Population-Inhalation-Long-term-Local
No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
General Population-Inhalation-Acute-Local
No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
General Population-Dermal-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 7.0 mg/m3
General Population-Dermal-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General Population-Dermal-Long-term-Local
sensitisation endpoint has been waived on animal welfare grounds with reference to undec-10-enal and 2-methylundecanal results. The EC3 value was determined to be 6.8 and 10% respectively, as such the value of 6.8 % shall be used here.
LLNA shows an EC3 of 10 %, according to Guidance R.8-10 this can be used to calculate a corrected LOAEL for the purposes of calculating a DNEL, provided specific assessment factors are used as above.
General Population-Dermal-Acute-Local
The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.
General Population-Oral-Long-term-Systemic
NOEL provided by 90d study. The above factors were used to calculate a DNEL of 0.28 mg/m3
General Population-Oral-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General Population-Hazard for eyes
Classified as eye irritant (Category 2)
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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