Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 800-696-3 | CAS number: 78605-96-6
- 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:
- 3.71 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 278.05 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 60 mg/kg bw/day derived from OECD 414 was used. Even though the NOAEL from the 90 -day study was lower i.e. 30 mg/kg bw/day, this data quality was inadequate as the the effects on liver and kidney was observed at the highest dose of 287.3 mg/kg bw/day (female) and 320.3 mg/kg bw/day (male) with the middle doses of 29.9 mg/kg bw and 34.9 mg/kg bw/day. The difference between the mid and high doses was considered too wide and further more the effects on the organ weights was not accompanied by any histopathological finding, it was therefore considered adoptive response not treatment effects.
Regarding absorption, 83% absorption for starting route (oral) was used and the end route (inhalation), worst-case assumptions were made i.e. 100% was considered in line with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (2012).
To convert the oral NOAEL into inhalatory NOAEC, a rabbit default respiratory volume in accordance with TGD (2003) an inhalation volume of 750ml/min has been used for the rabbit (3kg) resulting in a sRVrabbit of 250ml/min/kg.
For an exposure of 8h per day the following can be assumed:
sRVrabbit(8h) = 0.00025m3/min/kg * 60min * 8h = 0,12 m3/kg
Corrected Inhalatory NOAEC = [NOAEL] X (1/sRVrat x ABS(oral-rat)/ABS(inh-human) x sRVhuman/wRV
Therefore; 60 mg/kg bw/day * [1/0.12 m3/kg] * [83/100]*[6.7m3/10m3] = 278.05 mg/m3 NOAEC for workers.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance. Assessment factor not to be used for inhalation route since the differences in the metabolic rate/bw has already been taken into account in the corrected dose descriptor.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- 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:
- no hazard identified
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:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long-term dermal systemic DNEL values are derived from the systemic NOAEL of 125 mg/kg bw/d from a 90 -day rat dermal toxicity study; this approach is conservative as it is likely that the effects seen in this study are secondary to oral ingestion of the test material.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for rats. Table R.8-4 ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- 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:
- 0.24 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- other: NOAEC
- AF for dose response relationship:
- 1
- Justification:
- default value: use of a NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- value appropriate for sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- appropriate for local effects
- AF for other interspecies differences:
- 1
- Justification:
- use of a human study
- AF for intraspecies differences:
- 5
- Justification:
- default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 10
- Justification:
- additional sensitisation-specific factor to take into account uncertainties regarding the sensitivity of different skin areas and the potential for mixture effects on sensitisation
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.24 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- other: NOAEC
- AF for dose response relationship:
- 1
- Justification:
- default value: use of a NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- appropriate for local effects
- AF for other interspecies differences:
- 1
- Justification:
- use of a human study
- AF for intraspecies differences:
- 5
- Justification:
- default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 10
- Justification:
- additional sensitisation-specific factor to take into account uncertainties regarding the sensitivity of different skin areas and the potential for mixture effects on sensitisation
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
DNEL values are derived using the approach recommended by ECHA and default assessment factors.
The long-term inhalation systemic DNEL value is derived from the systemic NOAEL of 30 mg/kg bw/d from an OECD 414 oral developmental study in rabbit and a corrected (inhalation) starting point of 278.05 mg/m3 derived taking into account breathing rate (1\0.38*0.67) and the extent of oral absorption (83%) and assumed inhalation absorption (100%).
A short-term inhalation systemic DNEL is not derived in the absence of any acute hazard.
Inhalation local dermal DNEL values are not derived in the absence of any indication of a hazard or relevant data.
A long-term dermal systemic DNEL value is derived from the systemic NOAEL of 125 mg/kg bw/d from a 90 -day rat dermal toxicity study; this approach is conservative as it is likely that the effects seen in this study are secondary to oral ingestion of the test material.
A short-term dermal systemic DNEL is not derived in the absence of any acute hazard.
Although a lower oral NOAEL of 30 mg/kg bw/d was identified in a rat from the 90 day oral toxicity study, this data quality was inadequate as the the effects on liver and kidney was observed at the highest dose of 287.3 mg/kg bw/day (female) and 320.3 mg/kg bw/day (male) with the middle doses of 29.9 mg/kg bw and 34.9 mg/kg bw/day. The difference between the mid and high doses was considered too wide and furthermore the effects on the organ weights was not accompanied by any histopathological finding, it was therefore considered adoptive response not treatment effects.
Amyl cinnamic aldehyde ( 2-benzylideneheptanal; EC number :204-541-5; CAS Number: 122-40-7)is identified as a potential skin sensitizer in a mouse LLNA (EC3 = 7.6%; 1900 µg/cm2. A significant number of studies of skin sensitisation in human subjects are available; some studies report a low response incident, however the two most reliable HRIPT studies report a 0% incidence of sensitisation reactions in approximately 200 subjects. These studies used 0.3 mL of 20% amyl cinnamic aldehyde in a 25 mm diameters chamber; the amount of substance applied in these studies is therefore 0.06 mL (~60 mg) or approximately 12 mg/cm2. This is considered to be the NOAEC.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.922 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 138.33 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 60 mg/kg bw/day derived from OECD 414 was used. Even though the NOAEL from the 90 -day study was lower i.e. 30 mg/kg bw/day, this data quality was inadequate as the the effects on liver and kidney was observed at the highest dose of 287.3 mg/kg bw/day (female) and 320.3 mg/kg bw/day (male) with the middle doses of 29.9 mg/kg bw and 34.9 mg/kg bw/day. The difference between the mid and high doses was considered too wide and furthermore the effects on the organ weights was not accompanied by any histopathological finding, it was therefore considered adoptive response not treatment effects.
Regarding absorption, 83% absorption for starting route (oral) was used and the end route (inhalation), worst-case assumptions were made i.e. 100% was considered in line with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (2012).
To convert the oral NOAEL into inhalatory NOAEC, a rabbit default respiratory volume in accordance with TGD (2003) an inhalation volume of 750ml/min has been used for the rabbit (3kg) resulting in a sRVrabbit of 250ml/min/kg.
Corrected inhalatory NOAEC = Oral NOAEL * [1/sRVrabbit] * [ABSoral-rat/ABSinh-human]
For an exposure of 8h per day the following can be assumed:
sRVrabbit(24h) = 0.00025m3/min/kg * 60min * 24h = 0.36 m3/kg/day
Therefore; = 60 mg/kg bw/day * [1/0.36 m3/kg]* [83/100]*[6.7m3/10m3] = 138.33 mg/m3 NOAEC general population
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance. Assessment factor not to be used for inhalation route since the differences in metabolic rate/bw has already been taken into account for the corrected dose descriptor.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band.
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.625 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 125 mg/kg bw/d for systemic effects was identified in a OECD 411 rats study. Applying assessment factors of 1 (default value for dose-response relationship), 2 (for duration, to cover extrapolation from a sub-acute study to a chronic endpoint), 4 (for allometric differences), 2.5 (default for interspecies differences) and 10 (default for intraspecies differences), 1 ( for quality of database) and 1 (remaining uncertainties) results in a DNEL value of 0.625 mg/kg bw/d.
For more information refer to "Additional information - general population".
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for rats. Table R.8-4 ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band.
- 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:
- 0.12 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor:
- other: NOAEC
- AF for dose response relationship:
- 1
- Justification:
- default value: use of a NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- value appropriate for sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- appropriate for local effects
- AF for other interspecies differences:
- 1
- Justification:
- use of a human study
- AF for intraspecies differences:
- 10
- Justification:
- default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 10
- Justification:
- additional sensitisation-specific factor to take into account uncertainties regarding the sensitivity of different skin areas and the potential for mixture effects on sensitisation
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.12 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- other: NOAEC
- AF for dose response relationship:
- 1
- Justification:
- default value: use of a NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- appropriate for local effects
- AF for other interspecies differences:
- 1
- Justification:
- use of a human study
- AF for intraspecies differences:
- 10
- Justification:
- default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 10
- Justification:
- additional sensitisation-specific factor to take into account uncertainties regarding the sensitivity of different skin areas and the potential for mixture effects on sensitisation
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.167 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):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Results available from sub-acute rabbit oral toxicity study, no route-to-route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Default allometric scaling factor for rabbits. Table R.8-4 ECHA REACH Guidance..
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population. Table R.8-6 ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNEL values are derived using the approach recommended by ECHA and default assessment factors.
The long-term inhalation systemic DNEL value is derived from the systemic NOAEL of 30 mg/kg bw/d from an OECD 414 oral developmental study in rabbit and a corrected (inhalation) starting point of 278.05 mg/m3 derived taking into account breathing rate (1\0.38*0.67) and the extent of oral absorption (83%) and assumed inhalation absorption (100%).
A short-term inhalation systemic DNEL is not derived in the absence of any acute hazard.
Inhalation local dermal DNEL values are not derived in the absence of any indication of a hazard or relevant data.
A long-term dermal systemic DNEL value is derived from the systemic NOAEL of 125 mg/kg bw/d from a 90 -day rat dermal toxicity study; this approach is conservative as it is likely that the effects seen in this study are secondary to oral ingestion of the test material.
A short-term dermal systemic DNEL is not derived in the absence of any acute hazard.
Although a lower oral NOAEL of 30 mg/kg bw/d was identified in a rat from the 90 day oral toxicity study, this data quality was inadequate as the the effects on liver and kidney was observed at the highest dose of 287.3 mg/kg bw/day (female) and 320.3 mg/kg bw/day (male) with the middle doses of 29.9 mg/kg bw and 34.9 mg/kg bw/day. The difference between the mid and high doses was considered too wide and furthermore the effects on the organ weights was not accompanied by any histopathological finding, it was therefore considered adoptive response not treatment effects.
Amyl cinnamic aldehyde ( 2-benzylideneheptanal; EC number :204-541-5; CAS Number: 122-40-7)is identified as a potential skin sensitizer in a mouse LLNA (EC3 = 7.6%; 1900 µg/cm2. A significant number of studies of skin sensitisation in human subjects are available; some studies report a low response incident, however the two most reliable HRIPT studies report a 0% incidence of sensitisation reactions in approximately 200 subjects. These studies used 0.3 mL of 20% amyl cinnamic aldehyde in a 25 mm diameters chamber; the amount of substance applied in these studies is therefore 0.06 mL (~60 mg) or approximately 12 mg/cm2. This is considered to be the NOAEC.
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.
