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Diss Factsheets
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EC number: 204-688-5 | CAS number: 124-19-6
- 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
Endpoint summary
Administrative data
Description of key information
A study on the analogue substance was assessed for repeated dose oral toxicity according to OECD 408.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1 409.7 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In lieu of repeat dose data on nonanal, data are presented for the analogue substance dodecanal. The dodecanal NOAEL was 20000 ppm, equivalent to 1409.7 mg/kg bw/d.
The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.
The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profile, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific. Therefore read-across is justified.
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
The test substance was assessed for repeated oral dose toxicity
according to OECD 408.
Justification for selection of repeated dose toxicity inhalation -
systemic effects endpoint:
In line with Column 2, point 8.6.1, Annex VIII of Regulation
1907/2006, a repeat-dose inhalation study does not need to be performed
as the substance has low vapour pressure and high melting point, so the
potential for the generation of inhalable forms is low. The use of this
substance should not result in aerosols, particles or droplets of an
inhalable size, so exposure to humans via the inhalatory route will be
unlikely to occur, and a repeat-dose inhalation study is not required.
As an objective of Regulation EC No. 1907/2006 is to reduce, replace or
refine animal testing, based on the above information and information in
this dossier, it can be reasonably expected that inhalation exposure is
not expected and as such, further investigation using vertebrate animals
is therefore considered unnecessary.
Justification for selection of repeated dose toxicity inhalation -
local effects endpoint:
In line with Column 2, point 8.6.1, Annex VIII of Regulation
1907/2006, a repeat-dose inhalation study does not need to be performed
as the substance has low vapour pressure and high melting point, so the
potential for the generation of inhalable forms is low. The use of this
substance should not result in aerosols, particles or droplets of an
inhalable size, so exposure to humans via the inhalatory route will be
unlikely to occur, and a repeat-dose inhalation study is not required.
As an objective of Regulation EC No. 1907/2006 is to reduce, replace or
refine animal testing, based on the above information and information in
this dossier, it can be reasonably expected that inhalation exposure is
not expected and as such, further investigation using vertebrate animals
is therefore considered unnecessary.
Justification for selection of repeated dose toxicity dermal -
systemic effects endpoint:
The physicochemical and toxicological properties suggest low
potential for significant rate of absorption through the skin.
Furthermore the results of laboratory animal studies show low acute
dermal toxicity. In a 90 - days repeated dose study on the analogue
substances, undec10-enal and Dodecanal, via dietary administration, the
test substance did not exacerbate systemic toxicity effects which
suggest bioavailability is low, therefore there is low toxicity
potential. This intrinsic property/toxicity potential can be
extrapolated to repeated dermal route administration. Furthermore,
contact with neat substance will be prevented by risk mitigation
measures in the modern industrial setting. Further investigation using
vertebrate animals is therefore considered unnecessary.
Justification for selection of repeated dose toxicity dermal - local
effects endpoint:
The physicochemical and toxicological properties suggest low
potential for significant rate of absorption through the skin.
Furthermore the results of laboratory animal studies show low acute
dermal toxicity. In a 90 - days repeated dose study on the analogue
substance, undec10-enal, via dietary administration, the test substance
does not exacerbate systemic toxicity effects which suggest
bioavailability is low, therefore there is low toxicity potential. This
intrinsic property/toxicity potential can be extrapolated to repeated
dermal route administration. Furthermore, contact with neat substance
will be prevented by risk mitigation measures in the modern industrial
setting. Further investigation using vertebrate animals is therefore
considered unnecessary.
Justification for classification or non-classification
The analogue substance, Dodecanal, was assessed for repeated dose oral toxicity according to OECD 408. The No Observed Adverse Effect Level (NOAEL) for the rat was considered to be 20000 ppm, equivalent to 1409.7 mg/kg bw/d.
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.