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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-596-5 | CAS number: 123-05-7
- 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:
- 1.53 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.62 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Because of the wide use of the substance as an intermediate, long-term oral, dermal and inhalation intakes are the possible exposure routes of 2-ethylhexanal.
The DNELs for long-term exposure are derived from the no observed effect level obtained in a 28 day sub-acute repeated inhalation study, where a NOAEC (systemic effects) of 540 mg/m3/d was estimated (BIBRA 1554/1/3/97). In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in R8 (ECHA, May 2008). For derivation of the inhalative DNEL, the experimental NOAEC had to be corrected for interspecies difference between rat and human by the risk assessors 6h/8h and 6.7 m3/10 m3 regarding exposure time and breathing volume. A corrected inhalation NOAEC of 271.4 mg/m3/d according to the procedure, recommended in the current guidance document was obtained (R8, ECHA 2008).
Additionally an assessment factor (AF) of 75 (interspecies: allometric scaling = 1; remaining differences = 2.5; intraspezies = 5; exposure duration = 6 (subacute to chronic); dose-response = 1; quality of whole database = 1: AF = 1 x 2.5 x 5 x 6 x 1 x 1 = 75) was calculated. Consequently, the inhalative long-term systemic DNEL derived was 3.62 mg/m3/d for the worker.
For derivation of the systemic dermal DNEL, the same NOAEC from the subacute repeated dose study (540 mg/m3/d) was chosen as the point of departure. The inhalative NOAEL was converted into a corrected starting point of 154 mg/m3/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008). It is assumed that there is an adsorption difference of the test material when administered by the dermal and not by the oral route (only 50 % of the doses are adsorbed dermally). Consequently, the assessment factor was multiplied with a factor of 0.5 to obtain an overall assessment factor for the dermal DNEL. As a result an assessment factor (AF) of 150 (interspezies: allometric scaling = 4; remaining differences = 2.5; intraspezies = 5; exposure duration = 6 (subacute to chronic); dose-response = 1; quality of whole database = 1; adsorbtion difference = 0.5: AF = 4 x 2.5 x 5 x 6 x 1 x 1 x 0.5 = 150) was calculated. The dermal long-term systemic DNEL derived was 1.53 mg/kg bw/d for the worker.
2-Ethylhexanal is in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 classified as eye and skin irritant (Cat. 2). Furthermore, from the read across to 2-ethylhex-2-enal (CAS 645-62-5) a skin sensitising potential is assumed. The performed guideline tests are not providing dose-response data that could be used for the derivation of a DNEL.
According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoints. In order to guarantee "adequately control of risks", it is necessary to stipulate risk management measures that prevent eye and skin exposure.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.64 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.37 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.18 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For the consumer, the same general considerations for the calculation of DNELs were taken into account as already mentioned above for the worker. Therefore, also here the subacute repeated inhalation study was taken for derivation of the inhalation long term systemic DNEL.
The derivation of the inhalative DNEL requires the conversion of the experimental NOAEC into a corrected inhalative NOAEC of 96.4 mg/m3/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008). Additionally an assessment factor (AF) of 150 (interspezies: allometric scaling = 1; remaining differences = 2.5; intraspezies = 10; exposure duration = 6 (subacute to chronic); dose-response = 1; quality of whole database = 1: AF = 1 x 2.5 x 10 x 6 x 1 x 1 = 150) was calculated. Consequently, the inhalative long-term systemic DNEL derived was 0.64 mg/m3/d for the consumer.
For derivation of the systemic dermal and oral DNEL for the general population, the same NOAEC from a the 28 day subacute repeated dose study (540 mg/m3/d) was chosen as the point of departure and a corrected starting point of 110.9 mg/kg bw/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008) was calculated. The following assessment factor (AF) for the oral DNEL were applied: Interspezies: allometric scaling = 4; remaining differences = 2.5; intraspezies = 10; exposure duration = 6 (subacute to chronic); dose-response = 1; quality of whole database = 1: AF = 4 x 2.5 x 10 x 6 x 1 x 1 = 600.
The resulting DNEL for long-term oral systemic effects of 2-ethylhexanal was 0.18 mg/kg bw/d for the general population. Additionally, it is assumed that there is an adsorption difference of the test material when administered by the dermal and not by the oral route (only 50 % of the doses are adsorbed dermally). Consequently, the assessment factor was multiplied with a factor of 0.5 to obtain an overall assessment factor of 300. The dermal long-term systemic DNEL derived was 0.37 mg/kg bw/d for the consumer.
The observed skin irritation effects are caused by a threshold mode of action, but the available data do not allow identifying the threshold. Due to the design of the study these tests only provide potency data (scores for skin are reported for one tested concentration), but do not provide dose-response data which would support determination of a DNEL. Therefore, a qualitative assessment of the available data is conducted in terms of irritant/corrosive properties: Based on the available results on skin and eye irritation 2-diethylaminoethanol has to be considered as irritating (EU R36/38; GHS Cat. 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.
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.