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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-283-8 | CAS number: 19766-89-3
- 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:
- 14 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- other: NOAEL
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:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Additional information - workers
Short term exposure worker (systemic effects)
It is not possible to derive a DNEL for acute effects based on the available data. The acute toxicity of 2-ethylhexanoic acid, the source substance of the read across approach (for read across justification please refer to IUCLID chapter 13) is low with respect to the oral, dermal and inhalative routes of exposure. There is no acute risk to be expected from inhalation since an inhalation hazard test showed no mortality and no clinical signs after 8h exposure to saturated vapor. Furthermore, there are no uses with inhalable aerosol formation.
Long term exposure worker (systemic effects)
The DNELs for inhalation and dermal long term exposure are derived from the NOAEL (100 mg/kg bw) obtained in the oral reproductive and developmental toxicity studies (see chapter “toxicity for reproduction”).
Long term worker (systemic, inhalation)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414/415; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/0.38 |
Route to route (8h exposure) |
|
1/1 |
Absorption oral to inhal. (complete absorption after oral uptake assumed according to toxicokinetic study) |
|
6.7 m³/10 m³ |
Correction to light work |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
1 |
No interspecies extrapolation for inhal. |
Intraspecies |
5 |
Default assessment factor for worker; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
100 mg/kg x 1 x 0.67 / (0.38 x 1 x 1 x 5 x 2.5 x 1 x 1) =14 mg/m³ |
Long term worker (systemic, dermal)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414/415; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for dermal absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
5 |
Default assessment factor for worker; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
100 mg/kg / (1 x 4 x 5 x 2.5 x 1 x 1) =2 mg/kg bw/d |
Long/short term exposure worker (local effects)
Sodium 2 -ethylhexanoate is in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 not classified for skin, eye or respiratory irritation. The performed tests for skin and eye irritation with the source substance 2 -ethylhexanoic acid (similar to OECD guideline 404 and 405) are indicating a slightly irritating potential. The 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 endpoint. In order to guarantee "adequately control of risks", it is necessary to stipulate risk management measures that prevent skin and eye exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Short term exposure consumer (systemic effects)
Same considerations as for the worker.
Long term exposure consumer (systemic effects)
The DNELs for oral, inhalation and dermal long term exposure are derived from the NOAEL (100 mg/kg bw) obtained in the oral reproductive and developmental toxicity studies with 2 -ethylhexanoic acid, the source substance of the read across approach (see chapter “toxicity for reproduction” and chapter 13 for read across justification).
Long term consumer (systemic, oral)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414/415; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for oral absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg / (1 x 4 x 10 x 2.5 x 1 x 1) =1 mg/kg bw/d |
Long term consumer (systemic, inhalation)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414/415; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1.15 |
Route to route (24h exposure) |
|
1/1 |
Absorption oral to inhal. (complete absorption after oral uptake according to toxicokinetic study) |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
1 |
No interspecies extrapolation for inhal. |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg x 1 / (1.15 x 1 x 1 x 10 x 2.5 x 1 x 1) =3.5 mg/m³ |
Long term consumer (systemic, dermal)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 100 mg/kg bw (OECD 414/415; oral; rat) |
The dose at which no adverse effects were observed in pups (developmental toxicity) |
Step 2) modification of the starting point |
1/1 |
No correction factor for dermal absorption according to pharmacokinetic study |
Step 3) Assessment factors |
|
|
Exposure duration |
1 |
No extrapolation of exposure duration since the NOAEL is from a reproductive toxicity study |
Interspecies |
4 |
Allometric scaling from rat to human |
Intraspecies |
10 |
Default assessment factor for consumer; as proposed in the REACh Guidance |
Remaining differences |
2.5 |
Default assessment factor as proposed in the REACh Guidance |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For consumer |
100 mg/kg / (1 x 4 x 10 x 2.5 x 1 x 1) =1 mg/kg bw/d |
Long/short term exposure consumer (local effects)
Same considerations as for the worker.
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.