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Diss Factsheets
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EC number: 270-296-6 | CAS number: 68424-35-1
- 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:
- 22.04 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 43
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
Acute toxicity
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (e.g. C&L) has been identified and there is a potential for high peak exposures. These “peaks” are normally associated with inhalation exposure but are less common for skin contact and ingestion (Appendix R.8-8). Neodecanoic acid is not classified for acute toxicity; oral, dermal or inhalation.
Irritation
Neodecanoic acid is not classified as a skin irritant. A DNEL is not required for this endpoint.
Sensitization
Neodecanoic acid is not classified as a sensitizer. A DNEL is not required for this endpoint.
Genetic toxicity
Neodecanoic acid is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint.
Reproductive and Developmental toxicity
Neodecanoic acid is not classified as a reproductive or developmental toxin. A DNEL is not required for this endpoint.
Long-term systemic effects
The potential of a substance to cause long-term systemic effects can judged based on the results of repeated dose toxicity testing. The following DNELs are conservative by nature and are protective of all adverse effects.
Dermal - Systemic
Dose descriptor = NOAEL of 400 mg/kg/day; from a well described repeated dose dermal study.
Modification of dose descriptor
= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days)
= 400 * (8 / 8) * (4 / 5)
dermal NOAEL = 320 mg/kg/day
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rabbit |
2.4 |
Intraspecies - workers |
3 |
Subacute study to Chronic |
6 |
Overall Adjustment Factor |
43.2 |
DNEL calculation
DNEL dermal = dermal NOAEL / (adjustment factors)
DNEL dermal = 320 mg/kg/day / (2.4 * 3 * 6)
DNEL dermal = 7.41 mg/kg/day
Inhalation
Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development study
Route-to-route extrapolation (calculation B.3 in ECHA Guidance R.8)
inhalatory NOAEC = oral LOAEL * (1/ sRV rat 8h) * (ABS oral / ABS inh) * (sRV human / wRV)
inhalatory NOAEC= 75 * (1/0.38) * (100/100) * (6.7 / 10)
inhalatory NOAEC = 132.24 mg/m3
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
not applied |
Intraspecies - workers |
3 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
6 |
DNEL calculation
DNEL inhalation = inhalation NOAEC / (adjustment factors)
DNEL inhalation = 132.24 mg/m3 / (6)
DNEL inhalation = 22.04 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.52 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.06 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.88 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute toxicity
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (e.g. C&L) has been identified and there is a potential for high peak exposures. These “peaks” are normally associated with inhalation exposure but are less common for skin contact and ingestion (Appendix R.8-8). Neodecanoic acid is not classified for acute toxicity; oral, dermal or inhalation.
Irritation
Neodecanoic acid is not classified as a skin irritant. A DNEL is not required for this endpoint.
Sensitization
Neodecanoic acid is not classified as a sensitizer. A DNEL is not required for this endpoint.
Genetic toxicity
Neodecanoic acid is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint.
Reproductive and Developmental toxicity
Neodecanoic acid is not classified as a reproductive or developmental toxin. A DNEL is not required for this endpoint.
Long-term systemic effects
The potential of a substance to cause long-term systemic effects can judged based on the results of repeated dose toxicity testing. The following DNELs are conservative by nature and are protective of all adverse effects.
Dermal - Systemic
Dose descriptor = NOAEL of 400 mg/kg/day; from a well described repeated dose dermal study.
Modification of dose descriptor
= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days)
= 400 * (8 / 24) * (4 / 7)
dermal NOAEL = 76.19 mg/kg/day
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rabbit |
2.4 |
Intraspecies – general population |
5 |
Subacute study to Chronic |
6 |
Overall Adjustment Factor |
72 |
DNEL calculation
DNEL dermal = dermal NOAEL / (adjustment factors)
DNEL dermal = 76.19 mg/kg/day / (2.4 * 5 * 6)
DNEL dermal = 1.06 mg/kg/day
Inhalation
Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development study
Route-to-route extrapolation (calculation B.3 in ECHA Guidance R.8)
inhalatory NOAEC = oral NOAEL * (1/ sRV rat 24h) * (ABS oral / ABS inh)
inhalatory NOAEC= 75 * (1/1.15) * (100/100)
inhalatory NOAEC = 65.22 mg/m3
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
not applied |
Intraspecies – General Population |
5 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
10 |
DNEL calculation
DNEL inhalation = inhalation NOAEC / (adjustment factors)
DNEL inhalation = 65.22 mg/m3 / (10)
DNEL inhalation = 6.52 mg/m3
Oral
Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development study
Modification of dose descriptor: Not required
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
4 |
Intraspecies – General Population |
5 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
40 |
DNEL calculation
DNEL oral = oral NOAEL / (adjustment factors)
DNEL oral = 75 mg/kg/day / (40)
DNEL oral = 1.88 mg/kg/day
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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