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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-610-1 | CAS number: 68131-13-5
- 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 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):
- 40
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NA-DETA is likely to be readily bioavailable both for oral and inhalation routes. Based on the molecular mass and liphophilicity of major components of NA-DETA, it can be predicted that most of the inhalated Na-DETA will be deposited in the upper respiratory tract, resulting into the resorption in the gastro-intestinal tract. Comparable resorption for oral and inhalation routes assumed; Human body weight of 70 kg/person; Daily respiration volume for a worker of 10 m3.
- AF for dose response relationship:
- 1
- Justification:
- Clear dose responce relation was demontrated; no effect was demonstrated at 100 mg/kg bw in OECD 422 study and at 6 mg/kg bw in subchronic toxicity study.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic data to chronic exposure situation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats were used in the proposed repeated dose toxicity studies
- AF for other interspecies differences:
- 1
- Justification:
- The remaining factor is not justified; the target organ is liver and the metabolic overload as mode of action is apparent. Any species difference due to the different toxicodynamic profile is not likely.
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The available data to generate the DNEL for NA-DETA does not cover the endpoint developmental toxicity. An OECD 414 study is proposed to fill the data gap. The provided DNEL is based on the repeated dose toxicity of naphthenic acid and should be revised in case that adverse effect occur in the planned OECD 414 study in the dose range of 10 mg/kg bw. All other endpoints are covered either by experimental data on NA-DETA or by read-across.
- AF for remaining uncertainties:
- 1
- Justification:
- The toxicity variation of naphthenic acids of different sources (commercial vs. oil sands tailings) is considered to be the most critical point related to the hazard assessment of NA-DETA. Since NA-DETA is the reaction mass of the commercial naphthenic acid, the data on commercial naphthenic acid is likely to be more relevant for the NA-DETA. However, in absence of convincing data explaining the toxicity variations, the possible relation of NA-DETA to naphthenic acids of oil sands tailings cannot be rejected. For the derivation of the DNEL for NA-DETA, it is proposed to use the NOAEL of 6 mg/kg bw from subchronic toxicity study on naphthenic acid from oil sands tailings (instead of the NOAEL of 100 mg/kg bw from the OECD 422 study on the commercial naphthenic acid) to cover the uncertainties related to the toxicity variation of naphthenic acids. It is likely that the toxicity of NA-DETA is overestimated and the related risk as well. Such approach is sufficiently conservative to cover the possible potency difference of target and source substances.Further assessment factors related to the read-across uncertainty is considered to be not necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and dermal routes assumed
- AF for dose response relationship:
- 1
- Justification:
- Clear dose responce relation was demontrated; no effect was demonstrated at 100 mg/kg bw in OECD 422 study and at 6 mg/kg bw in subchronic toxicity study.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic data to chronic exposure situation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats were used in the proposed repeated dose toxicity studies
- AF for other interspecies differences:
- 1
- Justification:
- The remaining factor is not justified; the target organ is liver and the metabolic overload as mode of action is apparent. Any species difference due to the different toxicodynamic profile is not likely.
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The available data to generate the DNEL for NA-DETA does not cover the endpoint developmental toxicity. An OECD 414 study is proposed to fill the data gap. The provided DNEL is based on the repeated dose toxicity of naphthenic acid and should be revised in case that adverse effect occur in the planned OECD 414 study in the dose range of 10 mg/kg bw. All other endpoints are covered either by experimental data on NA-DETA or by read-across.
- AF for remaining uncertainties:
- 1
- Justification:
- The toxicity variation of naphthenic acids of different sources (commercial vs. oil sands tailings) is considered to be the most critical point related to the hazard assessment of NA-DETA. Since NA-DETA is the reaction mass of the commercial naphthenic acid, the data on commercial naphthenic acid is likely to be more relevant for the NA-DETA. However, in absence of convincing data explaining the toxicity variations, the possible relation of NA-DETA to naphthenic acids of oil sands tailings cannot be rejected. For the derivation of the DNEL for NA-DETA, it is proposed to use the NOAEL of 6 mg/kg bw from subchronic toxicity study on naphthenic acid from oil sands tailings (instead of the NOAEL of 100 mg/kg bw from the OECD 422 study on the commercial naphthenic acid) to cover the uncertainties related to the toxicity variation of naphthenic acids. It is likely that the toxicity of NA-DETA is overestimated and the related risk as well. Such approach is sufficiently conservative to cover the possible potency difference of target and source substances.Further assessment factors related to the read-across uncertainty is considered to be not necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/cm²
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/cm²
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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.