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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 629-721-4 | CAS number: 308062-60-4
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.879 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.177 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.088 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 24.6 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 2.46 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 1.22 mg/kg soil dw
- Assessment factor:
- 1
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 1.11 mg/kg food
- Assessment factor:
- 900
Additional information
All aquatic endpoints are based on measured data applying assessment factors. For soil and sediment PNEC is calculated using the equilibrium partition coefficient method.
The PNEC oral is based on the LOAEL from the 28-day repeated dose study with rats (age 7wk). A food conversion factor of 20 is used. The assessment factor for a 28-day study (300) is multiplied with 3, since the result is a LOAEL.
As for the aquatic tests the measured dissolved concentration was used for the derivation of the dose effect assessment, the results should be compared to the dissolved exposure concentrations.
The PNECaquatic is calculated using the assessment factor proposed by the TGD. As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. Fish are in general not more sensitive compared to daphnia and algae and no effects were observed to daphnia at the water accommodated fraction concentration of 48.3 µg/L. As the algae EC10 is 8.79 µg/L it is very unlikely that a long-term fish study will result in a lower EC10. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the dialkylamines C16 -18other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare. This means that it is proposed to waive the long term fish unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment.
Based on the before mentioned facts it is considered acceptable for dialkyl amine C16 -18 to apply a safety factor of 10 for the derivation of the PNECaquatic.
Conclusion on classification
Environment
For classification purposes Ecotoxicity, Biodegradability and Bioconcentration have to be considered
Ecotoxicity
Table 1 Available aquatic toxicity data for the dialkylamines.
Dialkylamines |
CAS number |
96 h Fish LC50 (µg/L) |
72 h algae ERC50(µg/L) |
72 h algae ERC10/ NOEC (µg/L) |
48 h daphnia EC50 (µg/L) |
Amines, di-C16-18 (evennumbered) alkyl |
308062-60-4 |
(220000) |
17.7 |
8.8 |
>48.3 |
Figures given in bold are based on read across; figures given in italic and underlined are performed in reconstituted lab water. The values in parenthesis in grey are from Klimisch 3 studies.
Table 2 Environmental classification for the dialkylamines.
Substance |
CAS number |
Classification |
M factor, chronic |
M factor, acute |
Amines, di-C16-18 (evennumbered) alkyl |
308062-60-4 |
Acute Cat1 Chronic Cat1 |
1 |
10 |
Although the studies used as a basis for classification are performed in natural river water, no mitigating factor is applied to the results, since in the study the solubility of the substance is low, and the test was performed as the water accommodated fraction after filtering of the water to remove suspended particles.
Biodegradability
For the poorly soluble dialkylamines ready biodegradability test results in excess of 60% at day 28 are available for the short (C12) and long (C18) chain. Biodegradation in excess of 60% was not achieved in a few tests. The low biodegradability test results in these tests should be attributed to the limited bioavailability under the stringent test conditions and should consequently be ignored.
Table 3 Compilation of ready biodegradability test results obtained with dialkyl amines
Test substance name |
Test Guideline |
Result at day 28 (%) |
Source |
Didodecylamine |
OECD 301D |
>70 |
Ginkel et al., 1994 |
Amines, di-C12-18-alkyl |
OECD 301D |
20 |
Ginkel 1992 |
Amines, di-C12-18-alkyl |
DIN 38409/ OECD 301C |
25 |
Voelskow, 1990 |
Amines, di-C16-18 (evennumbered) C18 unsaturated alkyl |
OECD 301D |
4 |
Ginkel 1993 |
Amines, di-C16-18 (evennumbered) alkyl |
OECD 301F |
16 |
Voelskow 1996 |
Dioctadecylamine |
OECD 301D |
79 |
Ginkel, C.G., 2005 |
Dioctadecylamine |
OECD 301D |
68 |
Ginkel, C.G., 2005 |
Bioaccumulation potential
No measured BCF fish is available for the dialkylamines. Standard OECD 305 tests are technically very complicated with these strongly adsorbing, poorly soluble and readily biodegradable substances. No measured log Kow value is available and therefore the log Kow and BCF were calculated using EPIsuite v4.0 as presented in the table below.
Table 4 Estimated Log Kow and BCF
Dialkylamines |
CAS number |
Estimated Log Kow (KOWWIN v1.67) |
Estimated BCF
|
Amines, di-C16-18 (evennumbered) alkyl |
308062-60-4 |
16.52 |
0.893 |
All dialkylamines have log Kow values above the log Kow threshold for DSD or CLP. It is however important to note that linear QSAR relationships between log Kow and BCF are only valid for logKow<6. Above this value, these predictions will become increasingly inaccurate. This is probably due to the limited availability of the chemical as well as the increasing difficulty in crossing membranes (Opperhuizen et al, 1985, Anliker et al, 1988).The influence of the limited bioavailability is included in the calculation of the BCF with the BCFBAF v3.00. The calculated BCF results therefore most likely represent the partitioning behavior more realistically than based on the log Kow. This means the substance should be classified as R-50.
References:
1. Anliker R, Moser P and Poppinger D, 1988. Bioaccumulation of dyestuffs and organic pigments in fish. Relationships to hydrophobicity and steric factors. Chemosphere, 17, 1631 - 1644.
2. Opperhuizen A, vd Velde EW, Gobas FAPC, Liem DAK and v d Steen JMD, 1985.Relationship between bioconcentration in fish and steric factors of hydrophobic chemicals. Chemosphere, 14, 1871 - 1896.
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.