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EC number: 479-940-2 | CAS number: 613246-75-6
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Name:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- Reference substance:
- Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10- dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene- 1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Conclusion on Persistance: not vP and not P
Sika Härter LJ was assessed to be not readily biodegradable but is considered to be inherently biodegradable. The degree of biodegradation reached 30% after 28 days. The 10 d-window began on day 5 and 25% were reached at its end, staying below the pass level of 60% given in the OECD guideline. In addition, Sika Härter LJ belongs to a class of polyaldimine compounds used as hardeners for polyurethane moisture hardening preparations. It was demonstrated that the substance rapidly, i.e. within seconds to minutes, hydrolytically degrades to Polyetheramin D230 (CAS No. 9046-10-0) and 2,2-Dimethyl-3-lauroyloxy-propanal (CAS No. 102985-93-3). The hydrolysis product, 2,2-Dimethyl-3-lauroyloxy-propanal, has been proven to be readily biodegradable and rapidly degraded by hydrolysis (please refer to section 5.1.2 and 5.2.1). Data on biotic and abiotic degradation of Polyetheramin D230 (CAS No. 9046-10-0) are not available. In conclusion, Sika Härter LJ is regarded not P (and vP).
Conclusion on Bioaccumulation: not vB and not B
In accordance with column 2 in REACH Annex VII, the experimental determination of the partition coefficient is technically not feasible due to rapid hydrolysis of Sika Härter LJ upon contact with water. As a worst case assumption the highest log Pow value of 13.6742 is used as key value for chemical safety assessment, which is above the trigger value for the B criterion of log Pow > 4.5 as indicated in the ECHA Guidance on PBT/vPvB assessment (version 3.0, June 2017).
However, in the same guidance it is stated that "a substance is unlikely to meet the B criterion (i.e. unlikely to have a BCF > 2,000) if some or all of the following indicators are met:
1. an average maximum diameter (Dmaxaver) of greater than 1.7 nm
2. octanol-water partition coefficient as Log10 (Log Kow) > 10 (calculated value, preferably by several estimation programs, for substances for which Log Kow can be calculated and the model is reliable)
3. a measured octanol solubility (mg/L) < 0.002 mmol/L× MW (g/mol) (without observed toxicity or other indicators of bioaccumulation)"
Sika Härter LJ is considered to be sterically hindered as its molecules’ average maximum diameter is greater than 1.7 nm. Further, the log Pow considered for risk assessment is clearly above the trigger value of Log Kow > 10. Further, both hydrolysis products are of no concern for bioaccumulation. The log Pow of the hydrolysis product Polyetheramin D230 is below the trigger value of 4.5 for bioaccumulation potential as indicated in the ECHA Guidance on PBT/vPvB assessment. The other hydrolysis product, 2,2-Dimethyl-3-lauroyloxy-propanal, has been proven to be readily biodegradable and rapidly degraded by hydrolysis (please refer to section 5.1.2 and 5.2.1).
In sum, no potential for bioaccumulation is expected for Sika Härter LJ and its hydrolysis products. Thus, the substance is not considered to be very bioaccumulative (vB) or bioaccumulative (B).
Conclusion on Toxicity: not T
The criterion for toxicity is not fulfilled, since Sika Härter LJ was tested for toxicity to aquatic freshwater algae in 72 h growth inhibition test according to OECD guideline 201 revealing an EC50 of > 460 mg/L and a NOEC of 18 mg/L; and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to directive 67/548, or carcinogenic, germ cell mutagenic or toxic for reproduction according to Regulation EC No 1272/2008; and there is no evidence of chronic toxicity or specific target organ toxicity after repeated exposure according to Regulation 1272/2008 as amended for the fifteenth time in Regulation (EU) 2020/1182. .
Overall conclusion on PBT and vPvB
Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.
Referenceopen allclose all
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