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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

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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.