acetalization product between glucose and C20-22(even numbered)- alcohol

Endpoint summary

Additional information

According to an OECD test n°203: LC50 -96h fish > 100 mg/l

According to OECD test n°202, EC50 -48h > 100 mg/l

According to OECD test n°201, ErC50 -72h > 100 mg/l, NOEC 72h growth rate = 100 mg/l

According to OECD test n°211, NOELR 21 d - reproduction = 100 mg/l

The three acute aquatic toxicity tests available and the chronic aquatic test on daphnia did not permit to determine a more sensitive species, furthermore, it is written in the REACH guidance Chapter R.7b (Endpoint specific guidance Version 3.0 – February 2016), Table R.7.8—3, "No Observable Effect Loading Rate (NOELR) values from chronic tests may be sufficiently low to be of the same order as the level at which most components are dissolved (or the PEC value), in which case they can be used for PNEC derivation";

So it could not be relevant to do the chemical safety assessment based on the NOELR from the chronic aquatic test on daphnia as this value (100 mg/l) is not in the same order as the water solubility (1 mg/l).

For these reasons, a chronic aquatic test on fish was performed.

According to OECD test n°210, the No Observed Loading Rate (NOELR) 33d for survival and growth was 100 mg/L loading rate WAF. 

Acute toxicity tests on « Acetalization product between glucose and C20/22 (even numbered) alcohol” were performed and gave L(E)C50 > 100 mg/l (3 trophic levels). These results provide supporting data, due to the low water solubility of the substance.

Two aquatic chronic studies were performed. A study was performed to assess the chronic toxicity of the test item to Daphnia magna according to OECD Guidelines for Testing of Chemicals (2012) No 211. The "No Observed Effect Loading Rate" was considered to be 100 mg/L on the basis that at this test concentration there was no significant mortality (immobilization) observed in the parental generation (P1) and that there were no significant differences between the control and the 100 mg/L loading rate WAF test group in terms of numbers of live young produced per adult by Day 21. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L.

Another study was conducted to evaluate the chronic toxicity of the test item to fishes according to OECD guideline n°210.

The application of the test item to newly laid eggs of fathead minnows was considered to have no effect on the survival or growth of the larvae. The No Observed Loading Rate was 100 mg/L loading rate WAF. 

Furthermore, published data on alcohols (1) showed that no effect up to limit of water solubility for single chain lengths >C14 was noted for acute tests on fish, invertebrate and algae. For the longest chain category members (>C16), the low solubility limits the dissolved (and hence bioavailable) concentration of the alcohol to the extent that no acute nor chronic toxicity is likely to be exhibited. C20-22 alcohols represent 85% of the UVCB.

The aquatic compartment do not seem to be very relevant based on the log koc value and the very low water solubility expected (around 1 µg/l - see section 4.8).

Indeed, Log koc value of « Acetalization product between glucose and C20/22 (even numbered) alcohol” was determined to be between 4.49 and 5.05 (OECD 106) depending on the soils tested. Desorption was lower than adsorption in all the test soils indicating easy and strong adsorption and low desorption. The registered substance will be mainly located in soil and sediment compartments.

A chronic test on earthworms (OECD 222 - see section 6.3.1) did not show inhibitory effect on the reproduction of earthworms at the highest dose tested of 1000 mg/kg dw.

On the other hand, “Acetalization product between glucose and C20/22 (even numbered) alcohol” was considered readily biodegradable.

(1) SIDS Initial Assessment Report For SIAM 22 (18 – 21 April 2006) - TOME 1: SIAR; Category Name “Long Chain Alcohols” (C6-22 primary aliphatic alcohols)