Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

294-785-9

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference substance:

294-785-9

Reference 2

Name:

294-785-9

Type of composition:

boundary composition of the substance

Reference substance:

294-785-9

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence

 

Not P or vP

 

The test item may not be considered readily biodegradable under aerobic conditions since biodegradation ≥ 60% ThIC was not achieved within a 10-day window of reaching 10% ThIC. However, as a UVCB, the test item may be considered rapidly degradable since the pass level of 60 % of ThIC was achieved within 28 days (OECD 310).

Bioaccumulation

 

Not B or vB

 

Log Kow was determined using the HPLC method (OECD 117). The calculated log Kow as 11.7, far in excess of the cut off value of 10 which is cited in REACH guidance as a value suggesting that that BCF in aquatic organisms would be less than 2000 in a weight of evidence approach.

Certain components have a MW less than 550. Using EPIWIN for the lower molecular weight Bioaccumulation Estimates (BCFBAF v3.01). Log Kow used: 5.82 (estimated) equivalent MW 369.36:

Log BCF from regression-based method = 2.136 (BCF = 136.7 L/kg wet-wt)

Log Biotransformation Half-life (HL) = -0.4253 days (HL = 0.3755 days)

Log BCF Arnot-Gobas method (upper trophic) = 2.147 (BCF = 140.4)

Log BAF Arnot-Gobas method (upper trophic) = 2.150 (BAF = 141.1)

For the high molecular weight substance with a log Kow >11 uptake of this substance would be highly unlikely. Further evidence of very limited uptake stems from the long term daphnid and algae NOECs which are far greater than the solubility limit of the substance and the acute fish in which no effects were found (although due to the short duration this study is less pertinent to the evaluation). Furthermore, mammalian toxicity is also very low with no systemic effects beyond minor effects on liver weight which supports the argument that for the whole substance, levels of absorption are low and there is no indication that the toxic effects are increasing over time.

Toxicity

 

Not T

 

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (category 1A, 1B or 2). Furthermore, there is no evidence of chronic toxicity and the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2). With respect to the environment, the substance is not classified as environmentally hazardous when compared to criteria for rapidly degradable substances given in Regulation (EC) No. 1272/2008, and the chemical safety assessment raises no concerns. Specifically, the lowest NOELR value obtained during long-term testing of three trophic levels was 4.5 mg/L (algae) and this value is higher than the NOEC threshold of 0.01 mg/L given by ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017).

Likely routes of exposure:

Human: demal

Environment: waste water