Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

8. PBT AND VPVB ASSESSMENT

 

8.1. Assessment of PBT/vPvB Properties

8.1.1. Summary and overall conclusions on PBT or vPvB properties

 

Tripropylene glycol n-butyl ether highers does not have PBT or vPvB Properties.

8.1.2. PBT/vPvB criteria and justification

Persistence Assessment

Tripropylene glycol n-butyl ether highers is considered to be readily biodegradable based on a read across approach. Both tripropylene glycol n-butyl ether and SYNALOX* 100-50B have a similar chemical structure and bracket the molecular weight range for the test material. Since both of these materials are readily biodegradable, it can be concluded that tripropylene glycol butyl ether highers will also be readily biodegradable. Hence, the test substance does not fulfill the criteria for persistency as outlined in Annex XIII of the REACH legislation of December 2006.

Bioaccumulation Assessment

According to Annex XIII of Regulation (EC) No 1907/2006 and to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT Assessment, May 2008), a substance does not fulfill the criterion “bioaccumulative (B)” or “very bioaccumulative (vB)” if the BCF is below 2000 respectively 5000 or the log Kow is below 4.5.

Tripropylene glycol n-butyl ether has a low log Kow (log Kow < 4.5) and is readily biodegradable, which indicates that tripropylene glycol n-butyl ether highers offers little potential for bioconcentration in aquatic organisms. Therefore it does not fulfill the criteria for bioaccumulation as outlined in Annex XIII of REACH legislation of December 2006.

Toxicity Assessment

According to Annex XIII of Regulation (EC) No 1907/2006 and according to the Guidance on information requirements and chemical safety assessment Chapter 11 (PBT Assessment, May 2008), a substance does not fulfill the criterion if the NOEC for marine or freshwater organisms is higher than 0.01mg/l and if there is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/ECC.

Measured aquatic toxicity data indicate that tripropylene glycol n-butyl ether highers presents a low toxicity hazard to aquatic species. All EC50/LC50 values (fish, daphnia and algae) are greater than 100 mg/l.

Tripropylene glycol n-butyl ether highers is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008.

 

8.2. Emission Characterisation

 

Not applicable