Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

Reference
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
PBT status:
the substance is not PBT / vPvB
Justification:

8. PBT AND VPVB ASSESSMENT

8.1. Assessment of PBT/vPvB Properties

8.1.1 Persistence Assessment

Diglyme is not readily biodegradable (OECD 302 B, see Section 5.2.1) but is rapidly degraded by OH radicals in the atmosphere (see Section 5.1 Endpoint summary). Based on the REACH Guidance R.16 the following half-lives were derived for Diglyme, compared with the REACH Annex XIII ‘P’ Criteria and the results were listed in the table 8.1.1 below. Table 40. Half-lives for Diglyme in various compartments & checking for Persistency

Compartment

Half-lives for Diglyme

REACH Annex XIII Half-life Criteria for being P (Persistent)

Persistency assigned for Diglyme

Freshwater

very high

> 40 d

Persistent

Marine water

very high

> 60 d

Persistent

Sediment

very high

> 120 d

Persistent

Soil

very high

> 120 d

Persistent

The 'P' criteria for Diglyme is fulfilled for all environmental compartments.

8.1.2 Bioaccumulation Assessment

Due to the low Log Kow of -0.36 for Diglyme the potential for bioaccumulation is very low (see IUCLID Chapter 4.7).

The 'B' criteria for Diglyme is NOT fulfilled as e.g. the Log octanol water partitioning coefficient is < 4.5 and therefore BCF <= 2000.

8.1.3 Toxicity Assessment

For the aquatic compartment Digylme the lowest ecotoxicity value is 320 mg/L (chronic NOEC (21d) Daphnia).

The 'T' criteria for Diglyme based on the lowest aquatic (chronic) toxicity result is NOT fulfilled as the toxicity value of 320 mg/L is above the chronic toxicity criteria of 0.01 mg/L for the aquatic compartment.

Diglyme is classified as reprotoxic category 2 and therefore the ‘T’ criteria related to Human health toxicity within the PBT &vPvB Assessment is fulfilled.

8.1.4 Summary and overall Conclusions on PBT or vPvB Properties

For Diglyme the ‘P’ and ‘T’ criteria are fulfilled but the ‘B’ criteria not. Nevertheless Diglyme is neither a 'PBT' nor a 'vPvB' substance.