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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction mass of 2,2'-[methylenebis(4,1- phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2- ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1- phenyleneoxymethylene)]dioxirane
Type of composition:
boundary composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence Assessment

A conclusion on persistence may be based available standard test data and, if needed, on performance of simple tests, such as the OECD TG 301 series (with or without enhancements as described in Sections R.7.9.4 and R.7.9.5. Based on the conditions of an OECD Guideline 301D "Ready Biodegradability: Closed Bottle Test" and three OECD 301B "Ready Biodegradability: CO2Evolution", the diglycidyl ether of bisphenol f (BPFDGE) was biodegraded a maximum of 16% after 28 days. Therefore, BPFDGE is not readily biodegradable under the conditions of the study and meets the P Criteria. If an OECD TG 301 study indicates <10% biodegradation and a simulation test indicates a half-life of over 200 days, this is normally sufficient to decide that the substance meets the P criteria and possibly the vP criteria. However, for substances for which persistency testing is difficult or practically impossible, like e.g. for certain multi-constituent or very poorly water soluble substances, it may sometimes be more reasonable to start the PBT/vPvB assessment by evaluating the B criterion. The B-assessment may in these cases start with non testing information such as log Kow data, molecular size, diameter and weight. In other cases, where it concerns multi-constituent substances or very poorly soluble substances, further specific bioaccumulation tests could form the start of the PBT or vPvB assessment. Guidance on the assessment of substances whose specific substance properties such as being a mixture of several constituents, formation of transformation products, low water solubility, high adsorption or volatility require derogation from the standard assessment and testing strategy is given in Section R.11.1.4 whereas the standard assessment approach is outlined in Section R.11.1.3.

Bioaccumulation Assessment

Information on accumulation in aquatic organisms is vital for understanding the environmental behaviour of a substance. Accumulation is a general term for the net result of absorption (uptake), distribution, metabolism and excretion (ADME) of a substance in an organism. For the PBT and vPvB assessment a screening criterion has been established, which is log Kow greater than 4.5. The assumption behind this is that the uptake of an organic substance is driven by its hydrophobicity. For organic substances with a log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg (based on wet weight of the organism, which refers to fish in most cases). BPFDGE has a calculated log Kow of 3.26. The QSAR model Bintein Fish Bioconcentration in the OECD Toolbox titled Non-Linear Dependence of Fish Bioconcentration on n-Octanol/Water Partition Coefficient was used to determine a Log BCF for BPFDGE. The model uses the equation Log BCF = 0.91 log Kow - 1.975 log(6.8E-7 Kow +1) - 0.786. BPFDGE has a BCF of 150 L/kg when generated from this model clearly below the B criteria of 2000 L/kg. BPFDGE is not B.

Toxicity Assessment

According to the REACH legislation (Annex XIII), a substance is considered to fulfill the toxicity criterion (T) when the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3), or there is evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

BPFDGE is not a CMR or classified as T, R48, or Xn, R48 according to Directive 67/548/EEC. To evaluate the chronic toxicity for BPFDGE a chronic daphnid test is available from the read across substance BADGE. The read across to BPFDGE from BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate for this endpoint as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology, that indicate similar characteristics. Survival, growth, and reproduction rate were all significantly reduced at 1 mg/L of BADGE, but were all unaffected at 0.3 mg/L. The long-term NOEC for aquatic organisms is greater than the 0.01 mg/L threshold.

Further, a substance is considered to potentially meet the criteria for T when an acute E(L)C50 value from a standard E(L)C50 toxicity test (REACH Annexes VII to X) is less than 0.1 mg/l. If the short-term aquatic toxicity, EC50 or LC50, is greater than 0.1 mg/L the substance is presumably not T. The acute toxicity of BPFDGE has been determined to be most sensitive to Selenastrum capricornutum. The acute toxicity of BPFDGE to S. capricornutum was determined in a 72 h sealed static toxicity test without renewal of the test media. Based upon the mean measured concentrations of BPFDGE in the test media over the duration of the test 72 h EC50 value has been calculated to be 1.8 mg/L.

Based on the chronic toxicity in Daphnia magna of 0.3 mg/L in the read across substance, BADGE, and the acute toxicity for the three tropic levels, the toxicity to planktonic alga Selenastrum capricornutum being the most sensitive with a 96 hr EC50 of 1.8 mg/L this toxicity is well above the value of 0.01 mg/L for T according to ECHA Guidance Chapter R.11. BPFDGE is not T.