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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Persistence Assessment

4-tert-Octylphenol has been shown to be inherently biodegradable (28-day BODIS test) with 20% mineralisation during the 28-day study and in another case meets the criteria for ready biodegradability but failing the 10-day window (OECD 301B test) with 62% degradation after 28 days. A modified MITI test resulted in minimal degradation, although this study is considered to be less reliable and realistic than the ready biodegradability study. According to Regulation (EC) No 1907/2006 (REACH) ANNEX XIII and the Guidance on information requirements and chemical safety assessment, Chapter R.11 (PBT Assessment), the substance does not fulfill the screening criterion “persistent (P)” and “very persistent (vP)” as within the OECD 301B test the substance is shown to be degradable at a rate of more than 60% within 28 days.

4-tert-octylphenol is also biodegradable and unlikely to persist in freshwater sediments, marine sediments and soils, where these compartments are aerobic, although the substance may be considered to be persistent in anoxic sediments.

 

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), a substance does not fulfill the criterion “bioaccumulative (B)” or “very bioaccumulative (vB)” if the BCF is below 2000 or 5000 respectively or the log Kow is below 4.5.The reliablebioconcentration study for4-tert-octylphenol (Tsuda et al,2001)reported aBCF result of 261, based on whole body wet weight, forOryzias latipes. Supporting evidence from the read-across substance nonylphenol for juvenile fish reported BCF of 231 and 740 (whole body wet weight). A calculated BCFearthwormof 758 shows octylphenol is unlikely to accumulate through terrestrial food chains. In accordance with Annex XIII of Regulation (EC) No 1907/2006,4-tert-octylphenoldoes not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”asthe bioconcentration factor (BCF) issubstantiallybelow 2000 and 5000.No further testing is required to conclude on the bioaccumulation criterion.

Toxicity Assessment

A review of the toxicity test results for exposure of aquatic organisms resulted in reliable data from studies that included freshwater species and saltwater species representing fish, invertebrates, algae, and a snail. Short-term (acute) exposures of octylphenol to freshwater and marine invertebrates ranged from 0.019 to 0.11 mg octylphenol/L. The freshwater test organism (Gammarus pulex) may be more sensitive to effects on immobility and survival than the marine organism tested (Mysidopsis bahia). Fish species were generally found to be less sensitive to short-term octylphenol exposure than invertebrate organisms. Short-term survival LC50 values were >0.1 mg octylphenol/L for both fresh and saltwater test species. Other organisms tested included short-term octylphenol exposure to algae (Pseudokirchneriella subcapitataformerlySelenastrum capricornutum) and a mixed culture of microorganisms from activated sludge, both of which were markedly less sensitive to toxic effects of octylphenol than all other species tested.

 

Short-term acute toxicity (LC50 or EC50) to aquatic organisms is <0.1 mg/L but >0.01 mg/L and is considered to be toxic but does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). The most sensitive of three short-term reliable freshwater studies from three trophic levels (fish, invertebrate and algae) is the invertebrate,Gammarus pulex(Sims 1998) where the 96hr EC50 is 0.0133 mg/L. This study is based on the read-across substance nonylphenol. The substance is also known to exhibit oestrogen effects in some aquatic organisms. Avian chronic toxicity does not meet the T-criterion (< 30 mg/kg food) and nonylphenol is not considered to be toxic to birds within the PBT screening assessment. The most sensitive ecotoxicity data (0.0133 mg/L) for 4-tert-octylphenol in the aquatic environment is above the T criterion of 0.01 mg/L. There is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category 1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category 1, 2, or 3) according to Directive 67/548/ECC. Therefore, it can be concluded that the substance does not fulfill the toxicity (T) criterion as laid down in Annex XIII of regulation (EC) No 1907/2006 (amended March 2011 as No 253/2011).