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EC number: 203-430-9 | CAS number: 106-75-2
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Significant accumulation in organisms is not to be expected.
Key value for chemical safety assessment
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of oxydiethylene bis(chloroformate) (CAS 106 -75 -2, DIBIS) and its metabolite diethylene glycol (CAS 111-46 -6) (Q)SAR results and one experimental study (Freitag et al., 1985) were used for aquatic bioaccumulation.The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Therefore, and for reasons of animal welfare, further experimental studies on aquatic bioaccumulation are not provided.
Assessment
As oxidiethylene bischloroformate (DIBIS, CAS 106-75-2) rapidly hydrolyses in contact with water (see IUCLID Ch. 5.1.2), the analysis of the parent compound is of low relevance. . For reasons of comparison, the bioaccumulation potential was assessed for DIBIS as well as its hydrolysis product diethylene glycol (DEG, CAS 111 -46 -6). Although for hydrogen chloride and carbon dioxide no data on bioaccumulation are available, based on the expected low log Kow of these inorganic substances bioaccumulation is considered to be unlikely.
In accordance with column 2 of REACH Annex IX, the study does not need to be conducted as the substances can be expected to have a low potential for bioaccumulation based on their low octanol water partition coefficients (log Kow ≤ 3). DIBIS has a log Kow of -0.34 (estimated; see IUCLID Ch. 4.7). Its hydrolysis product DEG (CAS 111 -46 -6) -1.98 (experimental; see IUCLID Ch.4.7).
In case of DEG (CAS 111-46-6), an experimentally determined BCF is available. Freitag et al. (1985) exposed fish (L. idus) to one concentration level (0.05 mg/L) of radiolabelled DEG for three days. The BCF was measured to be 100 L/kg.
The low potential for bioaccumulation is supported by estimated BCF data for DEG.
The bioaccumulation potential of the oxidiethylene bischloroformate was assessed by calculating the BCF with BCFBAF v3.01, EPI Suite v4.11 (BASF SE, 2018). Considering all three submodels the BCF values ranges from 0.9 to 3.2. The Arnot-Gobas submodel (steady-state BCF, Arnot-Gobas 2003) estimated a BCF of 0.90 incl. biotransformation and without biotransformation of 0.94 for the upper trophic level. According to Meylan, the BCF is 3.2 based on the estimated log Kow of -0.34 (Meylan et al., 1997/1999). The substance is within the applicability domain (AD) of both submodels, but not in the AD of the biotransformation model of Arnot et al. (2008/09). Based on the available information (log Kow and estimated BCF values), it can be concluded that significant accumulation in organisms of DIBIS would not be expected.
In order to assess the bioaccumulation potential of the hydrolysis product diethylene glycol (DEG), the BCF was calculated with BCFBAF v3.01, EPI Suite v4.11 (BASF SE, 2015). Considering all three submodels the BCF values ranges from 0.89 to 3.2. The steady-state BCF model of Arnot & Gobas (2003) calculated a BCF of 0.89 with or without considering. biotransformation for the upper trophic level. The regression-based model of Meylan et al. (1997/1999) calculated a BCF of 3.2. The substance is within the applicability domain (AD) of the BCFBAF submodel: BAF and steady-state BCF Arnot & Gobas, 2003), but not in the AD of the biotransformation model of Arnot et al. (2008/09).
Based on the available information (log Kow, experimental and estimated BCF values), it can be concluded that significant accumulation in organisms is not to be expected.
This conclusion is in agreement with the OECD SIDS (2004) as well as the CoRAP report (ECHA 2016) for diethylene glycol (CAS 111 -46 -6).
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