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EC number: 201-162-7
CAS number: 78-96-6
Significant accumulation in organisms is not to be expected.
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 MIPA (Q)SAR results were used for
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 bioaccumulationare not provided.
According to Regulation (EC) 1907/2006 Annex IX, Section 9.3.2, Column
2, the study does not need to be conducted since the substance has a log
Kow less or equal than 3. MIPA (CAS 78-96-6) has a log Kow of -0.93 at
23 °C (BASF AG, 1987, report no. BRU 87.262, see IUCLID Ch. 4.7).
Therefore, and for reasons of animal welfare, an experimental study on
bioaccumulation is not provided.
However, in order to assess the bioaccumulation potential of the test
substance, the BCF was calculated with QSAR estimation models. The table
below lists the applied (Q)SAR models, the estimated BCF values and
basic information on the applicability domain (AD). Detailed information
on the model’s results and the AD are given in the endpoint study
records of IUCLID Chapter 5.3.1. The selected models comply with the
OECD principles for (Q)SAR models.
Summary of relevant information on aquatic bioaccumulation: Predicted
BCF values for applied QSAR models sorted by BCF (AD = Applicability
BCF baseline model v04.11 (OASIS Catalogic v5.14.1)
Considering all mitigating factors.
Not considering any mitigating factors.
BCFBAF v3.01 (EPISuite v4.11): Arnot-Gobas BCF, upper trophic, incl. biotransformation estimates
As the substance ionizes at physiologically relevant pH, the estimation may be less accurate.
BCFBAF v3.01 (EPISuite v4.11): Arnot-Gobas BCF, upper trophic, incl. biotransformation of zero
BCFBAF v3.01 (EPISuite v4.11): Meylan et al. (1997/1999)
Considering the applied models the estimated BCF values range from 0.9
to 9.3 L/kg. Based on the available information on the log Kow (log Kow
= -0.93; measured; BASF AG, report no. BRU 87.262, 1987) and supported
by these QSAR results, it can be concluded that significant accumulation
in organisms is not to be expected.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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