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EC number: 203-639-5
CAS number: 109-01-3
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 the substance (Q)SAR results 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.
Experimental data on the bioaccumulation of 1-methylpiperazine are not
available; therefore, the bioaccumulation potential of
1-methylpiperazine was assessed using read-across to an experimentally
determined BCF for the structurally similar substance piperazine (CAS
110-85-0) as well as using estimated BCF values using the valid and
well-established QSAR model Catalogic BCF base-line v4.11 (OASIS
Catalogic v18.104.22.168) for the substance itself and piperazine.
The bioaccumulation study for piperazine (CAS 110-85-0) was published by
NITE (1979). The GLP guideline study was conducted under flow-through
conditions using the test species Cyprinus carpio. The BCF was
determined for two test concentrations (0.01 and 0.1 mg/L). The maximum
BCF in the experiment was determined to be <= 3.9 L/kg.
This experimental result is supported with the estimation model: QSAR
BCF baseline v4.11 (OASIS CATALOGIC v22.214.171.124). 1-Methylpiperazin as
well as piperazine are completely within the applicability domain of the
model. The model can estimate the BCF for substances considering
mitigation factors like molecular size, water solubility, and
metabolism. The resulting BCF values for both substances were almost
identical: BCF = 3.0 L/kg. The maximum BCF, which does not consider any
mitigating factors, was 9.5 L/kg for 1-methylpiperazine and 9.3 L/kg for
piperazine. For both substances, water solubility had the highest impact
on the bioaccumulation potential, while metabolism and molecular size
reduce the BCF only to a minor part (BASF SE, 2020).
Based on the available experimental and estimated data, it can be
concluded that significant accumulation in organisms is not to be
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