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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Description of key information

The substance is with high probability acutely not harmful to aquatic invertebrates.

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.  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.

However, for the assessment of DMPDA CAS 7328-91-8 (Q)SAR results were used to assess the acute toxicity to aquatic invertebrates. 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 toxicity are not provided.

Assessment:

No experimental data on the short-term toxicity of DMPDA (CAS 7328-91-8) to aquatic invertebrates are available. In order to assess the short-term toxicity potential of DMPDA, EC50 values were calculated with the estimation model (Q)SAR Toolbox v4.1 using three valid profiling variations. The table below lists the applied profiling variation, the estimated EC50 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 6.1.1. The selected model complies with the OECD principles for (Q)SAR models.

 

Summary of calculated data on short-term toxicity to aquatic invertebrates: Predicted EC50 values for applied profiling variation; (Q)SAR Toolbox v4.1:

(AD = Applicability Domain)

(Q)SAR Toolbox v4.1

Calculation variant

INPUT PARAMETER:

Target profiles; primary grouping

INPUT PARAMETER:

Analogues selection; additional data pruning

EC50

[mg/L]

In AD

‚Standardized‘

Aquatic toxicity classification by ECOSAR:

“Aliphatic Amines”

- Data inconsistency filter

- Filter by water solubility

134

Yes

‚Standardized v1‘

Aquatic toxicity classification by ECOSAR:

“Aliphatic Amines”

- Data inconsistency filter

- Filter by water solubility

- Filter by test conditions

231

Yes

‚Standardized v2‘

Acute aquatic toxicity MOA by OASIS:

“Narcotic Amine”

- Data inconsistency filter

- Filter by water solubility

- Filter by test conditions

307

Yes

 

Conclusion:

Considering all profiling variations applied, the model (Q)SAR Toolbox v4.1 calculated for DMPDA (CAS 7328-91-8) 48-h EC50 values ranging from 134 to 307 mg/L; in all cases the substance was within the applicability domain of the estimation model. As a worst-case approach, the lowest value available (48-h EC50 = 134 mg/L) was selected as key value for the chemical safety assessment.

Based on a weight-of-evidence approach by the available estimated data, the substance is concluded to be with high probability not harmful to aquatic invertebrates.