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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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long-term toxicity to aquatic invertebrates
Type of information:
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Calculation meeting relevant validity criteria e.g. scientific validity of (Q)SAR model established and applicable for substance, adequate results for risk assessment and classification, and adequate documentation provided.
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Reason / purpose:
reference to same study

Data source

Reference Type:
other: QSAR
Report Date:

Materials and methods

Test guideline
according to
other: ECHA Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals
Principles of method if other than guideline:
QSAR is the use of a mathematical model relating the reported parameter to the chemical structure (molecular descriptors) to yield a quantitative measure of this property. The predicted quantitative extend of the modeled property takes into account molecular parameters of group of the same and of similar substances (and - if available - of similar functional groups).
GLP compliance:

Test material

Details on test material:
not reported

Sampling and analysis

Analytical monitoring:
not required

Test organisms

Test organisms (species):
Daphnia sp.
Details on test organisms:
not reported

Study design

Test type:
other: (Q)SAR
Water media type:
Limit test:
Post exposure observation period:
not required

Test conditions

Nominal and measured concentrations:
The results of the calculation are reported by the BIOWINTM in mmoles/L
Details on test conditions:
According to Annex IX "Standard Information Requirements for Substances Manufactured or Imported in Quantities of 100 Tonnes or More" of the "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC” (as amended) (OJ L 396, 30.12.2006, p 1), Section 9.1.5, the long-term toxicity testing on invertebrates (preferred species Daphnia), (unless already provided as part of Annex VII requirements) should be proposed for Registraion of substances manufactured or imported at => 100 t/a
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
21 d
Dose descriptor:
other: ChV =1/2 (NOEC + LOEC)
Effect conc.:
1 044 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
other: serveral effects
Remarks on result:
other: freshwater

Any other information on results incl. tables

ECHA clarifies that "REACH Annex XI foresees the use of (Q)SARs and grouping methods when testing does not appear necessary because the same level of information can be obtained by means other than (vertebrate) testing." Annex XI of the REACH regulation reads:

"Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property."


The calculation fulfills the following criteria of validity defined in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.6: QSARs and grouping of chemicals:

  • "results are derived from a (Q)SAR model whose scientific validity has been established": Model developed for and checked by EPA
  • "the substance falls within the applicability domain of the (Q)SAR model": organic substance with calculated result falling within data of test set
  • "results are adequate for the purpose of classification and labelling and/or risk assessment, and adequate and reliable documentation of the applied method is provided": Information is conclusive but does not indicate that the substance has to be classified in regard to the calculated parameter

Applicant's summary and conclusion

Validity criteria fulfilled:
Information is conclusive but does not indicate that the substance has to be classified in regard to the calculated parameter
Executive summary:

The Estimation Programs Interface (EPI) Suite v4.10 (January, 2011) (EPIWEB 4.1) of the US Environmental Protection Agency supplies adequate information for environmental classification and labeling and no experimental testing is required.