Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2011
Reliability:
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
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
other: QSAR
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ECHA Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals
Deviations:
yes
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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not reported

Sampling and analysis

Analytical monitoring:
not required

Test organisms

Test organisms (species):
other: earthworm (not otherwise specified)
Animal group:
annelids

Study design

Study type:
other: (Q)SAR
Substrate type:
not specified
Limit test:
no
Total exposure duration:
14 d

Test conditions

Details on test conditions:
According to the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.6: QSARs and grouping of chemicals, a QSAR calculation is valid as long as:
• "results are derived from a (Q)SAR model whose scientific validity has been established
• the substance falls within the applicability domain of the (Q)SAR model,
• 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."
Reference substance (positive control):
not specified
Remarks:
not required

Results and discussion

Effect concentrations
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
8 648 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
substance
Basis for effect:
mortality

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:
yes
Conclusions:
Not toxic to soil organisms