Registration Dossier

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Classification based on calculation rules for mixtures of the CLP Regulation. There is no experimental study reference.
Data are compiled on 7 major components which represent more than 85% of the UVCB.

Data source

Reference
Reference Type:
publication
Title:
ECOSAR v1.11
Author:
EPA United States Environnement Protection Agency
Year:
2012
Bibliographic source:
https://www.epa.gov/tsca-screening-tools/ecological-structure-activity-relationships-ecosar-predictive-model

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: QSAR ECOSAR
Version / remarks:
V1.11
Principles of method if other than guideline:
ECOSAR version 1.11

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
ca. 2.436 mg/L
Remarks on result:
other:

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
Based on a weight of evidence approach, the toxicity of assessed substance to algae can be estimated using adequate toxicity data of major constituents, greater than 1% in the mixture.
Seven constituents were considered, representing more than 85% of the mixture.
These data are summarized in the above table.
The toxicity to algae were estimated using the following additivity formulas, as recommended in the Regulation (EC) No 1272/2008 (CLP) section 4.1.3.5.2:
∑ Ci / L(E)C50m = ∑ (Ci / L(E)C50i)
Where,Ci = concentration of component i (weight percentage);
L(E)C50i = LC50 or EC50 for component i, in mg/L; L(E)C50m = L(E)C50 of the part of the mixture with test data.
Based on data presented above, the EC50 value for UVCB substance is calculated at 2.44 mg/L for algae.
Executive summary:

With a EC50 algae value of 2.44 mg/l and some constituents (caryophyllene and lavandulyle acetate with logKow > 4), the substance is classified H411 (cat 2).