Registration Dossier
Registration Dossier
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EC number: 305-105-8 | CAS number: 94334-32-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thuya plicata, Cupressaceae.
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- 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, based on constituents approach of the UVCB substance.
There is no experimental study reference.
Data are compiled on 8 major components which represent about 91% of the UVCB.
Data source
Reference
- Reference Type:
- publication
- Title:
- ECOSAR v1.11
- Author:
- EPA United States Environnement Protection Agency
- Year:
- 2 012
- 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
- Guideline:
- other: ECOSAR
- Version / remarks:
- 1.11
- Principles of method if other than guideline:
- ECOSAR
Test material
- Reference substance name:
- Thuya plicata, ext.
- EC Number:
- 305-105-8
- EC Name:
- Thuya plicata, ext.
- Cas Number:
- 94334-32-4
- Molecular formula:
- not relevant as a UVCB substance
- IUPAC Name:
- Water steam distillation of needles and twigs of Thuya plicata
- Test material form:
- liquid
Constituent 1
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.03 mg/L
- Details on results:
- The toxicity to daphnia 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.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Based on a weight of evidence approach, the toxicity of assessed substance to daphnia during 48 hours can be estimated using adequate toxicity data of major constituents, greater than 1% in the mixture.
These 8 major constituents were considered, representing about 91% of the mixture.
These data are summarized in the above table.
The toxicity to daphnia 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 48 hours for UVCB substance is calculated at 1.03 mg/L for daphnia. - Executive summary:
With a LC50 daphnia value of 1.03 mg/l and some constituents (terpinene, myrcene, pinene, sabinene and limonene) with logKow > 4, the substance is classified H411 (cat 2) according to table 4.1.0 of regulation 1272/2008 (CLP).
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