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.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 3.1.3.6.2.3 of 1272/2008 regulation
- Principles of method if other than guideline:
- Based on a weight of evidence approach, the acute toxicity oral of this UVCB substance can be estimated using adequate toxicity data of major constituents, greater than 1% in the mixture.
8 constituents were considered, representing 91% of the mixture. But 4 constituents (representing 84% of the UVCB) have an available LD50 oral.These data are summarized in the table below.
The acute toxicity oral was estimated using the following additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP) part 3.1.3.6.2.3.:
100-(∑ Ci unkown if > 10 %) / ETA mix = ∑ (Ci / ETAi)Where,Ci = concentration of component i (weight percentage); i = the individual ingredient from 1 to n ; n = the number of ingredients ; ATE i = Acute Toxicity Estimate of ingredient i.
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 levels
- Sex:
- not specified
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 213 mg/kg bw
- Based on:
- other: calculation according to additivity formula of CLP regulation section 3.1.3.6.2.3.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- This essential oil is classified category 3 (H301) according to CLP criteria and GHS criteria in the worst case, considering the lowest LD50 oral find at 192 mg/kg bw.
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