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Diss Factsheets

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:
2015
Report date:
2015
Reference Type:
secondary source
Title:
Unnamed
Year:
2009
Report date:
2009
Reference Type:
publication
Title:
Unnamed
Year:
2011
Report date:
2011
Reference Type:
publication
Title:
Unnamed
Year:
1999
Report date:
1999
Reference Type:
secondary source
Title:
Unnamed
Year:
2012
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

Constituent 1
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:
Thuya plicata, ext.
Test material form:
liquid

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.