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Administrative data

Description of key information

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 10% in the mixture. Three constituents were considered, representing 72% of the mixture.

The acute toxicity oral was estimated using the following additivity formula, as recommended in the section 3.1.3.6.2.3 of the Regulation (EC) No 1272/2008 (CLP) :

100 -(∑ C unknown if > 10%) / ATE mix = ∑ (Ci / ATE i)

Where,Ci = concentration of component i (weight percentage);

i = the individual ingredient from 1 to n ;

n = the number of ingredient

ATE i = acute toxicity estimate of ingredient i

ATE mix = acute toxicity estimate of mixture

DL50 oral of the thuya occidentalis oil is estimated at 229 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data comes from an online compilation using secondary data sources.
No study was conducted on the oil iself, as not relevant for an UVCB. Literature provided data for the 2 major components representing 72%. Fenchone content of the UVCB is about 12% (typical value).
Qualifier:
according to
Guideline:
other: source NLM, 1997b ; Opdyke, 1976
Principles of method if other than guideline:
source NLM, 1997b ; Opdyke, 1976
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 160 mg/kg bw
Based on:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Fenchone represented at a level of 12% in the thuya occidentalis oil has a LD50 oral rats at 6160 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data comes from an online compilation using secondary data sources. There is no experimental study reference, however data is cited in the database as peer reviewed.
No study was conducted on the oil iself, as not relevant for an UVCB. Literature provided data for the 2 major components representing 72%. Thujones content of the UVCB is about 60%.
Qualifier:
according to
Guideline:
other: Margaria R. (1963) Acute and sub-acute toxicity study on thujone. Unpublished report of the Instituto de Fisiologia, Universita di Milano (cited from the CoE Datasheet RD 4.2/14-44, 1999)
Principles of method if other than guideline:
source : Margaria R. (1963) Acute and sub-acute toxicity study on thujone. Unpublished report of the Instituto de Fisiologia, Universita di Milano (cited from the CoE Datasheet RD 4.2/14-44, 1999)
GLP compliance:
not specified
Specific details on test material used for the study:
mixture from α- and β-thujone
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
192 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The alpha, beta thuyone represented at a level of 60% in the thuya occidentalis oil has a LD50 oral rats at 192 mg/kg bw (worst case) so classified H301 in CLP and GHS system.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
229 mg/kg bw

Additional information

Justification for classification or non-classification