Registration Dossier

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:
publication
Title:
Unnamed
Year:
2003
Report date:
2003
Reference Type:
secondary source
Title:
Unnamed
Year:
2009
Report date:
2009
Reference Type:
secondary source
Title:
Unnamed
Year:
2012
Report date:
2012
Reference Type:
secondary source
Title:
Unnamed
Year:
2015
Report date:
2015
Reference Type:
secondary source
Title:
Unnamed
Year:
2017
Report date:
2017
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation and on a weight of evidence approach.
The use of constituents appoach is within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.
So the acute toxicity oral of this UVCB substance can be estimated using adequate toxicity data of major constituents, greater than 1% or equal to 1% in the mixture.
9 constituents were considered, representing 84.5% of the mixture. 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 ; ATEi = Acute Toxicity Estimate of ingredient i.

Test material

Constituent 1
Reference substance name:
Thyme, Thymus mastichina, ext.
EC Number:
284-294-8
EC Name:
Thyme, Thymus mastichina, ext.
Cas Number:
84837-14-9
Molecular formula:
Not relevant for UVCB
IUPAC Name:
Thyme, Thymus mastichina, ext.
Test material form:
liquid: volatile

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
approximate LD50
Effect level:
ca. 2 346 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:
GHS criteria not met
Conclusions:
With a LD50 oral > 2000 mg/kg, the spanish marjoram oil is not classified according to CLP criteria and GHS criteria.