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Diss Factsheets

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 1% in the mixture.

9 constituents were considered, representing 80% of the UVCB. These data are summarized in the table below.  

Consistuent

%

 Acute tox oral DL50 oral (mg/kg=ppm) Ci/ETAi Animals
Camphor 27,68 1310 0,02112977 mice
Cineol 23,77 2480 0,00958468 rats
Camphene 7,08 5000 0,001416 rats
Alpha pinene 5,56 3700 0,0015027 rats
Limonene 4,53 5600 0,00080893 mice
Beta pinene 4,41 4700 0,0009383 rats
Myrcene  2,77 5000 0,000554 rats
Linalyl acetate 2,56 2864 0,00089385 rats
Linalol 1,59 2790 0,00056989 rats
somme 79,95 somme 0,03739812  
                                                                                                       

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.  

ETA mix = 2137.8 mg/kg

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:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
The flavor and Fragance High Production Volume Consortia; Revised Robust Summaries for Bictclic Terpene Hydrocarbons Submitted to EPA under the HPV Challange Programm. p. 140 (Novembre9,20016) Available from, as of October 8, 2008
GLP compliance:
not specified
Details on oral exposure:
Ten male Wistar. The DL50 calculated from data was 3700 mg/kg bw (95% C.L. 2300-5100 mg/kg bw)
Sex:
male
Dose descriptor:
LD50
Effect level:
3 700 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 3700 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials.11th Edition. Wiley-Interscience, Wiley & Sons, Unc. Hoboken, NJ.2004., p.3099.
GLP compliance:
not specified
Details on oral exposure:
The animals are rats.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 4 700 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 4700 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Unkonwn
GLP compliance:
not specified
Details on oral exposure:
Bingham, E.; Cohrssen, Bn; Powell, C.H., Patty's Toxicology Volume 1-9 5th ed. John iley & Sons. New York, N.Y. (2001).,p. V4 218
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 5000 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Opdyke 1978
Details on oral exposure:
The animals are mice.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 310 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 value in mice was reported 1310 mg/kg. The substance is classified category 4 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
european Chemicals Agency (ECHA); Registered substances, Cineol (CAS Numer 470-82-6) (EC Numer : 207-431-5) (Last modified ; January 19, 2015). Available from, as of June 22,2015
GLP compliance:
not specified
Details on oral exposure:
The animals are rats.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 2 480 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 2480 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Unkonwn
GLP compliance:
not specified
Details on oral exposure:
The LD50 values d-limonene in male and female mince were reported to be 5.6 and 6.6 (oral) g/kg
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 600 mg/kg bw
Based on:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 value in rats was reported 5600 mg/kg. The substance is not classified on GHS regulation.
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 considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Jenner et al., 1964
GLP compliance:
not specified
Details on oral exposure:
The animals are rats (5 males and 5 female).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 790 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 2790 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
Letizia CS et al; Food Chem Toxicol 41 (7) : 965-76 (2003)
GLP compliance:
not specified
Details on oral exposure:
The animals are male and female rats
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 864 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 value in rats was reported 2864 mg/kg. The substance is classified category 5 on GHS regulation.
Endpoint:
acute toxicity: oral
Type of information:
other: bibliography
Adequacy of study:
weight of evidence
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data considered reliable by ECHA.
Qualifier:
no guideline available
Principles of method if other than guideline:
European Chemicals Bureau; IUCLID Dataset for 7-methyl-3methyleneota-1,6-diene (123-35-3). p8 (2000 CDROM edition). Available from, as of October 25,2011.
GLP compliance:
not specified
Details on oral exposure:
The animals are rats.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 value in rats was reported >5000 mg/kg. The substance is not classified on GHS regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 138 mg/kg bw

Additional information

Justification for classification or non-classification

With a DL50 oral estimated at 2138 mg/kg, the substance is not classified H302.