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EC number: 227-815-6
CAS number: 5989-54-8
Based on the read-across from an analogue substance the 21-d NOEC is
estimated to be 0.27 mg/L.
The acute toxicity of l-limonene to aquatic invertebrates was
estimated using the ECOSAR model from EPISUITE 4.1 reported as a valid
model by ECHA (R6: QSAR and grouping of chemicals, May 2008). ECOSAR
computes toxicity based on a linear mathematical relationship between
the predicted log Kow values and the corresponding log of the measured
toxicity values (mmol/L). l-limonene feld in the applicability domain of
this QSAR model. The calculation was ran using the experimental log Kow
value of 4.38 and water solubility of 12.3 mg/L for d-limonene as these
values are expected to be similar
for both enantiomers.
The result of the computer modelling to estimate the chronic
toxicity of l-limonene on daphnid after 16 days exposure is ChV
(geometric mean of NOEC and LOEC)= 0.115 mg/L.
This ECOSAR prediction of chronic toxicity of l-limonene on daphnids is
adequate for the purpose of risk assessment and classification and
Weight of evidence: Experimental data are available on dipentene from
the Japan Ministry (formerly MITI) which measured chronic toxicity
values on daphnia of 21d-EC50= 0.49 mg/L and 21d-NOEC=0.27 mg/L. These
values are in line with the acute toxicity values measured on the same
organism and with an adequate QSAR prediction (ECOSAR) calculating a
16d-ChV of 0.115 mg/L (corresponding to the geometric mean of NOEC and
LOEC). Therefore the experimental NOEC value on dipentene is estimated
to be the relevant value to be considered for risk assessment and
Classification & Labelling purposes.
For this endpoint, an experimental value is derived from the Japan
Ministry (formerly MITI) study on the dipentene racemic form. The values
of 21d-EC50= 0.49 mg/L and 21d-NOEC = 0.27 mg/L are
reported but there is no detail on test material and conditions.
The software ECOSAR was used to assess the toxicity of l-limonene
based on his smiles characterisation and the experimental values of Log
Kow and water solubility of d-limonene which are expected to be similar
for both enantiomers. Considering its neutral organic status, the
resulting value for chronic aquatic toxicity was 16d-ChV= 0.115 mg/L
corresponding to the geometric mean of the NOEC and the LOEC.
Therefore, the available chronic toxicity data on daphnia form
MITI (experimental) and ECOSAR (calculated) belong to the same range and
are similar with the validated study results.
From theses observations, it can be concluded:
- that both enantiomers, l and d limonene, have the same chronic
toxicity level against daphnids.
- that the MITI studies on which we have little information, were
conducted in conditions that were accurate enough to measure effects at
the very low concentration levels corresponding to the one measured in
the validated study. It reveals that the properties of the substance as
regard to degradation or volatilisation were taken into account and/or
the real concentrations measured. Indeed other available data, resulting
of studies which didn’t consider these testing difficulties, belong to
the range of 10-100 mg/L.
Therefore it is estimated that the experimental value of 21d-NOEC=
0.27 mg/L is adequate for risk assessment and Classification & Labelling
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