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EC number: 227-815-6
CAS number: 5989-54-8
Based on the read-across from an analogue substance, the 72h-NOEC and
the 72h-EC50 was 1.6 and > 1.6 mg/L, respectively based on growth rate
and 21 and > 21 mg/L based on the cell number.
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 asthese
values are expected to besimilar
Results of computer modelling to estimate acute and chronic
toxicity in a 96 -hour freshwater algae study show that the EC50 and the
NOEC were 0.904 mg/L and 0.514 mg/L, respectively.
This ECOSAR prediction of acute and chronic toxicity of l-limonene on
algae is adequate for the purpose of risk assessment and classification
Based on the read-across from an analogue substance the 72h-NOELr and
72h-ELr50 towards Desmodesmus subspicatus were estimated to be 50 and
150 mg/l, respectively. The 72h-NOECr and 72h-ECr50 were circa 8 and 2.6
mg/l (measured, hydrocarbons).
Weight of evidence: A study performed according to OECD guideline 201
under GLP investigated the toxicity of orange oil (containing typically
>95% of d-limonene) towards Desmodesmus subspicatus. The result is
comparable to the result of a non assignable MITI study performed on
Pseudokircheneriella subcapitata with dipentene, the racemic of
limonene. These studies suggest that both enantiomers have the same
level of toxicity on algae. However, due to the uncertainities on the
purity of the substances tested, the slight lower toxicity values
calculated for l-limonene with a valid ECOSAR model are considered as
key values for the purpose of risk assessment and
Reliable experimental values for
algae, a 72h-ErC50 and a 72h-NOErC of 8 and 2.62 mg/L (measured
hydrocarbons), respectively, were derived from a study conducted
with orange oil on Desmodesmus subspicatus using WAFs.
Although the composition of orange oil was not reported, these values
were considered relevant, as typical content of d-limonene in orange oil
is > 95% and this study was performed according to OECD Guideline under
These values are comparable with the result
of a MITI study performed by the Japanese authority on Pseudokircheneriella
subcapitata with dipentene, the racemic form of limonene, giving a
72h-ErC50 and a 72h-NOErC of > 1.6 and 1.6 mg/L, respectively. This
study was assessed as non assignable because it is poorly documented
however it is considered as a reliable source and it suggests that both
enantiomers have the same level of toxicity on algae.
Finally, the software ECOSAR, a valid
QSAR, was used to assess the toxicity of l-limonene. The result was
calculated with its measured Kow value and with the measured water
solubility value of d-limonene which is expected to be similar for both
enantiomers. The estimated values for algae were lower than the
experimental values with a 96h-EC50 of 0.904 mg/L and a chronic toxicity
value of 0.514 mg/L. The ECOSAR model has been validated to estimate the
toxicity of l-limonene on algae.
Therefore, the estimated values by the
ECOSAR model are considered as the reliable values for the purpose of
risk assessment and classification&labelling.
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