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EC number: 230-603-6
CAS number: 7216-56-0
Two studies are avialble on d-limonene, one main
impurity of the registered substance.
In a GLP study conducted in compliance with
OECD guideline 429 with d-limonene in ethanol/diethyl phthalate, an EC3
value of 22% was obtained.
In an study conducted similarly to OECD
guideline 429 with limonene in acetone/olive oil, an EC3 value of 68.5%
In a local lymph node assay performed in
CBA/Ca strain mice according to OECD Guideline 429 and in compliance
with GLP, 25 µL of d-limonene were applied to the dorsal surface of each
ear of groups of mice (4 females/dose) at concentrations of 0 (vehicle
control), 10, 25, 50, 75 or 100% v/v in ethanol/diethyl phthalate (3: 1
v/v) for three consecutive days. On Day 6, all animals were injected
with 3H-methyl thymidine and after five hours the draining (auricular)
lymph nodes were excised and radioactivity was measured expressed as
number of disintegrations per minute (DPM). Historic data of
hexylcinnamaldehyde (5, 10 and 25 % w/v) in acetone/olive oil (4:1 v/v)
was used as the data for positive control group. Mean DPM for 0, 10, 25,
50, 75 or 100% d-limonene were observed to be 2511, 3319, 8554, 9916,
22063 or 16259 dpm, respectively. Stimulation index for 10, 25, 50, 75
or 100% d-limonene were calculated to be 1.3, 3.4, 4.0, 8.8 or 6.5,
respectively. The estimated concentration giving rise to a 3 fold
increase in lymphocyte proliferation (EC3) was 22% v/v (5500 µg/cm2). No
increase in visual levels of irritancy to the ear skin was observed
during the study.
a skin sensitization study conducted following a method similar to OECD
Guideline 429, four groups of CBA/Ca strain female mice(4
exposed topically on the dorsum of both ears to 25 µL of vehicle
(acetone/olive oil, 4:1 v/v), 25, 50 and 100% v/v of d-limonene daily
for 3 consecutive days. Five days following initiation of exposure all
mice were injected 250 µL of phosphate buffered saline (PBS) containing
20 µCi of [3H] methyl thymidine (3H-TdR). The animals were then
sacrificed after 5 hours and suspension of lymph node cells was prepared
from auricular lymph nodes. The incorporation of 3H-TdR was measured by
β-scintillation counting as disintegrations per minute (dpm) per node
for each experimental group. A
Stimulation index of 3 or greater was considered to be indicative of a
potential to cause contact sensitization.
at exposure concentration of 0 (vehicle), 25, 50 and 100% v/v resulted
in 476, 877, 1164 and 1882 dpm/node and stimulation index of 1, 1.84,
2.44 and 3.95, respectively. The
calculated EC3-value for d-limonene was found to be 68.5%.
was found to be a skin sensitiser and should be classified as skin
sensitisers category 1B according to the criteria of CLP Regulation (EC)
No 1272/2008. As the registered substance contains more than 1% w/w of d-
and l-limonene, which are the main impurities of the registered
substance, it should also be classified as skin sensitiser category 1B
according to the criteria of classification for mixtures of CLP
Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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