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EC number: 227-815-6
CAS number: 5989-54-8
Key study: Read-across from the analogue susbtance d-limonene. Test
method OECD 429. GLP study. The estimated EC3 value is 68.5 %,
therefore, the substance is classified as skin sensitiser 1B according
to CLP Regulation.
Based on the read-across from the analogue substance d-limonene,
l-limonene is estimated to have an EC3 value of 68.5 %, therefore, the
substance is classified as skin sensitiser 1B according to CLP
Regulation (EC) Nº 1272/2008.
was no data on l-limonene. A read-across approach with the structural
analogue d-limonene was used to assess the sensitising potential of
l-limonene. For further
information on read-across justification, see section 13: point
study was identified as a key study (Warbrick,
2001). In this OECD
guideline 429 GLP study, d-limonene
at exposure concentration of 0 (vehicle), 25, 50 and 100% v/v resulted
in stimulation index of 1, 1.84, 2.44 and 3.95, respectively. The
calculated EC3-value for limonene was found to be 68.5% (17125 µg/cm²).
This value is close to reported LLNA weighed
mean EC3 values from five LLNA studies (=10075 µg/cm²). Moreover, these
animal data are consistent with the NOEL (highest concentration tested
with no sensitisation in human) found in humans, based on Human Repeated
Insult Patch Test (10000 µg/cm²) (see section 7.10.4).
on the results found with d-limonene, l-limonene was considered as skin
sensitising and is classified as Skin
Sens. 1B, H317 (May cause an allergic skin reaction) according to the
criteria of the Regulation (EC) No. 1272/2008 (CLP).
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