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EC number: 941-167-8
CAS number: 1584709-99-8
Not sensitising (OECD 406, GLP, K, rel. 1)
cutaneous reaction was recorded in the treated and control groups during
the induction phase.
the treated and control groups, no cutaneous reaction attributable to
allergy was recorded in animals after the challenge phase. In both
groups, no cutaneous intolerance reaction was recorded on the treated
area with liquid paraffin at 24 and 48 h.
No mortality was observed during the test.
weight: No abnormality was recorded in the body weight gain of both
In a Magnusson & Kligman maximisation study
(GPMT) performed according to OECD Guideline 406 and in compliance with
GLP, female Dunkin-Hartley guinea pigs were treated as follows:
After induction (intradermal injection at
20% and topical application at 100%) of 10 Guinea Pigs of treated group
with the test item ST 11 C 13 and a 10-day rest phase, the challenge
phase, under occlusive dressing for 24 h, consisted to a single topical
application of the test item at 100% and liquid paraffin as control.
Control group of 5 females treated in similar manner. The test
concentrations for the main study were determined from a preliminary
In the treated group (treatment dose of
100%), no cutaneous reaction attributable to allergy was recorded in
animals 24 and 48 h after the challenge phase. In the control group
(associated with the treatment dose of 100%), no cutaneous intolerance
reaction was recorded at 24 and 48 h. In both groups, no cutaneous
intolerance reaction was recorded on the treated area with liquid
paraffin, at 24 and 48 h. No mortality was observed during the test. No
abnormality was recorded in the body weight gain of both groups.
The sensitivity of the guinea-pig was
checked with known sensitiser i.e., α-Hexylcinnamaldehyde indicating the
validity of the study.
the test conditions, test item ST 11 C 13 is not classified as
sensitiser according to the Regulation (EC) No. 1272/2008 (CLP) and to
A key study was identified (Phycher, 2015).
In this dermal sensitisation study performed according to the OECD
guideline No. 406 and in compliance with GLP, the test material was
tested in ten female Guinea Pigs using the Magnusson and Kligman method
(10 treated animals + 5 controls). The preliminary study determined the
concentration to be used for the induction and challenge phases of the
main study. The test material diluted in olive oil at 20% (w/w) was
administered by injection for intradermal induction. On Day 7, the
animals received a topical application of sodium lauryl sulfate in
vaseline (10% w/w), in order to induce local irritation. On Day
8, topical induction was performed with the test material as supplied.
For the challenge, on Day 22, the test material was tested undiluted.
90% animals gave positive response to
challenge concentrations of the last historical positive control
α-Hexylcinnamaldehyde at a concentration of 12.5% at 24h and 48h. 50%
and 70% positive response were noted at 24h and 48h respectively at a
concentration of 6.25%. The test system was therefore considered to be
In both groups, no clinical signs and no
deaths were noted during the study. The body weight gain of the treated
animals was similar to that of the control animals. After the challenge
application, no cutaneous reaction was noted. The overall sensitisation
rate was 0%.
Under the test conditions, the test material
is not a skin sensitizer.
substance has no harmonized classification according to the Regulation
(EC) No. 1272/2008.
on the available data no additional self-classification is proposed
according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
data was available for respiratory sensitisation. However, this
substance is not a skin sensitizer, therefore according to Figure R.7.3
-2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not
considered as a respiratory sensitizer.
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