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EC number: 200-521-5
CAS number: 61-82-5
Not sensitising (OECD 406, GLP, K, rel. 1)
A key study was identified (CIT, 1997). In this dermal sensitisation
study performed according to the OECD guideline No. 406 and in
compliance with GLP, the test material was tested in a group of 20
Guinea Pigs (10/sex) using the Magnusson and Kligman method (20 tested
animals + 10 control animals). The preliminary study determined the
concentration to be used for the induction and challenge phases of the
main study. The test material diluted in physiological saline at 10%
(w/v) was administered by injection for intradermal induction on Day 1.
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. After a rest period of 14 days, a second challenge was
performed on Day 36 under the same experimental conditions.
The sensitivity of the guinea-pigs was satisfactory since 50% of the
animals showed a positive reaction with positive control 2,4
No clinical signs and no deaths were noted during the study. No
cutaneous reaction was noted in the control animals after the first and
the second challenge.
In the treated group, after the first cutaneous challenge application,
the observed cutaneous reactions were attributed to a sensitising effect
of the test substance in 4/20 (20%) animals (score of erythema =2) This
result was confirmed after the second challenge application with a
positive reaction observed in 3/20 animals.
Under the test conditions, the test material is not a skin sensitizer.
substance has no harmonized classification for sensitisation according
to the Regulation (EC) No. 1272/2008.
on the available data no additional self-classification is
proposed according to the Annex VI of 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 sensitiser.
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