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EC number: 204-847-9
CAS number: 127-52-6
In contrast to the animal study for skin
sensitisation, tested on Chloramine B trihydrate, human (case) studies
were available on Chloramine T. A read-across justification was worked
out and separately attached in Section 13. Based on the data from the
repeated dose toxicity studies, as well as the comparable molecular
structure and similar physicochemical properties, it was concluded that
both data from Chloramine B trihydrate as those of Chloramine T and
metabolites such as BSA and p- and o-TSA can be used for read-across.
In a key study (Plodikova, 2006) Chloramine B
trihydrate, was tested for the assessment of skin allergic effects using
albino guinea pigs.
The test was performed according to EU Method B.6,
Skin sensitisation, which is analogous to OECD Test Guideline No. 406,
Skin sensitisation. The Magnusson and Kligman maximization procedure was
followed. The experiment proceeded in three phases: intradermal
induction - topical induction – topical challenge. Potential skin
reactions were evaluated at the end of experiment.
The test substance caused a positive reaction in 9 of 20 guinea pigs,
e.g. in 45% of animals which were exposed to the test substance.
Section 7.10 Sensitisation data (humans)
B trihydrate needs to be classified for skin sensitisation according to
the Directive 67/548/EEC, Annex VI with symbol Xi with the following
risk phrase: R43 - May cause sensitization by skin contact. According
to CLP regulation (No. 1272/2008 of 16 December 2008), Chloramine B
trihydrate is classified as Category 1, with signal word 'warning' and
hazard statement: H317 - May cause an allergic skin reaction.
B trihydrate needs to be classified for respiratory sensitisation
according to the Directive 67/548/EEC, Annex VI with symbol Xn with the
following risk phrase: R42 - May cause sensitization by inhalation.
According to CLP regulation (No. 1272/2008 of 16 December 2008),
Chloramine B trihydrate is classified as Category 1, with signal word
'danger' and hazard statement: H334 - May cause allergy or asthma
symptoms or breathing difficulties if inhaled.
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