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EC number: 204-847-9
CAS number: 127-52-6
A key study for acute dermal irritation/corrosion in New Zealand rabbits showed well defined erythema and slight oedema, which was not extincted at 72 hours after exposure, so these three test animals were then observed for 14 days, by when the lesions on the skin were almost healed. The test substance is considered irritant, but no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. As the test substance was shown to be a skin irritant, an in vivo eye test was not performed based on the testing and evaluation strategy in OECD TG 405 and EU method B.5. Instead the substance is classified as eye irritant.
Chloramine B trihydrate was tested in a key study
for acute dermal irritation/corrosion in New Zealand rabbits according
to EU method B.4 and OECD TG 404 (Dvorakova, 2006c). Test substance was
applied first on the skin of one rabbit. Well defined erythema and
slight oedema (edges of area well defined by definite raising) were
caused by 4-hour exposure to Chloramin B at 1 hour, 24, 48 and 72 hours
after exposure of the test substance. In confirmatory test, other two
rabbits were used. In these two test animals the skin irritation
symptoms of different severity (erythema, oedema, crust and eschar
formation) were observed in scheduled time intervals. No extinction of
irritant lesions was recorded at 72 hours after exposure, so these three
test animals were then observed until the end of observation period.
During the 14-day observation period, the lesions on the skin were
almost healed: the symptoms of irritation effect (crust, erythema,
oedema) persisted to the end of period but in much lesser extent. The
test substance is irritating , but no symptoms of systemic toxicity were
observed in the animals during the test period and no mortality occurred.
As the test substance was shown to be a skin
irritant, an in vivo eye test was not performed based on the testing and
evaluation strategy in OECD TG 405 and EU method B.5. Instead the
substance is classified for eye irritation. In Introduction to the EU
Method B.5 Acute Toxicity: Eye irritation/Corrosion it is stated:
“This method includes the recommendation that prior
to undertaking the described in vivo test for acute eye
irritation/corrosion, a weight of evidence analysis should be performed
on the existing relevant data.”
Before the eye irritation/corrosivity test with the
test substance the skin test was performed
according to EU method B.4 Acute Toxicity: Dermal Irritation/Corrosion,
Directive 2004/73/EC. Published in O.J. l152, 2004(Study No. 21/06/4,
Test report No. 06100).
According to the testing strategy an in vivo eye test was not performed.
The test substance, Chloramin B trihydrate is assumed to be irritating
Chloramine B trihydrate needs to be classified for
skin irritation according to the Directive 67/548/EEC, Annex VI with
symbol Xi and the indication of danger “irritant”; the following risk
phrase shall be assigned: R38 - Irritating to skin. For the eye
irritation, testing was waived but based on the skin irritation,
Chloramine B trihydrate was classified as irritating to eyes and
the risk phrase R36- Irritating to eyes shall be assigned. For the
respiratory tract, no study was available, but Chloramine B trihydrate
was classified as respiratory irritating and the risk phrase R37-
Irritating to respiratory system shall be assigned.
According to CLP regulation (No. 1272/2008 of 16
December 2008), Chloramine B trihydrate is classified as Category 2,
with signal word 'warning' and hazard statement: H315 - Causes skin
irritation. For the eye irritation, Chloramine B trihydrate is
classified as Category 2, with signal word 'warning' and hazard
statement: H319 -Causes serious eye irritation. For the respiratory
tract, no study was available, but Chloramine B trihydrate was classified
as respiratory irritating and the hazard phrase H335- May cause
respiratory irritation shall be assigned.
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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