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EC number: 204-847-9
CAS number: 127-52-6
Key studies were available for acute oral and dermal toxicity testing with Chloramine B trihydrate. Acute Toxic Class oral testing in female rats resulted in LD50 between 300 mg/kg bw (no animals died) and 2000 mg/kg bw (all animals died). At 300 mg/kg bw, very mild clinical signs of intoxication (erected hair, hunched posture) were seen in 3 animals and liver dystrophy was seen at pathology in 3 other animals. Acute inhalation toxicity testing was waived based on low vapour pressure and large particle size. Acute dermal toxicity testing in rats resulted in LD50>2000 mg/kg bw. No clinical signs of toxicity were observed during the study, except for symptoms of skin irritation which were almost healed. Macroscopic changes included skin crusts and granular surface of the spleen in all animals.
In a key oral toxicity study (Dvorakova, 2006a),
Chloramine B trihydrate was administered by gavage in a single dose as
solution in water for injection to three groups of three female Wistar
rats: group No. 1 (first step) 2000 mg/kg bw, group No. 2 (second step)
300 mg/kg bw and group No. 3 (third step) 300 mg/kg bw. The test
substance administered at the dose of 2000 mg/kg bw caused death of all
three animals, clinical signs of intoxication were observed in all three
animals and macroscopic changes were diagnosed during pathological
examination in all three animals. The test substance administered at the
dose of 300 mg/kg bw caused no death in females, very mild clinical
signs of intoxication were observed in three animals (erected hair,
hunched posture) and macroscopic changes were diagnosed during
pathological examination in three females. According to the study
results the value of LD50 of the test substance Chloramin B for rats is
in the range >300 mg/kg bw to ≤ 2000 mg/kg bw. The exact value was not
given in the report, but can be considered to be around 1150 mg/kg bw.
No acute inhalation toxicity
data or studies directly for Chloramine B (Sodium
N-chlorobenzenesulphonamide trihydrate) are available. Chloramine B
trihydrate has a very low vapour pressure ranging between 1536 Pa (20°C)
and 1976 Pa (25°C), whereas Chloramine B showed a very low vapour
pressure value (2.44 x 10-9Pa ). Further, particle size distribution in
the tested sample of Chloramine B shows that only 1 % of particles are
less than 100 μm in diameter, thus Chloramine B practically cannot
penetrate in the alveolar region of the lungs.
More information is provided in waiver documentation,
attached to Section 13.
A key acute dermal toxicity study (Dvorakova,
2006b) was performed as limit test: two groups of animals (5 males and 5
females) at the dose of 2000 mg/kg bw. The test substance was applied
occlusively on the shaved skin of the test animals moistened with the
smallest amount of water for 24 hours.The test substance applied in dose
2000 mg/kg bw did not cause death of animals. No clinical signs of
toxicity were observed during the study in all animals, except for
symptoms of skin irritation which were almost healed. Macroscopic
changes were diagnosed during pathological examination in all animals
(skin: crusts; spleen: granular surface). According to the study
results the value of LD50 dermal of the test substance
Chloramin B trihydrate for rats of both sexes is higher than 2000 mg/kg
Chloramine B trihydrate needs to be classified for
oral acute toxicity according to the Directive 67/548/EEC, Annex VI. as
harmful and assigned the symbol Xn and the indication of danger
“harmful”; the following risk phrase shall be assigned: R22 -Harmful if
swallowed. For the acute dermal toxicity, Chloramine B trihydrate did
not fall into any categories of toxicity and has no obligatory labelling
According to CLP regulation (No. 1272/2008 of 16
December 2008), Chloramine B trihydrate is classified as Category 4 for
acute oral toxicity, with signal word "harmful" and hazard statement:
H302- Harmful if swallowed. For the acute dermal toxicity, Chloramine B
trihydrate did not fall into any categories of toxicity and has no
obligatory labelling requirement.
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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