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Registration Dossier
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EC number: 204-847-9 | CAS number: 127-52-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
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.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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
to eyes.
Justification for selection of skin irritation / corrosion endpoint:
Key study
Justification for selection of eye irritation endpoint:
Waiver: the substance is classified as irritating to eyes with risk of serious damage to eyes
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
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.
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