Registration Dossier

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.