Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

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.


Migrated from Short description of key information:
A key study for skin sensitisation was performed according to EU Method B.6/ OECD TG. 406, i.e. Magnusson and Kligman maximization procedure . In this study, Chloramine B trihydrate caused a positive reaction in 9/20 guinea pigs, e.g. in 45% of animals, which was considered to be positive for skin sensitisation.

Justification for selection of skin sensitisation endpoint:
key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Cfr. Section 7.10 Sensitisation data (humans)


Migrated from Short description of key information:
No studies were available for Chloramine B trihydrate, however human case studies and reviews were available for Chloramine T. From these studies, it is clear that Chloramine T is a skin and respiratory sensitizer, therefore Chloramine B trihydrate may also be considered to be a human and respiratory sensitizer.

Justification for selection of respiratory sensitisation endpoint:
Based on human respiratory sensitisation data (case studies)

Justification for classification or non-classification

Chloramine 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. 

Chloramine 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.