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No human studies  were available for Chloramine B trihydrate, however case studies and reviews were available for Chloramine T, either diluted or undiluted, as described. From these studies, it is clear that Chloramine T is a skin and respiratory sensitizer, therefore Chloramine B trihydrate is also considered to be a human and respiratory sensitizer.

Additional information

No human studies were available for Chloramine B trihydrate, however case studies and reviews were available for Chloramine T, either diluted or undiluted, as described.

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.

- A case study of occupational allergic contact urticaria from Chloramine T in a 48-year old hospital bath attendant with itchy hand dermatitis was described, accompanied by whealing on the wrists and forearms from spilling of a liquid disinfectant, Klorilli® (containing 8.5% sodium –p-Toluenesulfonchloramine, CAS 127-65-1, i.e. Chloramine T) (Kanerva et al., 1997). She also developed stuffiness of her nose and sneezing when working with Klorilli®. She daily diluted concentrated Klorilli® to a 2% solution before use. Prick testing with Chloramine T conjugated with human serum albumin (HSA) or in aq. gave positive reactions. A radioallergosorbent test (RAST) to Chloramine T showed specific IgE antibodies. A provocation test with 2% Klorilli® was negative on intact skin but provoked a reaction on a skin site that 1 h earlier had been used for prick testing. A provocation test with undiluted Klorilli® containing 8.5% Chloramine T provoked a strong whealing reaction on intact skin.

- Respiratory symptoms developed in 5 patients who were exposed to Chloramine T in cleaning butcheries, kitchens, and operating theatres (Dijkman et al., 1981). Skin tests, performed in 4 patients, showed an immediate type of wheal and flare reaction followed by a late-type infiltrative reaction. In 3 patients, inhalation tests with Chloramine-T were done. 1 patient showed asthmatic bronchial obstruction, immediately after inhalation, followed by a late-type asthmatic reaction after some hours. 2 patients only exhibited late-type reactions, 4-8 h after challenge. The late bronchial response lasted for several hours or even days and was accompanied by leukocytosis in all 3 patients and a slight fever in 1 patient. No evidence of alveolar involvement appeared. Pre-challenge inhalation of cromoglycate in 1 patient ameliorated the late response considerably.

- A 36-year-old non-atopic female cleaner presented with sneezing, bronchial coughing and dyspnoea a few months after she started to use a new disinfectant at work (Kujala et al., 1995). The respiratory symptoms appeared immediately after the exposure to Chloramine T and continued several hours after the working shift. The symptoms disappeared when she had stay out of work. A diagnosis of Chloramine T induced occupational asthma was confirmed on the basis of positive skin prick test, RAST, bronchial provocation test results, adequate workplace exposure, and onset of work-related asthmatic symptoms. Skin prick tests with common inhalant allergens were negative. Skin prick test with Chloramine T solution (0.5 mg/mL) showed an immediate wheal and flare reaction. Bronchial provocation showed rhinorrhoea, coughing, dyspnoea and bronchial wheezes.

- Seven brewery workers developed asthmatic symptoms after using Chloramine T powder as a sterilising agent (Bourne et al., 1979). They gave positive wheal and flare reactions to skin-prick tests with solutions of chloramines at strengths that caused no reactions in unexposed controls. The symptoms did not recur once the men had been removed from areas in which chloramines was handled. As well as causing irritant effects, inhaling dry or liquid aerosols of chloramine may cause sensitisation, with workers being prone to allergic asthma on re-exposure. In view of this, measures should be taken to ensure that chloramine is not inhaled.

- Finally, an increasing frequency of respiratory hypersensitivity among dental personnel to Chloramine T was described (Piirilä P. et al., 2002).

A total of 64 cases of occupational respiratory diseases (ORDs) were diagnosed in dental personnel during 1975 to 1989; two cases in 1975 to 1989, and 62 in 1990 to 1998. Twenty-eight cases were of occupational asthma (18 caused by methacrylates), 28 occupational rhinitis (six caused by methacrylates), seven allergic alveolitis and one organic dust toxic syndrome (ODTS). The non-acrylate-material diagnosed in 1990-1998 comprised three cases of asthma and one of rhinitis caused by Chloramine T (sodium-N-chlorine-p-toluenesulphonamide); as well as one case of asthma, seven cases of rhinitis, and two cases of combined rhinitis and conjunctivitis caused by natural rubber latex (NRL). Furthermore, one case of occupational rhinitis caused by Nobetec containing colophony was diagnosed. The incidence rate (IR) of ORD increased from 0 in 1998 to a peak of 105.1 new cases per 100,000 working years in 1995. During the last observation year, i.e. 1998, the IR was 55 new cases per 100’000 workers. The IR in dental personnel was lower than in the whole working population in Finland up until 1992, but since then has been greater than in the whole population, peaking in 1995 when the IR of dental personnel was 2.55 times greater than in the whole population. 

From these studies, it is clear that Chloramine T is a skin and respiratory sensitizer, therefore Chloramine B trihydrate is also considered to be a human and respiratory sensitizer.