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Diss Factsheets

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The data are based on a publication and various details are not provided.

Data source

Reference
Reference Type:
publication
Title:
Occupational allergic contact urticaria from chloramine-T solutions
Author:
Kanerva L., Alanko K, Estlander T. , Shivonen T. and Jolanski R.
Year:
1997
Bibliographic source:
Contact Dermatitis 1997: 37: 180

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
CAS 127-65-1
IUPAC Name:
CAS 127-65-1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Klorilli®; containing 8.5% Chloramine-T (sodium-p-toluenesulfonchloramine)
- Molecular formula (if other than submission substance): CH3C6H4SO2NNaCl• 3H2O
- 2% solution of Klorilli® contained 0.17% Chloramine-T

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 1
- Sex: Female
- Age: 48 years
- Race:
- Demographic information: Finland
Route of administration:
dermal
Details on study design:
Prick testing with standard environmental allergens
Prick testing with Chloramine T conjugated with human serum albumin (HSA)

Results and discussion

Results of examinations:
Prick testing with standard environmental allergens and flours was negative. Prick tests with chloramines-T conjugated with human serum albumin (HSA) or in aq. gave the following reactions: Chloramine T-HSA 1.5% 15 mm diameter; Chloramine T 1% aq. 9 mm , 0.1% aq. 6mm, 0.01% aq. 5mm and 0.001% aq. 2mm. Histamine hydrochloride 10 mg/mL gave a 6 mm reaction, whereas control tests with the vehicles (HSA and aq.) were negative. A radioallergosorbent test (RAST) to Chloramine T (Pharmacia & Upjohn, Sweden) was performed 2 x; it showed specific IgE antibodies, 9.1 kU/L and 6.4 kU/L, respectively, values >0.3 kU/L being defined as positive. A provocation test with 2% Klorilli® was negative on intact skin but provoked a 4-mm 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. On patch testing, the patient had a +++ reaction to nickel sulphate in the standard series. The antimicrobial series was negative, and chloramines-T was negative in a dilution series (0.5%-0.001% aq.). It was concluded that the patient had developed occupational allergic contact urticaria from Chloramine T.

Applicant's summary and conclusion

Conclusions:
It was concluded that the patient had developed occupational allergic contact urticaria from Chloramine T.
Executive summary:

A 48-year old hospital bath attendant developed itchy hand dermatitis. Half a year later, her dermatitis was 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). Spillings had caused no skin reactions during the previous 6 months of exposure. She also developed stuffiness of her nose and sneezing when working with Klorilli®. She daily diluted concentrated Klorilli® to a 2% solution before use. She used disposable vinyl gloves and the reaction to Klorilli® appeared only on the unprotected skin of the wrists and forearms. Both concentrated and diluted Klorilli® caused symptoms. The diluted Klorilli® was used to disinfect surfaces in the hospital bathrooms. Accordingly, the diluted 2% solution of Klorilli® contained 0.17% of chloramine T.

Prick testing with standard environmental allergens and flours was negative. Prick tests 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. On patch testing, the patient had a +++ reaction to nickel sulphate in the standard series. The antimicrobial series was negative, and Chloramine T was negative in a dilution series. It was concluded that the patient had developed occupational allergic contact urticaria from Chloramine T.