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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deficiencies.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Public available literature. No guideline indicated. For details on method see materials and methods section in IUCLID5 dossier.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hypochlorite
EC Number:
231-668-3
EC Name:
Sodium hypochlorite
Cas Number:
7681-52-9
Molecular formula:
ClO.Na
IUPAC Name:
sodium hypochlorite
Details on test material:
Sodium hypochloriteHalasol: 4-6 % NaOCl

Method

Type of population:
occupational
Ethical approval:
not applicable
Subjects:
Sex: maleAge/weight: 46 years old / weight not indicatedKnown Diseases: not indicatedNumber of persons: 1
Clinical history:
The patient had itchy skin lesions of 3-4 years´ duration on both hands and forearms. He has worked as a veterinary surgeon for 20 years. He came also in contact with Betadine (povidine iodine) as an antiseptic and various antibiotics. It was known that his skin eruption increased and decreased with steroid treatment. The lesions aggravated after obstetric work.During his work he has occasionally washed his hands and forearms with undiluted Halosol (containing 4-6 % NaOCl) as an antiseptic. Halosol is recommended for antiseptic purposes in animals. The patient used it for the animals as well as for antisepsis of his own skin. For direct use on the human skin only concentrations of NaOCl of 0.45-0.5 % are recommended.
Route of administration:
dermal
Details on study design:
Reason of exposure: Misuse during occupational applicationFrequency of exposure: OccasionallyOverall time period of exposure: Up to 20 yearsDuration of single exposure: Short-termExaminations: Patch tests (Hollister standard battery, various antibiotics and antiseptics, dilutions of Halosol and sodium hypochlorite)

Results and discussion

Results of examinations:
Clinical SignsItchy skin lesions on both hands and forearmsScratch tests with cow´s placenta and cow´s hair all gave negative reactions. The patient was sensitive to dilutions of sodium hypochlorite as low as 100 times that of Halosol, i.e. 0.04-0.06 % sodium hypochlorite, and to undiluted Halosol. All of the 3 normal healthy controls showed negative results. Therefore the authors of this study concluded that the patient is sensitive to the sodium hypochlorite in Halasol.

Any other information on results incl. tables

Effectivity of medical treatment

No medical treatment was performed. Avoidance of Halasol resulted in markedly improvement of the patient´s skin eruption, especially on the forearms. Hyperkeratotic and mildy eczematous skin lesions remained one month later, probably due to his wet working conditions.

Applicant's summary and conclusion

Conclusions:
This study reports one case of skin irritation due to occupational misuse of Halasol containing 4-6 % sodium hypochlorite
Executive summary:

This publication describes one case of occupational contact dermatitis due to an disinfectant containing sodium hypochlorite in a veterinary surgeon. The patient had itchy skin lesions on his hands and forearms. Patch tests were carried out with Hollister standard battery, various antibiotics and antiseptics, dilutions of Halosol and sodium hypochlorite.

In the Patchtest the patient was sensitive to dilutions of sodium hypochlorite and to undiluted Halosol. All of the 3 normal healthy controls showed negative results. Therefore the authors concluded that the patient is sensitive to the sodium hypochlorite in Halasol. Avoidance of Halasol resulted in improvement of the symptoms.

However, in view of the known irritant and corrosive properties of sodium hypochlorite, the effects reported suggest an irritation rather than a sensitizing potential.

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