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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Reliability:
other: Any kind of reliability rating is not considered to be applicable, since human epidemiological studies, field studies and case reports are not conducted/reported according to standardised guidelines
Rationale for reliability incl. deficiencies:
other: Acceptable publication

Data source

Reference
Reference Type:
publication
Title:
Contact sensitization to allergens in the Spanish standard series at hospital Costa del Sol in Marbella, Spain: A retrospective study (2005-2010)
Author:
Aguilar-Bernier, M. et al.
Year:
2012
Bibliographic source:
Actas Dermosifiliogr. 103 (3): 223-228.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A retrospective study of patients with suspected contact dermatitis was undertaken at Hospital Costa del Sol in Marbella, Spain, for the period between January
1, 2005 and December 31, 2010; 839 patients were included in the analysis. Patch tests were carried out with 34 allergens, including the 29 compounds that comprise the Spanish standard panel proposed by the GEIDAC. Cobalt chloride (1% in pet) was one of the allergens tested.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cobalt dichloride
EC Number:
231-589-4
EC Name:
Cobalt dichloride
Cas Number:
7646-79-9
Molecular formula:
CoCl2
IUPAC Name:
Cobalt dichloride hexahydrate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): cobalt chloride

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 839 patients
- Sex: 531 women (63.3%) and 308 men (36.8%)
- Age: 12-90 years (mean age: 45 years)
Clinical history:
Area of the skin affected, diagnosis, and personal history of atopy were recorded. The patient’s occupation was also noted when this information was available.
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
The tests were performed with a standard series of 34 allergens, including the 29 compounds recommended by the GEIDAC. All the patients were tested with approved allergens (T.R.U.E TEST and Martí-Tor) applied using Curatest patch strips. The tests were performed using the standard procedure, and patients were instructed to avoid excessive movement, activities that cause sweating, and bathing.

EXAMINATIONS
- Grading/Scoring system: readings were taken at 48 and 96 hours, although only the positive results at 96 hours were included in the analysis. Patients who developed erythematous papular or vesicular lesions were considered to have positive reactions; the intensity of the reaction was graded as +, ++, or +++ according to the recommendations of the International Contact Dermatitis Research Group. Only clearly positive or negative reactions were included in the final analysis. Equivocal and irritant reactions (<1%) were not considered.

- Statistical analysis: the frequency distribution of all the study variables were analysed and a forward stepwise multiple logistic regression model for the dependent variable (presence or absence of sensitization) was built, with an entry criterion of P = .05 and an exit criterion of P = 0.1. Odds ratios were presented with 95% CIs. Statistical significance was set at a level of P less than .05, and data were analysed using SPSS version 15.0.

The clinical relevance of the results, assessed on the basis of positivity, clinical manifestations, and history of exposure, was also recorded for each patient.

Results and discussion

Results of examinations:
- 4.5% of the patients reacted positive to cobalt chloride (1% in Pet)
- 28 females (5.3%) and 10 males (3.2%) showed a positive reaction to cobalt chloride (1% in Pet)
- analysis by age group showed that the prevalence of contact dermatitis increased with age.

Applicant's summary and conclusion

Conclusions:
4.5% of the 839 patients reacted positive to cobalt chloride (1% in Pet). Of these 839 patients 28 patients were females (5.3%) and 10 patients were males (3.2%). Analysis by age group showed that the prevalence of contact dermatitis increased with age.