Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated data from a reliable secondary source (WHO 2000 as well as US-CPSC).

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A dermal irritation study was conducted using human volunteers (n=38) exposed to fabric treated with Proban® 210 (production washed), Proban® NX washed during production, Proban® NX (laundered) or untreated fabric (Albright and Wilson 1982). The difference between these formulations was not specified. The fabric was delivered to the study authors as pretreated or untreated 1 cm x 1 cm pieces of undyed fabric. Single squares of the fabric were positioned on a 12.5 cm length of hypoallergenic ventilated non-stretch adhesive plaster about 1.5 cm apart. Each of the 4 types of samples was placed on the subject’s arm, about 1.5 cm apart. Plaster was applied without pretreatment of the skin. To ensure close adhesion to the skin, pressure was applied using a tubular bandage. Subjects were exposed to the fabric for 48 hours and the exposure site was evaluated at 50 and 96 hours and 1 and 2 weeks after the initial application.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Proban treated fabric

Method

Type of population:
general
Route of administration:
dermal

Results and discussion

Results of examinations:
Three subjects showed some reaction (erythema and scaling) to the test fabric and these were transient, barely perceptible, and in response to
different fabric treatments. One subject exhibited barely perceptible erythema at 50 hours after exposure to either untreated fabric or laundered Proban® NX treated fabric. Another subject showed barely perceptible scaling at 96 hours after treatment with laundered Proban® NX treated fabric. The third subject had barely perceptible erythemic reactions to all 4 fabrics, including the control. The erythema that was present in 2 subjects at 50 hours was not apparent at 60 hours. The study authors suggested that these effects did not result from treatment because there was no pattern of effect and that they probably resulted from adhesion of the test material to the skin, since the subjects removed the bandages themselves.

Any other information on results incl. tables

A review by Martin-Scott (1966) showed that earlier human data support these conclusions. The Martin-Scott article reported

that Proban manufacturers conducted patch tests in 256 volunteers; only a mild reaction was observed after a 48-hour

application. The formulation of the product used and whether or not it was applied to the fabric or directly to the skin was not

stated.

Applicant's summary and conclusion

Conclusions:
treated fabric is not dangerous.