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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: acceptable, well-documented study report which meets basic sientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated Insult Patch test (modified Shelanski (4 x 4 method))
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 97.4 %

Method

Type of population:
general
Route of administration:
dermal

Results and discussion

Results of examinations:
sensitising

Any other information on results incl. tables

Forty-five subjects completed the study. During the induction period, eleven subjects demonstrated intense irritation consisting of erythema and induration. These responses were considered indicative of an allergic reaction. due to the severity of reaction during the induction period, these eleven subjects were not tested during the portion of the induction phase which followed their response. Following the single 24 hour challenge application, six subjects demonstrated slight to moderate erythema. Twenty-four hours after removal of the test material, mild to intense inflammatory changes were observed in 15 individuals. At 48 hours after removal, responses were still noted in 13 subjects. These responses were considered characteristic for allergic contact dermatitis.

In conclusion, the test substance, tested as a 60 % preparation in petrolatum, produced sensitization in 13/54 subjects who completed the study. No evidence of primary irritation was observed.This chemical was considered to be a strong skin sensitizer.

Applicant's summary and conclusion