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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:
weight of evidence
Study period:
January 27, 2000 - March 17, 2000
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Not a validated method for determining skin irritation or skin sensitisation, but provides supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations. It is a 9-days cumulative application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to a previously unpatched test site.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Remarks:
(not applicable)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: aqueous solution
- Appearance: clear liquid
- Composition of test material, percentage of components: see section confidential details on test material

Method

Type of population:
general
Ethical approval:
other: Informed Consent (CFR title 21, Part 50) was obtained from each human subject in the study
Subjects:
-A total of 109 human subjects started the study (14 males and 95 females ranging in age from 18 to 68 years)
-A total of 99 human subjects completed all phases of this study
Clinical history:
No data
Controls:
Not applicable
Route of administration:
dermal
Details on study design:
- Amount(s) applied (volume or weight with unit): 0.2 mL
- Concentration (if solution):
Separately reported: 0.5% of the aqueous solution (solid content: 0.15%)
INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours

Results and discussion

Results of examinations:
no irritating nor sensitisation reactions observed

Any other information on results incl. tables

-Ten subjects (10/109) discontinued for personal reasons unrelated to the conduct of the study

-Scattered, transient, barely perceptible (+) to mild (1-level) non-specific patch test responses were observed on nine test panelists during the induction phase of the study

-During challenge phase, two test panelists exhibited barely perceptible responses at the 24- and/or 48-hour evaluations. There was no reactivity observed on either subject by the 96-hour evaluation

Applicant's summary and conclusion

Conclusions:
Under the conditions of a repeated insult (occlusive) patch test procedure, a 0.5% aqueous dilution of the aqueous solution of the test material (solid content 0.15%) did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.