Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
April 17, 2002 - May 24, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Not a validated method for determining skin irritation or skin sensitisation, but provides reliable supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations. The study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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:
It is a 9-days cumulative occlusive application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to a previously unpatched test site.
GLP compliance:
no
Remarks:
(not applicable)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): CITRATHAL R
- Description: Colourless to pale yellow liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): C-61594I
- Description: clear liquid

- The test material contains 3% of the registered substance (Citrathal R)
- The used solvent is unknown and was not studied

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 55 human subjects started the study (13 males and 42 females ranging in age from 18 to 67 years)
-A total of 52 human subjects completed all phases of this study; 3 human subjects discontinued for personal reasons unrelated to the conduct of the study
Clinical history:
The human subjects did not exhibit any physical or dermatological condition that would have precluded application of the test material or determination of potential effects of the test material. No further data available.
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): 3%
- The test material was volatilized at least 30 minutes, but less than 90 minutes, on the patch, prior to application

INDUCTION EXPOSURE (occlusive)
- No. of exposures: 9
- Exposure period: 24 hours

CHALLENGE EXPOSURE (occlusive)
- No. of exposures: 1
- Exposure period: 24 hours

Results and discussion

Results of examinations:
- A barely perceptible (+) patch test response was observed in 1 human subject during the induction phase, after the first application. This reponse was judged to be non-specific in nature and is not indicative of clinically significant irritation, as it was seen only after the first of 9 applications in this human subject.
- No responses were observed during the challenge phase

Applicant's summary and conclusion

Conclusions:
Under the conditions of a repeated insult (occlusive) patch test procedure, a 3% solution of the substance did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
Executive summary:

Under the conditions of a human repeated insult (occlusive) patch test procedure, a 3% solution of the substance did not show any evidence of induced allergic contact dermatitis in 52 human subjects. During induction, the 3% solution was applied to the back three times per week for three successive weeks. Sites were covered for 24 hours with occlusive patches. Repeated applications were made to the same test sites. Reactions were scored 48 or 72 hours after each induction application according to the Draize scale. The challenge phase was initiated approximately 2 weeks after application of the final induction patch. Challenge patches were applied for 24 hours to new sites; reactions were scored 48 and 96 hours later. It was reported that it did not induce skin sensitization in any of the 52 human subjects tested.