Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed study with sufficient documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The purpose of this study was to evaluate the potential of the test material as a result of repeated applications, to induce dermal sensitization in human subjects.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): H126-2; Hydroxycitronellal
- Storage condition of test material: Protected from light, kept refrigerated and brought to room temperature prior to application to patches.
no futher data given

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 100
- Sex: 32 males and 68 female
Clinical history:
No subject was used if he or she exhibited any dermatological or other medical or physical condition which would preclude topical application of the Test Material. No known pregnant nor nursing women were used an this RIPT.
Controls:
Same individuals were treated with saline and vehicle (EtOH:DEP 1:3)
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: repeated insult patch test
ADMINISTRATION
- Type of application: occlusive
- Description of patch: webril/adhesive patch (25 mm Hill Top Chamber)
- Vehicle / solvent: 3:1 diethyl phthalate:ethanol
- Concentrations: 4.2%
- Volume applied: 0.3 ml
EXAMINATIONS
- Grading/Scoring system: The test sites were scored using the modified scoring scale of the International Contact Dermatitis Research Group System (Fisher, A., Contact Dermatitis, 1986) as follows:
0 = no visible reaction,
+/- = faint, minimal erythema,
1 = erythema,
2 = intense erythema,
3 = intense erythema, induration, vesicles,
4 = severe reaction with erythema, induration, vesicles, pustules (may be weeping),
E = edema

Results and discussion

Results of examinations:
Induction:
1 subject exhibited a 1-level erythema plus edema reaction at induction application 3 with 4.2% hydroxycitronellal; the test site was changed. The new test site exhibited a low-level, transient (+/- and 1) reaction. Two other subjects showed low level transient (+/-) erythema with 4.2% hydroxycitronellal.
3 subjects exhibited low level transient (+/-) erythema reactions with saline.
1 subject exhibited low level transient (+/-) erythema reactions with vehicle DEP:EtOH.


Challenge:
Faint, minimal erythema (+/-) after patch removal was observed in 1 subject with 4.2% hydroxycitronellal only 72 and 96 hours post-patching.
One subject exhibited a 1-level erythema plus edema reaction and 3 other subjects showed low level transient (+/-) erythema with saline.
No reactions were exhibited with 3:1 DEP:EtOH in any subjects tested.

Any other information on results incl. tables

One subject received 9 induction patchings but was unable to return to the laboratory for the final induction reading/scoring; she was therefore given a reading of N9R (no 9th reading). One subject missed the C1 visit; he was instructed to keep his patches on until he returned for the C2 visit. Two subjects missed the C4 visit. Both of the subjects returned to the laboratory on the following Monday and their test sites were negative. A verbal report from each of the subjects stated "no reaction present" at what would have been the C4 visit.

Applicant's summary and conclusion