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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: Well performed study with sufficient documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: HRL Protocol #100RIFM and HRL Standard Operating Procedures
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): Citral
- Physical state: clear liquid
- Supplier: Bedoukian Research
- Lot/batch No.: H116-1
- Composition of test material: 1.2% citral in 1:3 EtOH:DEP with 0.2% tocopherol
- Storage condition of test material: protected from light, kept refrigerated and brought to room temperature prior to application to patches
no further data given

Method

Type of population:
general
Subjects:
- Number of subjects inducted: 123 (36 male, 87 female)
- Number of subjects completed the test: 101 (36 male, 87 female)
- 22 subjects discontinued due to personal reasons, not due to test material reaction.
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 on this RIPT.
Controls:
1:3 ethanol:diethyl phthalate (EtOH:DEP) and saline were tested individually at the same time and in the same manner as the test material and used for control/comparision.
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 System)
- 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
- = no reading
N9R = No 9th reading

Results and discussion

Results of examinations:
Test material 1.2% citral in 1:3 EtOH:DEP with 0.2% tocopherol:
During the induction phase, one subject exhibited a low-level, transient (±/1) reaction.
At the challenge, one subject exhibited a low-level, transient (±) reaction.

Control material saline:
During the induction phase, five subjects exhibited a low-level, transient (±/1) reactions.
At the challenge, no reaction were exhibited.

Control material 1:3 EtOH:DEP:
During the induction phase, no reaction were exhibited.
At the challenge, no reaction were exhibited.

Conclusion:
ln this Repeated Insult Patch Test, citral, saline and 1:3 ethanol:diethyl phthalate did not induce dermal sensitization in human subjects.

Any other information on results incl. tables

Subjects #002 and #003 returned at the C1 visit without their patches on; they were re-patched at the C2 visit. Subjects #002, #003 and #070 missed the C4 visit.

Applicant's summary and conclusion