Registration Dossier

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-conducted and documented study with human volunteers, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
235 volunteers were challenged occlusively with 0.3 mL of the test material for 24 hours on Monday, Wednesday and Friday, for 3 consecutive weeks, for a total of 9 applications. The applied amount of the test substance corresponded to a total dose of 4000 μg/cm2. After a ca. 2 weeks rest period they were challenged at a virgin site for 24 hours and reactions were scored immediately after the patch removal, 24, 48 and 72 hours later.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
EC Number:
915-617-9
Molecular formula:
C13H22O2
IUPAC Name:
Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): H188-1
- Physical state: clear liquid
- Storage condition of test material: refrigerated, protected from light

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 235 (201 completed the study)
- Sex: 63 males, 172 females (54 males and 147 females completed the study)
- Age: 18 to 70 years
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 appropriate clearance period had elapsed since a subject was patched on a repeated insult patch test or a photoallergy test before being used in this assay.
Controls:
Vehicle control (75% DEP:25% ethanol) and normal saline were used as negative controls.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch:
- Vehicle / solvent: 75% DEP : 25% ethanol
- Concentrations: 5.3%.
- Volume applied: 0.3 mL
- Testing/scoring schedule: induction phase: 24 hours on Monday, Wednesday and Friday, 3 consecutive weeks, a total of 9 applications; scoring before the new patch application. Challenge phase: single 24 hours application at a virgin site, scored immediately after the patch removal, 24, 48 and 72 hr later.
- Removal of test substance: on Tuesdays and Thursdays by technicians; on Saturdays by subjects themselves.

EXAMINATIONS
- Grading/Scoring system:
0: no visible reaction
±: faint, minimal erythema
1: erythema
2: intense erythema, induration
3: intense erythema, induration, vesicles
4: severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E: edema

Results and discussion

Results of examinations:
SYMPTOMS
Lyral: During the induction phase, one of the subjects exhibited a 1-level plus edema reaction; the test site was changed. Other subjects exhibited low-level, transient (±/1) reactions. At the challenge, low-level, transient (±) reactions were exhibited.
Saline: during the induction phase, 2 subjects exhibited low-level, transient reactions (±/1). At the challenge, three subjects exhibited low level, transient (±/1) reactions.
Vehicle control: during the induction phase, one subject exhibited a 1-level plus edema reaction; the test site was changed. The new test site exhibited no reaction. Other subjects exhibited low-level, transient (±/1) reactions. At the challenge, low-level, transient (±) reactions were exhibited.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 201
- Number of subjects with equivocal reactions: 0

Applicant's summary and conclusion