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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

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:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
EC Number:
915-617-9
Molecular formula:
C13H22O2
IUPAC Name:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
Test material form:
liquid

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 photo allergy 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: oedema

Results and discussion

Results of examinations:
SYMPTOMS
Test substance: During the induction phase, one of the subjects exhibited a 1-level plus oedema 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 oedema 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

Conclusions:
The substance is not a skin sensitiser in the assay conducted involving 235 volunteers.
Executive summary:

In the assay conducted by Harrison Research Laboratories, Inc. (2003), 235 volunteers (63 males, 172 females, aged from 18 to 70 years) 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. 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. The test substance was applied as a 5.3 % solution in 75 % DEP:25 % ethanol. Vehicle control and normal saline were used as negative controls. 201 subjects completed the study. The applied amount of the test substance corresponded to a total dose of 4000 μg/cm2. During the induction phase, one of the subjects exhibited a 1-level plus oedema reaction; the test site was changed. Other subjects exhibited low-level, transient (±/1) reactions. At the challenge, low-level, transient (±) reactions were exhibited. Low-level, transient reactions (±/1) were also observed in several subjects upon exposure to control substances.