cis-2-tert-butylcyclohexyl acetate

Sensitisation data (human)

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-conducted and documented study with human volunteers, some restrictions in design, but contributing to the weight of evidence.

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

Principles of method if other than guideline:

Occlusive patches with the test material were applied to the same site of 112 volunteers on Monday, Wednesday and Friday for a total of 9 applications. The sites were graded for dermal irritation and sensitization 24 hours after the patch removals on Tuesday and Thursday and 48 hours after the patch removals on Saturday. Following approximately 2 weeks rest period, the challenge patches were applied to previously untreated test sites. After 24 hours the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

cis-2-tert-butylcyclohexyl acetate

EC Number:

243-718-1

EC Name:

cis-2-tert-butylcyclohexyl acetate

Cas Number:

20298-69-5

Molecular formula:

C12H22O2

IUPAC Name:

2-tert-butylcyclohexyl acetate

Test material form:

liquid

Details on test material:

Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 112 (101 completed the study)
- Sex: 19 males, 93 females
- Age: 18-70

Clinical history:

No individuals were impaneled if they exhibited or had a history of acute or chronic dermatologic, medical, or physical conditions that could interfere with dermal scoring. Subjects with any visible or known pre-existing skin diseases which might be confused with a skin reaction from the test material, or which may be reasonably expected to affect the outcome of the study were excluded from participation. This includes subjects with psoriasis or active eczema, even if currently controlled through medication. No subject was using sympathomimetics, antihistamines, non-steroidal anti-inflammatory agents, or corticosteroids during the study period. No known pregnant or lactating women were impaneled in the study.

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: Occlusive Strip with Flexcon (TruMed Technologies Inc., Burnsville, Minnesota).
- Concentrations: 10%
- Testing/scoring schedule: 9 total applications on Monday, Wednesday and Friday; scoring on Tuesday, Thursday and Monday. After a 2-week rest period, the challenge application for 24 hours, with scoring 24, 48 and 72 hours post-application.

EXAMINATIONS
- Grading/Scoring system:
0: no visible skin reaction
±: Barely perceptible erythema (minimal)
1+: Mild erythema (diffuse)
2+: Well defined erythema
3+: Erythema and edema
4+: Erythema and edema with vesiculation

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: only one subject had a score ± (barely perceptible erythema (minimal)) after the 5th application. The scores of all other subjects were 0 at all time. The scores after challenge were 0 for all subjects at all time points (24, 48 and 72 hours).
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 101
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

The substance as 10% solution did not elicit skin reactions in the repeated insult patch test with 101 human volunteers.

Executive summary:

The skin sensitizing properties of Verdox as 10% solution were tested in the human repeated insult patch test (HRIPT) with 101 human volunteers (112 volunteers were initially enrolled, but 11 dropped out due to reasons unrelated to the test substance applications). The occlusive patches with the test substance were applied for 24 hours on Monday, Wednesday and Friday for 9 consecutive applications. After ca. 2 weeks resting period, the subjects were challenged at previously untreated site with an occlusive 24 -hour application of the test substance, and the skin reactions were scored 24, 48 and 72 hours post-application. Only one subject had a barely perceptiple erythema in the induction phase after the 5th application. The scores for all subjects in the challenge phase were 0 at all time points. It is concluded that 10% solution of Verdox is not sensitizing to human skin.