Reaction mass of 1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 1-methyl-3-(4-methylpentyl)-3-cyclohexene-1-carboxaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 30, 1964 - May 08, 1964

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not a validated method for determining skin irritation or skin sensitisation, but provides reliable supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The method followed in this study was that of the repeated insult method approved by the Food and Drug Administration.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

266-314-7

EC Name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

66327-54-6

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-4-(4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Constituent 2

Reference substance name:

1-methyl-3-(4-methylpentyl)-3-Cyclohexene-1-carboxaldehyde

Cas Number:

693252-50-5

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-3-(4-methylpentyl)-3-Cyclohexene-1-carboxaldehyde

impurity 1

Reference substance name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, trans-

Cas Number:

76169-46-5

Molecular formula:

C14H26O

IUPAC Name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, trans-

impurity 2

Reference substance name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, cis-

Cas Number:

76169-45-4

Molecular formula:

C14H26O

IUPAC Name:

Cyclohexanecarboxaldehyde, 1-methyl-4-(4-methylpentyl)-, cis-

impurity 3

Reference substance name:

1-methyl-4-(4-methylpentylidene)cyclohexanecarbaldehyde

Molecular formula:

C14H24O

IUPAC Name:

1-methyl-4-(4-methylpentylidene)cyclohexanecarbaldehyde

impurity 4

Reference substance name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

257-942-2

EC Name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

52475-86-2

Molecular formula:

C14H22O

IUPAC Name:

1-Methyl-4-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde

impurity 5

Reference substance name:

1-methyl-3-(4-methylpentylidene)cyclohexanecarbaldehyde

Molecular formula:

C12H24O

IUPAC Name:

1-methyl-3-(4-methylpentylidene)cyclohexanecarbaldehyde

Specific details on test material used for the study:

Chemical A-7155 = Vernaldehyde

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- A total of 55 healthy male and female inmate volunteers were screened and 52 completed the experiment.
- ages varied from 16 to 67 years
- No person was accepeted who had active dermatologic conditions or other indicated illness

Clinical history:

No data

Route of administration:

dermal

Details on study design:

PRE-TEST:
In a pilot group with 10 subjects, the test material was applied in closed patch test to the medial surfaces of the left deltoid areas. 48 hours later, the patch was removed and te reading was recorded. 72 hour readings for possible delayed reactions were taken on the next day. When all the results were negative, it was considered safe to initiate the main study.

MAIN STUDY:
The procedure consists in the repeated application of closed patch tests with 0.5 mL of test material being applied to individual absorbent patch. The patch was then applied to the area to be tested in a consecutive order. The patch was then secured by means of overlying strips of adhesive tape which was then further sealed completely with additional overlying strips of similarly impervious tape. The patch was allowed to remain in situ for 48 hours and then removed, at which readings were recorded.
The initial site of application of the patch was the inner surface of the right deltoid area. When it was removed 48 hours after application, the next application was made to the inner surface of the left deltoid area. In turn, the next application was made to the upper portion of the right forearm and the following application to the volar surface of the upper portion of the left forearm. Upon completion of this cycle, a return to the inner surface of the right deltoid area was made. Subsequently, the cycle of rotation was continued until 10 similar test applications had been made.
Followed by a two week rest period after which the challenge test series was applied, to be removed for a 48 hour reading and a 72 hour reading for delayed reactions.

Results and discussion

Results of examinations:

No irritative reactions observed in any of the subjects during the sensitizing or challenge test phase.

Applicant's summary and conclusion

Conclusions:

Under the conditions of a repeated occlusive patch test procedure, the 2% test material 7155, produced no irritative reactions observed in any of the subjects during the sensitizing or challenge test phase.
Vernaldehyde produced no sensitisation reactions that were considered allergic in the volunteers tested