Reaction mass of tridecanal and 2-methyldodecanal and pentadecanal and 2-methyltetradecanal

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2006-10-23 through 2006-12-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles. One concentration used during induction and challenge. Dose selection not justified.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Human Repeated Insult Patch Test (HRIPT)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

ICH Guideline for Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

2-methyldodecanal; 2-methyltetradecanal; pentadecanal; tridecanal

EC Number:

931-038-4

Molecular formula:

Not applicable - Multi constituent

IUPAC Name:

2-methyldodecanal; 2-methyltetradecanal; pentadecanal; tridecanal

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number: 115 qualified subjects (male and female)
- Number of participants completing the study: 104
- Age at study initiation: 17 to 78 yeras

Clinical history:

no data

Controls:

no

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: 3.6 cm²
- Vehicle / solvent: Diethylphthalate:Ethanol (3:1)
- Concentrations: 10%
- Volume applied: 0.2 mL per patch

No. of exposures: 9
- Exposure period: 3
- Site: dorsal skin
- Frequency of applications: 3/week
- Duration: 24 hours

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Site: naive site on the back
- Evaluation (hr after challenge): 24 and 72 hrs.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 104
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

No skin reaction was seen with the test material in a human patch test (0 reaction/104 participants).

Executive summary:

LINOLAL (i.e. N/i-C13/C15 aldehydes) was tested for its skin sensitisation potential in a human patch test (HPIRT) that was conducted under GCP conditions and according to current guidelines. Of the 115 qualified subjects aged 17 to 78 years who initially started, 104 participants completed the test. The other subjects discontinued their participation for various reasons, none of which were related to the application of the test material. During the Induction period participants received a patch with the test material on their back (0.2 mL test material; 10% in vehicle DEP:EtOH(3:1); occlusive patch, size 3.6cm². 3 patches/week, for 3 weeks). Approx. two weeks after the Induction phase, a Challenge patch was applied to a virgin test site following the same procedure as described above. The site was scored 24 and 72 after application.

There were no skin reactions in any of the participants, neither during the Induction phase nor after the Challenge. The test substance did not indicate a potential for skin irritation or allergic contact sensitisation under the test conditions (Consumer Product Testing Co., 2006).