Nonan-4-olide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1976

Rationale for reliability incl. deficiencies:

other: No data on ethical approval. Only 25 volunteers were tested, the concentration of the substance applied was not reported, no data on rest period

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Maximisation test on human

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Nonan-4-olide

EC Number:

203-219-1

EC Name:

Nonan-4-olide

Cas Number:

104-61-0

Molecular formula:

C9H16O2

IUPAC Name:

5-pentyloxolan-2-one

Constituent 2

Reference substance name:

5-pentyldihydrofuran-2(3H) -one

IUPAC Name:

5-pentyldihydrofuran-2(3H) -one

Details on test material:

- Name of test material (as cited in study report): #76-4-8 Aldehyde C-18
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Reception date: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Sex: 11 males and 14 female
- Age: 18-43 years
- Race: 21 whites, 4 blacks
- Demographic information: no data

Clinical history:

Healthy volunteers

Controls:

None

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: no data
- Vehicle / solvent: none
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule:
The material was applied to the same site on the volar forearm or back of all subjects for 5 alternate-day 48 hour periods .The patch site was pre-treated for 24 hours with 2.5 % aqueous sodium lauryl sulfate under occlusion.


EXAMINATIONS
- The challenge site was read on removal of the patch and 24 hours thereafter.
- Grading/Scoring system: no data
- Statistical analysis: none

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

Under the conditions employed in this study, there was no evidence of sensitisation to γ-Nonalactone.

Executive summary:

A panel of 25 male and female human healthy adult volunteers participated in a maximization test in which γ-Nonalactone was applied to the volar forearm or the back of the subjects under occlusive patches. During the induction phase patch were applied for five alternate-day 48 hour periods. The patches were removed 24 hours after application. As γ-Nonalactone was not irritating in the pre-test, the patch site was pre-treated for 24 hours with 2.5 % aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours thereafter.

Under the conditions employed in this study, there was no evidence of sensitisation to γ-Nonalactone.