Nonan-4-olide

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

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:

publication

Title:

Unnamed

Year:

1979

Materials and methods

Type of study / information:

Skin irritation score

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

A panel of 50 adult male volunteers were dermally exposed to the test material, under a patch, for 48 h and then scored for irritation reactions.

GLP compliance:

not specified

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

Details on test material:

- Name of test material (as cited in study report): Gamma-nonalactone
- Analytical purity: >95 %
- Storage condition of test material: Kept in light-intercepting ampoules at 5 °C
- Stability under test conditions: No detectable changes in compositions were observed during the experiment.

Method

Details on study design:

- A panel of 50 adult male volunteers was dermally exposed to 0.05 mL of gamma-nonalactone (32 % in acetone) under a 15 mm lint patch.
- Individuals with known allergic reactions were excluded.
- Patches were placed in contact with the skin on the back of each subject and left for 48 h. The patches were then removed and the sites were swabbed with dry gauze to remove any residual test materials. 30 minutes later, the test sites were evaluated for dermal reactions. If necessary, 72, 96 and 120 h readings were performed.

- Scoring of patch test reactions:
-: negative reading
±: questionable erythema not covering the entire patch area
+: definite erythema of the entire patch area
++: erythema and edema
+++: erythema, edema, and vesicles (or papules)
++++: bullous reaction

Exposure assessment:

measured

Results and discussion

Results:

Gamma-nonalactone did not induce the skin irritation in human and the irritation score was 0.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, topical application of γ-nonalactone did not induce skin irritation in human.

Executive summary:

In a dermal irritation study, a panel of 50 adult male volunteers was dermally exposed to 0.05 mL of γ-nonalactone (32 % in acetone) under a 15 mm lint patch. Individuals with known allergic reactions were excluded. The patches were placed in contact with the skin on the back of each subject and left for 48 h. The patches were then removed and the sites were swabbed with dry gauze to remove any residual test materials. 30 minutes later, the test sites were evaluated for dermal reactions. If necessary, 72, 96 and 120 h readings were performed.

γ-nonalactone did not induce the skin irritation in human and the irritation score was 0.

Under the test conditions, topical application of γ-nonalactone did not induce skin irritation in human. This study was conducted according to a non-standard method and documentation was insufficient for assessment.

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