γ-valerolactone

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Literature searched from 1962 through 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Fragrance raw materials monographs: γ-VALEROLACTONE

Author:

Opdyke D.L.J.

Year:

1980

Bibliographic source:

Food Cosmet. T.

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:

- Principle of test: Modification of the maximization test with 25 human volunteers to imrove identification of moderate sensitizers
- Short description of test conditions: The test item was applied to the same site on the volar aspect of the forearms for five 48 hour periods. Following a ten day rest period, the subjects were challenged with a patch applied to a previously untreated site for 48 hours using an occlusive dressing.
- Parameters analysed / observed: Not specified.

Origial study from Kligman (1966), Kliman & Epstein (1975) and Kligman (1978)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

γ-valerolactone

EC Number:

203-569-5

EC Name:

γ-valerolactone

Cas Number:

108-29-2

Molecular formula:

C5H8O2

IUPAC Name:

5-methyloxolan-2-one

Specific details on test material used for the study:

No details given.

Method

Type of population:

other: Healthy adult black prisoners

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Age: 18-50 years
- Race: Black

Clinical history:

Not specified

Controls:

Control patch in provocative testing, consisting of 1 hour SLS exposure (2.5-10%), followed by 48 hour application of petrolatum.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: Patch test

ADMINISTRATION
- Site: Forearm or the lower leg in the calf region (induction), lower back (challenge)
- Type of application: Occlusive
- Description of patch: "occlusive dressing"
- Vehicle / solvent: Diethyl phthalate
- Concentrations: 10% of the test item in diethyl phthalate
- Volume applied: 1 mL (induction), 0.4 mL (challenge)
- Testing/scoring schedule: Five 48-hour periods for induction, then 10 days resting period, following challenge for 48 hours. Reactions were evaluated 72 and 96 hours after challenge.

EXAMINATIONS
- Grading/Scoring system: See "Any other information on material and methods incl. tables"

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Not specified, no indication of sensitisation observed.

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


RESULT OF CASE REPORT: The test item was found to be not sensitizing.