Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1971

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study following a method similar to the Buehler method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

no

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one

EC Number:

251-201-7

EC Name:

Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one

Cas Number:

32764-98-0

Molecular formula:

C10H16O2

IUPAC Name:

tetrahydro-6-(3-pentenyl)-2H-pyran-2-one

Test material form:

not specified

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 300 - 414g
- Housing: in metal cages of the suspended type with wire mesh floors.
- Diet (e.g. ad libitum): pellet diet supplemented with vitamin C ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

propylene glycol

Induction 2

Concentration / amount:

10%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

propylene glycol

Challenge 2

Concentration / amount:

10%

No. of animals per dose:

11

Details on study design:

Prior to each application of the test material, the hair was close clipped from the inter-scapular region using electric clippers. The test material was applied, at a volume of 0. 1 ml on a half inch square of surgical gauze, to the clipped inter-scapular region of the guinea-pigs in each group. The treatment area was then covered with an impervious elastic bandage ("Elastoplast" backed with "Sleek" plaster). Contact with the skin was maintained for 24 hours, when the dressings were removed and the resulting dermal response evaluated. After an incubation period of two weeks, a final challenge dose was applled.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: not reported

Group:

test chemical

Dose level:

10% test material

No. with + reactions:

0

Total no. in group:

11

Remarks on result:

other: Reading: other: not reported. Group: test group. Dose level: 10% test material. No with. + reactions: 0.0. Total no. in groups: 11.0.

Any other information on results incl. tables

No reactions were observed in any test animal.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, the test material is not considered to be a skin sensitiser.

Executive summary:

The study was performed to assess the skin sensitisation potential of the test material in the Hartley strain guinea pigs following the buehler method. The study was performed pre-GLP and following a method similar to OECD Guideline 406. For the epicutaneous induction and challenge application, a concentration of 10% was used. A group of 11 test animals received induction doses by topical application. Prior to each application of the test material, the hair was close clipped from the inter-scapular region using electric clippers. The test material was applied, at a volume of 0. 1 ml on a half inch square of surgical gauze, to the clipped inter-scapular region of the guinea-pigs in each group. The gauze was covered with impervious adhesive tape. The dressings were left in place for 24 hours. The test animals were challenged two weeks after the epidermal induction application. None of the test animals exhibited a dermal reaction to the challenge application of the test materials. Based on these results, the test material is not considered to be a skin sensitizer in guinea pigs.