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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study following a method equivalent to a recognised guideline; limited test material characeterisation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

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:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: at least 8 weeks old.
- Weight at study initiation: not reported
- Housing: The animals were housed 2/cage in suspended wire mesh cages.
- Diet: Rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5ml test material was applied.

Duration of treatment / exposure:

24 hours.

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: The fur was clipped from the backs and sides of the animals. The back to the left of the spinal column of all animals was abraded. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding. The back to the right of the spinal column remained intact.
- % coverage: not reported
- Type of wrap if used: trunks were wrapped with impervious material.

SCORING SYSTEM: Draize scoring system was used.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72h

Score:

1.13

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Very slight to well defined erythema was noted at 24 hours. Very slight edema was also noted at 24 hours. By 72 hours, all dermal scores were essentially zero.

Any other information on results incl. tables

Table 1. Skin reactions (using Draize scoring method)

Erythema & Eschar Formation	Hours	Rabbit number						Mean score
		1	2	3	4	5	6
Intact skin	24	1	2	1	1	1	1	1.17
	72	0	0	0	0	0	0	0
Abraded skin	24	1	1	2	2	1	1	1.5
	72	0	0	0	1	0	0	0.17
Edema
Intact skin	24	1	1	1	1	0	1	0.83
	72	0	0	0	0	0	0	0
Abraded skin	24	1	1	1	1	0	1	0.83
	72	0	0	0	0	0	0	0
Sum of mean scores								4.5
Primary irritation index = sum of mean scores/4								1.13

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test material is not considered to be irritating to the skin of New Zealand White rabits.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The study was performed pre-GLP and followed a method similar to OECD 404 guideline. The test substance was evaluated in 6 New Zealand white rabbits. A dose of 0.5 ml test substance (undiluted), was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. Very slight to well defined erythema was noted at 24 hours. Very slight edema was also noted at 24 hours. By 72 hours, all dermal scores were essentially zero. The test material produced a mean primary irritation index (PII) of 1.13 and is considered to be non-irritating to skin.