2(3H)-Furanone, dihydro-3-hydroxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

March 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Skin irritation was determined according to OECD Guideline 404 Acute Dermal Irritation / Corrosion.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxyoxolan-2-one

EC Number:

692-561-9

Cas Number:

19444-84-9

Molecular formula:

C4H6O3

IUPAC Name:

3-hydroxyoxolan-2-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

ANIMALS
-Number: three males.
-Strain and species: New Zealand White rabbits.
-Breeder: Hypharm, La Corbière, Roussay, France.
-Age/weight: at the beginning of the study, the animals were 2 to 4 months old and had a mean body weight of 2618 g (2526 g to 2707 g).
-Receipt: upon arrival at CIT, the animals were given a clinical examination to ensure that they are in good condition.
-Acclimation: the animals were acclimated to the study conditions for a period of 7 or 14 days before treatment.
-Selection: just before treatment, the skin of each animal (previously clipped) was examined in order to use only animals with healthy intact skin.
-Identification: the animals were individually identified with a metal ear-tag.

Environmental conditions :
-temperature : 18 ± 3°C,
-relative humidity : 50 ± 20% (see § Study plan adherence),
-light/dark cycle : 12 h/12 h (7:00 - 19:00),
-ventilation : approximately 12 cycles/hour of filtered, non-recycled air.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: During each exposure time, a dry gauze pad was applied to the opposite flank, in order to check that no alteration of the skin is induced by the semi-occlusive dressing and restraining bandage. The untreated flank acted as control.

Amount / concentration applied:

The test item was placed on a gauze pad, which was then applied to a skin area of approximately 6 cm2.
A dosage-volume of 0.5 mL/flank was used.

Duration of treatment / exposure:

Periods of 3 minutes, 1 hour and 4 hours

Observation period:

24, 48 and 72 hours after patch removal

Number of animals:

3 Males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Reversibility:

fully reversible

Irritant / corrosive response data:

No unscheduled deaths occurred during the study.
No clinical signs were noted in any animals.
After a 3-minute or a 1-hour exposure (animal 41), no erythema or edema were observed.
After a 4-hour exposure (three animals), a very slight erythema (grade 1) was noted in two animals at the one-hour time-point only.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. erythema: 0.0, 0.0, 0.0; showing no significant inflammation,
. edema: 0.0, 0.0, 0.0; showing no significant inflammation.

Applicant's summary and conclusion

Interpretation of results:

other: very slightly irritant

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test item, 2-Hydroxy Gamma Butyro Lactone, was very slightly irritant when applied topically to rabbits.
However, the test item is not classified as irritating to skin according to the criteria of CLP Regulation.