Methyl tetrahydro-2-furancarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5 July 1990 to 12 July 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to internation guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl tetrahydro-2-furancarboxylate

EC Number:

420-670-1

EC Name:

Methyl tetrahydro-2-furancarboxylate

Cas Number:

37443-42-8

Molecular formula:

C6H10O3

IUPAC Name:

methyl oxolane-3-carboxylate

Test material form:

other: liquid

Details on test material:

Label identification: Methyl Tetrahydrofuroate (METHFAT)
Source: QO Chemicals, Inc. 2801 Kent Avenue P.0. Box 2500 West Lafeyette, Indiana 47906
Date received: February 23, 1990
Lot number: PP17-9J29
Purity: Assume 100% for acute testing
Physical description: Clear colorless liquid.
Storage conditions: Sealed container at room temperature.
Test material preparation: A sufficient amount of neat test material was transferred from its original container to a labeled vial that contained a stir bar and was maintained on a magnetic stir plate prior to dispensation and throughout the dosing procedure.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Number on study: Three males and three females
Body Weight Range: 2290 and 2511 grams at study initiation
Age at start of Study: Young adult
Method of identification: Ear tag
Housing: Individual suspended mesh-bottom cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in accordance with standard operating procedures.
Quarantine: The animals were acclimated to laboratory conditions for a minimum of 6 days prior to study initiation.
Food and water: Purina® Certified Rabbit Chow® #5322 and tap water from on-site wells. Analysis of feed is performed and provided by the manufacturer. Water is analyzed twice yearly in accordance with S.O.P. No. A-Q20.
Environmental conditions: Animal room with controlled temperature (67-70° F), humidity (56-76%) and light (12 hours light/12 hours dark). There were approximately ten fresh air changes per hour.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The dose was 0.5 ml/site.

Duration of treatment / exposure:

4 hour

Observation period:

7 days

Number of animals:

One group of 6 rabbits.

Details on study design:

Test material preparation:
A sufficient amount of neat test material was transferred from its original container to a labeled vial that contained a stir bar and was maintained on a magnetic stir plate prior to dispensation and throughout the dosing procedure.

Method of test material administration:
On the day prior to dosing, the hair was removed from the backs of the rabbits using an Oster small animal clipper. Each 0.5 milliliter dose was applied under a secure 2- ply one inch square gauze patch that was overwrapped with a gauze binder that was secured with Dermiform®Tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.

Dose levels/group/treatment regimen:
The dose was 0.5 ml/site. There was one group of six rabbits, one intact site per rabbit. Each animal received a single, four-hour, semi-occluded exposure. At the end of four hours, the collars and bandages were removed and the sites wiped with wet disposable paper towels.

Mortality:
The rabbits were observed twice daily for mortality for the duration of the study.

Dermal Observations:
The application sites were observed for erythema, edema and other dermal findings at approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and daily thereafter through day 7 if irritation persisted. Dermal irritation was graded in accordance with the method of Draize. In order to facilitate dermal observations the rabbits were shaved approximately 1-2 hours prior to collecting the 72 hour dermal scores.

Body Weights:
Body weights were obtained and recorded on study day 0 (initiation) and at the time of each rabbit's termination from study.

Termination:
Upon termination from the study, the rabbits were sacrificed by intravenous overdose of anesthesia and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0 - 1

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test material induced very slight erythema on three of the six rabbits. There was no edema. Desquamation was present on one site on days 4-6. All erythema completely subsided by day 4 or earlier. There were no other dermal findings.

The Primary Irritation Index was calculated to be 0.3. The test material METHFAT received a descriptive rating classification of slightly irritating.

Other effects:

Mortality: None of the rabbits died.
Body weight: There were no significant body weight changes during the study period.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Primary Irritation Index was calculated to be 0.3. The test material, METHFAT, received a descriptive rating classification of slightly irritating.