Tetrahydro-3-methylfuran

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12/17/85-12/19/85

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: comparable to a guideline study witha acceptable restrictions (e.g. non GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

Study conducted according to The United States Deprtment of Transportation Regulations

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydro-3-methylfuran

EC Number:

236-537-4

EC Name:

Tetrahydro-3-methylfuran

Cas Number:

13423-15-9

Molecular formula:

C5H10O

IUPAC Name:

tetrahydro-3-methylfuran

Details on test material:

Purity greater than 98%
Tetrahydrofuran listed as contaminant.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals were obtained from Buckshire Company and supplied food and water ad libitum. Rabbits were quarantined, weighed and observed for
general health for two weeks. Environmental conditions of the rooms were targeted for a temperature of 20 °C +/- 2 °C and relative humidity of 50 % +/- 10%. Excursions outside these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

24 and 48 hours after application

Number of animals:

6

Details on study design:

On the day prior to study initiation, the hair of 1 male and 5 female New Zealand White rabbits were closely clipped to expose the back from the scapular to the lumbar region. The rabbits weighed from 3146 to 4126 grams on the day of treatment. A 0.5 ml aliquot of 3-methyl-tetrahydrofuran was applied to test site beneath a 1-inch gauze square that was held in place with tape. The test site was then occluded with rubber sheeting for 4 hours, wiped with paper towels and scored according to the Draize scale. The adjacent areas of the untreated skin were used for comparison.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 4 to 48 hours

Score:

1

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 4 to 48 hours

Score:

1.5

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 4 to 48 hours

Score:

2.5

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 4

Time point:

other: 4 to 48 hours

Score:

4

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 5

Time point:

other: 4 to 48 hours

Score:

4

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 6

Time point:

other: 4 to 48 hours

Score:

4

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 4 to 48 hours

Score:

0.67

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 4 to 48 hours

Score:

2.33

Max. score:

3

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 4 to 48 hours

Score:

2.67

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 4

Time point:

other: 4 to 48 hours

Score:

3

Max. score:

4

Results 11

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 5

Time point:

other: 4 to 48 hours

Score:

3.33

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 6

Time point:

other: 4 to 48 hours

Score:

3

Max. score:

4

Any other information on results incl. tables

Erythema				Edema
Response	4 hr	24 hr	48 hr	4 hr	24 hr	48 hr
Severe	1 / 6; 2 / 6 (N); 1 / 6 (SN)	1 / 6 (N); 1 / 6 (SN,B); 1 / 6 (N, B)	1 / 6 (N); 1 / 6 (N, B)	4 / 6	0 / 6	0 / 6
Moderate	0 / 6	1 / 6	0 / 6	1 / 6	5 / 6	1 / 6
Mild	0 / 6	0 / 6	2 / 6, 1 / 6 (B)	0 / 6	0 / 6	2 / 6
Slight	2 / 6	2 / 6	1 / 6	1 / 6	1 / 6	2 / 6
No Response	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	1 / 6
N=Necrosis; SN=Superficial necrosis; B = Blanching;

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study 3 -methyl-tetrahydrofuran was a corrosive agent when applied to the clipped intact skin of rabbits.

Executive summary:

When 3-methyl-tetrahydrofuran (3-meTHhF; 0.5 ml) was placed onto the skin of clipped rabbits and left covered for 4 hrs and then wiped and covered with gauze, it produced slight erythema in 2 of 6 rabbits and severe erythema in 4 of the 6 rabbits; 2 rabbits also had necrosis and 1 had superficial necrosis within 4 hours post treatment. Slight to severe edema was observed in all rabbits at 4 hours. Approximately 24 hours post treatment, a total of 3 rabbits had severe erythema with necrosis or superficial necrosis. Slight or moderate edema was observed in all rabbits at 24 hours. At 48 hours, 4 rabbits had slight or mild erythema and 2 rabbits had severe erythema with necrosis; slight to moderate edema was observed in 5 rabbits. Blanching was observed in 2 rabbits at 24 and 48 hours post treatment. Under the conditions of this study 3 -meTHF was a corrosive agent when applied to the clipped intact skin of rabbits.