3,4-dihydrocoumarin

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Coumarin

EC Number:

202-086-7

EC Name:

Coumarin

Cas Number:

91-64-5

Molecular formula:

C9H6O2

IUPAC Name:

2H-chromen-2-one

Test material form:

solid: crystalline

Details on test material:

Standards for comparison: Diethyl phthalate, Cyclamen aldehyde, Geraniol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

10 New Zealand White rabbits, aged 9-12 weeks are used for each test. The whole dorsal surface is clipped 3-4 days before the test is due to start, and animals in the telogen phase of hair growth are selected.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

yes

Duration of treatment / exposure:

The test material and appropriate standards are applied to the clipped dorsum of rabbits for 4 hours under individual semi-occlusive patches,
the treated areas are wiped and examined for evidence of irritation.

Observation period:

72h

Number of animals:

8

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

0.33

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24h, 48h, 72h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24h, 48h, 72h

Score:

0

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24h, 48h, 72h

Score:

1.33

Results 7

Irritation parameter:

erythema score

Basis:

animal: #7

Time point:

other: 24h, 48h, 72h

Score:

4

Results 8

Irritation parameter:

erythema score

Basis:

animal: #8

Time point:

other: 24h, 48h, 72h

Score:

0.33

Results 9

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

0

Results 10

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

0.33

Results 11

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

0

Results 12

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24h, 48h, 72h

Score:

0

Results 13

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24h, 48h, 72h

Score:

0

Results 14

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24h, 48h, 72h

Score:

0.67

Results 15

Irritation parameter:

edema score

Basis:

animal: #7

Time point:

other: 24h, 48h, 72h

Score:

3.67

Results 16

Irritation parameter:

edema score

Basis:

animal: #8

Time point:

other: 24h, 48h, 72h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Only one animal shows mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal. Therefore, it's not classified as irritating.