Carvacrol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carvacrol

EC Number:

207-889-6

EC Name:

Carvacrol

Cas Number:

499-75-2

Molecular formula:

C10H14O

IUPAC Name:

2-methyl-5-(propan-2-yl)phenol

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
-Piurity: 100%
-Spec No.:3362701

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

other: intact skin

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hrs

Observation period:

7 days

Number of animals:

4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

24 h

Score:

4

Results 2

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

48 h

Score:

4

Results 3

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

72 h

Score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

other: Animals 3-4

Time point:

24 h

Score:

2

Results 7

Irritation parameter:

edema score

Basis:

other: Animals 1-4

Time point:

48 h

Score:

0

Results 8

Irritation parameter:

edema score

Basis:

other: Animals 1-4

Time point:

72 h

Score:

0

Irritant / corrosive response data:

In animal 1, severe erythema was evident from 24-72 hrs and was still present at 7 days. Severe edema was present at 1 hr but disappeared after 48 hrs. Eschar and hardened skin was noted from 24 hrs to day 7.
In animal 2, severe erythema was evident from 24-72 hrs and was still present at 7 days. Severe edema was present at 1 hr but disappeared after 24 hrs. Eschar and hardened skin was noted from 24 hrs to day 7.
In animal 3, severe erythema was evident from 24-72 hrs and was still present at 7 days. Moderate edema was present at 1 hr which decreased to slight edema at 24 hrs; it disappeared by 48 hrs. Eschar was noted at 24 hrs and eschar/hardened skin was noted from 48 hrs to 72 hrs. The animal was dead by day 7.
In animal 4, severe erythema was evident from 24-72 hrs and was still present at 7 days. Moderate edema was present at 1 hr which decreased to slight edeam at 24 hrs; it disappeared by 48 hrs. Eschar and hardened skin was noted from 48 hrs to day 7.

Applicant's summary and conclusion

Interpretation of results:

other: Corrosive

Conclusions:

In an in vivo rabbit skin irritation/corrosion study, carvacrol was corrosive.

Executive summary:

In a primary dermal irritation study (TR066), 4 female rabbits were dermally exposed (intact skin) to 0.5mL of Carvacrol (100%, undiluted) for 4 hours. Animals then were observed for 7 days after dosing. Irritation was scored by the method of Draize.

Carvacrol is corrosive based on the average scores calculated from the numerical values given to the irritation observed at the 24, 48 and 72 hour observations which were 4 for erythema and 0.4 for oedema.

This in vivo skin irritation/corrosion study in the rabbit is acceptable and satisfies the guideline requirement for an OECD 404 study.