Carvacrol

Endpoint summary

Description of key information

Skin irritation/corrosion: Corrosive (OECD 404/GLP)

Serious eye damage/eye irritation: Not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

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

Species:

rabbit

Strain:

not specified

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

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

24 h

Score:

4

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

48 h

Score:

4

Irritation parameter:

erythema score

Basis:

other: Animals 1-4

Time point:

72 h

Score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Irritation parameter:

edema score

Basis:

other: Animals 3-4

Time point:

24 h

Score:

2

Irritation parameter:

edema score

Basis:

other: Animals 1-4

Time point:

48 h

Score:

0

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

There is an in vivo skin irritation study in rabbits available and a supporting publication from the ECVAM in vitro skin corrosivity validation study.

In a primary dermal irritation key study (ECETOC, 1995), 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. In this study, Carvacrol is corrosive to the skin based on the following mean values (24, 48 and 72 hr readings):

Erythema for all animals: 4

Edema for animal 1: 0.33

Edema for animal 2: 0

Edema for animal 3: 0.66

Edema for animal 4: 0.66.

Carvacrol was one of 60 chemicals used in the ECVAM in vitro skin corrosivity validation study (Barrett, 1998). The data was compared to the existing in vivo data provided in the ECETOC TR066 (1995) report. The result of the in vitro validation study is indicated as corrosive (C) with UN Packing groups II/III. Under CLP, this is equivalent to Skin corrosion Category 1B/C. At worst case, Skin corrosion Category 1B will be chose.

The conclusion from these studies is acceptable to use in the human health risk assessment.

Eye damage/eye irritation

The study does not need to be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Carvacrol (CAS No. 499-75-2) is classified as Skin corrosive Category 1B at worst case and does not need to classified for serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.