Carvacrol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database.

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

IFA GESTIS REPORT FOR THE TEST CHEMICAL

Author:

IFA GESTIS

Year:

2018

Bibliographic source:

GESTIS Substance Database

Reference 2

Reference Type:

other: Secondary Literature

Title:

TOXICOLOGICAL EVALUATION of the test chemical

Author:

BG Chemie

Year:

2000

Bibliographic source:

BG Chemie, 2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

An eye irritation study was conducted on 3 adult female albino rabbits in accordance with OECD guideline No. 405 to determine the relative local effects caused by the chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Thymol

EC Number:

201-944-8

EC Name:

Thymol

Cas Number:

89-83-8

Molecular formula:

C10H14O

IUPAC Name:

thymol

Details on test material:

- IUPAC Name: Thymol- InChI: 1S/C10H14O/c1-7(2)9-5-4-8(3)6-10(9)11/h4-7,11H,1-3H3- Smiles: c1(c(cc(C)cc1)O)C(C)C- Molecular formula :C10H14O- Molecular weight :150.2196 g/mol- Substance type:Organic- Physical state:Solid

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

- Weight at study initiation: 3.1 to 3.7 kg

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

100 μl (bulk weight approx. 60 mg)

Duration of treatment / exposure:

21 days

Observation period (in vivo):

1 hour after rinsing out the eyes and again after 24, 48 and 72 hours as well as 7, 14 and 21 days.

Number of animals or in vitro replicates:

3 female albino rabbits

Details on study design:

TEST SITE
- Area of exposure: the conjunctival sac of one eye
REMOVAL OF TEST SUBSTANCE
- Washing (if done): was rinsed out with physiological saline solution after 24 hours
- SCORING SYSTEM: According to the method of Draize, et al.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

21 d

Score:

> 2 - <= 2.3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

21 d

Score:

1

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

21 d

Score:

> 1.3 - <= 2.7

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Up to day 21 of the observation period all of the animals had positive fluorescein test results, and as of day 14 of the observation period, two rabbits developed pannus while the third showed swelling in the lower part of the eyeball.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The irritation scores were 2 to 2.3 for the conjunctivae, 1.0 for the iris and 1.3 to 2.7 for the cornea. Up to day 21 of the observation period all of the animals had positive fluorescein test results, and as of day 14 of the observation period, two rabbits developed pannus while the third showed swelling in the lower part of the eyeball. On the basis of these irreversible findings, the chemical was considered to be severely irritating to the eyes of treated rabbits.

Executive summary:

An eye irritation study was conducted on 3 adult female albino rabbits in accordance with OECD guideline No. 405 to determine the relative local effects caused by the chemical. Each animal had 100 μl (bulk weight approx. 60 mg) instilled into the conjunctival sac of one eye, which was rinsed out with physiological saline solution after 24 hours. The findings were scored in accordance with the Draize method 1 hour after rinsing out the eyes and again after 24, 48 and 72 hours as well as 7, 14 and 21 days. The irritation scores were 2 to 2.3 for the conjunctivae, 1.0 for the iris and 1.3 to 2.7 for the cornea. Up to day 21 of the observation period all of the animals had positive fluorescein test results, and as of day 14 of the observation period, two rabbits developed pannus while the third showed swelling in the lower part of the eyeball. On the basis of these irreversible findings, the chemical was considered to be severely irritating to the eyes of treated rabbits.