Thymol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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 publication.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Final Report on the Safety Assessment of test chemical

Author:

COSMETIC INGREDIENT REVIEW

Year:

2006

Bibliographic source:

International Journal of Toxicology

Reference 2

Reference Type:

other: authoritative database

Title:

Acute toxicity - test chemical

Author:

IFA GESTIS

Year:

2018

Bibliographic source:

GESTIS database

Reference 3

Reference Type:

other: authoritative database

Title:

Acute toxicity : Test Chemical

Author:

U.S. National Library of Medicine

Year:

2015

Bibliographic source:

HSDB

Reference 4

Reference Type:

secondary source

Title:

Test substance used to determine acute toxicity

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

TOXNET

Reference 5

Reference Type:

secondary source

Title:

Conclusion on the peer review of the pesticide risk assessment of the active substance

Author:

EFSA

Year:

2012

Bibliographic source:

EFSA Journal

Reference 6

Reference Type:

secondary source

Title:

Test chemical: Reregistration Eligibility Decision (RED)

Author:

U. S. Environmental Protection Agency (EPA)

Year:

1993

Bibliographic source:

U. S. Environmental Protection Agency (EPA)

Reference 7

Reference Type:

secondary source

Title:

DAR - test chemical

Author:

European Food Safety Agency (EFSA)

Year:

2011

Bibliographic source:

European Food Safety Agency

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute dermal toxicity of Thymol (CAS no: 89-83-8) in rabbit.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

yes

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:

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

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, white crystalline powder, thyme-like, aromatic odor

Specific details on test material used for the study:

- 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, white crystalline powder, thyme-like, aromatic odor

Test animals

Species:

rabbit

Strain:

other: New Zealand rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: weighing 1.9 to 2.4 kg

Administration / exposure

Type of coverage:

open

Vehicle:

not specified

Details on dermal exposure:

TEST SITE - Area of exposure: clipped abraded abdominal skin

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days - Frequency of observations and weighing: Observations were made for mortality and toxic effects for 7 days, which was followed by gross necropsy.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at 2000 mg/kg bw

Clinical signs:

other: At 24 h, rabbits had moderate erythema (10 of 10 rabbits), moderate edema (8 of 10 rabbits), or slight edema (2 of 10 rabbits). On day 7, moderate erythema was observed in 3 of 10 animals and slight erythema was noted in 4 of 10 animals.

Gross pathology:

not specified

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal LD50 value was considered to be >2000 mg/kg bw, when 10 male and female New Zealand rabbits were treated with Thymol (CAS no: 89-83-8) by dermal application to the clipped abraded abdominal skin.

Executive summary:

Acute dermal toxicity study of Thymol (CAS no: 89-83-8) was conducted in 10 male and female New Zealand rabbits at the dose concentration of 2000 mg/kg bw, to the clipped abraded abdominal skin.Observations were made for mortality and toxic effects for 7 days, which was followed by gross necropsy.No mortality was observed at 2000 mg/kg bw. At 24 h, rabbits had moderate erythema (10 of 10 rabbits), moderate edema (8 of 10 rabbits), or slight edema (2 of 10 rabbits). On day 7, moderate erythema was observed in 3 of 10 animals and slight erythema was noted in 4 of 10 animals. Hence LD50 value wasconsidered to be >2000 mg/kg bw, when10 male and female New Zealand rabbits were treated with Thymol (CAS no: 89-83-8) by dermal application to the clipped abraded abdominal skin.