Indole

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:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth et.al

Year:

1962

Bibliographic source:

American Industrial Hygiene Association Journal, 1962

Reference 2

Reference Type:

publication

Title:

Fragrance raw materials monographs

Author:

D.L.J. Opdyke

Year:

1974

Bibliographic source:

Food and Cosmetics Toxicology Volume 12, Issues 7–8, December 1974, Page 915

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Primary skin irritation study was performed on rabbits for the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Indole

EC Number:

204-420-7

EC Name:

Indole

Cas Number:

120-72-9

Molecular formula:

C8H7N

IUPAC Name:

1H-indole

Test material form:

solid

Details on test material:

Name: Indole
IUPAC Name: 1H-Indole
Molecular Formula: C8H7N
Molecular Weight: 117.15 g/mol
SMILES: c1ccc2[nH]ccc2c1
Substance Type: Organic
Physical State: Solid

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.01 ml of undiluted sampl

Duration of treatment / exposure:

24 hours

Observation period:

24, 72 hours

Number of animals:

five albino rabbits

Details on study design:

TEST SITE
- Area of exposure: clipped skin of uncovered rabbit belly
- % coverage:
- Type of wrap if used: not used

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) :
SCORING SYSTEM:
- Method of calculation: Reactions observed were graded on 10-grade ordinal series and was based upon the severest reaction on clipped uncovered rabbit belly. On a scale of 1-10, Grade 1 indicated no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicated necrosis when undiluted and Grade 10 indicated necrosis from a 0.01% solution.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

10

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test chemical was reported as not irritating to the uncovered rabbit belly with a score of 1.

Any other information on results incl. tables

Primary skin irritation study:

CAS	Grades
120-72-9	1

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test chemical was reported as not irritating to the uncovered rabbit belly with a score of 1.

Executive summary:

Primary skin irritation study was performed on rabbits for the test chemical. 0.01 ml of undiluted test chemical was applied to the clipped skin of 5 albino rabbits for 24 hours. The application site was left uncovered. Reactions observed were graded on 10-grade ordinal series and was based upon the severest reaction on clipped uncovered rabbit belly. On a scale of 1-10, Grade 1 indicated no irritation and Grade 2 the least visible capillary injection from the undiluted chemical. Grade 6 indicated necrosis when undiluted and Grade 10 indicated necrosis from a 0.01% solution.The test chemical  was reported as not irritating to the uncovered rabbit belly with a score of 1.