Carbazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guideline study, but methodological deficiency in dosing procedure

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission, USA; Code of Federal Regulations, Title 16, Section 1500.42

Principles of method if other than guideline:

The method used is similar to the OECD test guideline 405 (Acute Eye Irritation/Corrosion) with some deviations (application of 0.1 mL of test substance as 10% suspension in 0.5% carboxymethyl cellulose, first observation 24 h after application)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Carbazole

EC Number:

201-696-0

EC Name:

Carbazole

Cas Number:

86-74-8

Molecular formula:

C12H9N

IUPAC Name:

9H-carbazole

Details on test material:

- Name of test material (as cited in study report): Produkt 110 804 received from Rütgerswerke AG
- No further information on test material

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

other: carboxymethyl cellulose

Controls:

other: second eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10 % test substance suspension in 0.5% carboxymethyl cellulose

VEHICLE
- Concentration (if solution): ~ 90 %

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: according to Draize (ETAD recommendation)SCORING SYSTEM:
Draize numerical scoring system for grading ocular irritation effects adopted by ETAD
(Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics,
published by Food and Drug Officials USA 1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 h

Score:

4

Max. score:

110

Reversibility:

not fully reversible within: 7 d

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.83

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 1 d

Any other information on results incl. tables

Individual scores (according to Draize)

 

		Rabbit 1				Rabbit 2				Rabbit 3				Rabbit 4				Rabbit 5				Rabbit 6
Observation time (day)		1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
Cornea	Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Area	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae	Redness	1	0	0	0	1	1	1	1	1	0	0	1	2	1	1	0	1	1	1	0	1	1	1	1
	Chemosis	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
	Discharge	1	1	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 

Total score (according to Draize, summation over all rabbits)

 

Day	1	2	3	7
Total score	24	10	8	6

 

 

Following instillation of the test compound, none of the test animals showed any reaction of cornea and iris.

In all animals, redness of the conjunctivae was observed at 24 h. At day 7, redness was still seen in 3 animals (score 1). As no later observations were made, the complete reversibility of this effect is not verified.

Grade 1 chemosis developed in the eyes of two animals at 24 h but subsided until the following observation (day 2).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a primary eye irritation test with 6 rabbits, carbazole was shown not to be irritating after instillation of ca. 10 mg test substance suspended in 100 µL of 0.5 % carboxymethyl cellulose. Eye reactions were minor (only conjuctivae redness and chemosis, score 1 to 2) but redness had not completely disappeared at day 7, the latest observation time.