4,4'-methylenedi-o-toluidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study comparable to guideline with acceptable restrictions (reduced reporting)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Approximately 0.1 g of the test substance was applied to the conjuntival sac of two white Vienna rabbits. The other eye treated with physiological saline served as a control. Substance was not washed out and reading was performed 10 min, 1, 3, and 24, and 48 hours after instillation of the test substance. Scores given for ocular reactions were compatible to the Draize criteria.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-methylenedi-o-toluidine

EC Number:

212-658-8

EC Name:

4,4'-methylenedi-o-toluidine

Cas Number:

838-88-0

Molecular formula:

C15H18N2

IUPAC Name:

4-[(4-amino-3-methylphenyl)methyl]-2-methylaniline

Details on test material:

- Name of test material (as cited in study report): 4,4´-Diamino-3,3´-dimethyl-diphenylmethan = o-"Toluidinbase", destilled, grinded
- Physical state: crystalline powder, creme-like coloured
- Analytical purity: 99-100%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one drop of saline into the other eye

Amount / concentration applied:

Amount applied: 100 mg

Duration of treatment / exposure:

single application

Observation period (in vivo):

2 days

Number of animals or in vitro replicates:

2

Details on study design:

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

SCORING SYSTEM: Descriptive scores were converted into Draize scores

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48 h

Score:

0

Max. score:

3

Remarks on result:

other: slight erythema (score 1) observed on readings 10 min to 3 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Slight, barely perceptible erythema was observed at observation times <24 hours. Ocular reaction reversed completely within 24 hours after instillation of the test substance.