p-toluidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-toluidine

EC Number:

203-403-1

EC Name:

p-toluidine

Cas Number:

106-49-0

Molecular formula:

C7H9N

IUPAC Name:

4-methylaniline

Details on test material:

- Name of test material (as cited in study report): p-toluidine
- Physical state: solid (crystalline form)
- Analytical purity: >99%
- Lot/batch No.: GGHA 405

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 3.9-4.1 kg
- Housing: animals were caged individually in air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°
- Humidity (%): 50 ± 29
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, 72 hours, and 7, and 14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline phisiological solution
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize score system


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

One hour to 72 hours after exposure the conjunctivae of the animals showed slight to clear swellings with circa semiclosed lids and a clear hyperemiae of some vasculature until diffuse rich red colorations. The cornea of two animals showed diffuse areas of opacity. The iris of these animals was reddened. Additionally a clear and colourless discharge was observed.
From 24 hours after exposure the discharge had a white colour. Furthermore ablations of the conjunctivae and the nictitating membranes occurred to two animals 48 until 72 hours after the exposure. These animals also showed a white discolouration of the nictitating membranes.
Seven days after exposure the conjunctivae showed clear hyperemiae of some vasculature until diffuse carmine colours. One animal showed a slight swelling of the conjunctiva.
Fourteen days after exposure all animals were without irritations.

Any other information on results incl. tables

Time endpoint after application	24h			48h			72h			Average (24 -72 h )	Average (24 -72 h)	Average (24 -72 h)	Average (24 -72h) all animals
Animal number	1	2	3	1	2	3	1	2	3	1	2	3
Conjuctival Chemosis	2	2	2	1	2	2	1	1	1	1.3	1.7	1.7	1.6
Conjuctival redness	3	2	3	2	2	3	1	1	2	2.0	1.7	2.7	2.1
Iris	0	1	1	0	1	1	0	1	1	0.0	1.0	1.0	0.7
Corneal opacity	0	1	1	0	1	1	0	1	1	0.0	1.0	1.0	0.7
Fluorescein test	1	3	2				0	1	2	-	-	-	-

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information according to EU-GHS/CLP Criteria used for interpretation of results: EU

Executive summary:

Hofmann (1986)

In order to test the eye irritation potential of p-toluidine, 3 animals were tested according OECD 405 guideline test.

About 24 hours before the start of the investigation the treated eyes of research animals were analyzed for eventual damage of the cornea, after the instillation of one drop of fluorescein-sodium solution (0.01%).

100 mg of p-toluidine was applied in the conjunctival sac of one eye of each of 3 rabbits.

The observation of the eyes was performed 1, 24, 48, and 72 hours after the application of the test substance.

In addition at time points 24, 72 hours, and 7 and 14 days after the instillation of one drop fluorescein-sodium solution (0.01%), the cornea was examined under UV light in order to determine eventual damage.

One hour to 72 hours after exposure the conjunctivae of the animals showed slight to clear swellings with circa semiclosed lids and a clear hyperemiae of some vasculature until diffuse rich red colorations. The cornea of two animals showed diffuse areas of opacity. The iris of these animals was reddened. Additionally a clear and colourless discharge was observed.

From 24 hours after exposure the discharge had a white colour. Furthermore ablations of the conjunctivae and the nictitating membranes occurred to two animals 48 until 72 hours after the exposure. These animals also showed a white discolouration of the nictitating membranes.

Seven days after exposure the conjunctivae showed clear hyperemiae of some vasculature until diffuse carmine colours. One animal showed a slight swelling of the conjunctiva. Fourteen days after exposure all animals were without irritations.