3-nitrotoluene

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: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

3-nitrotoluene

EC Number:

202-728-6

EC Name:

3-nitrotoluene

Cas Number:

99-08-1

Molecular formula:

C7H7NO2

IUPAC Name:

3-nitrotoluene

Details on test material:

- Name of test material (as cited in study report): m-Nitrotoluene
- Physical state: liquid (light yellow oil)
- Analytical purity: 99.5%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hochst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.8-3.7 kg
- Housing: animals were housed in individual cages in full air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen, Altromin GmbH, Lage/Lippe, Germany, ad libitum plus hey (about 15 g daily)
- Water (e.g. ad libitum): deionize, chlorinated water from automatic drinking trough

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


IN-LIFE DATES: From: 04.02.1986 To: 07.02.1986

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): 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

until 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiologic saline solution
- Time after start of exposure: at 24 hours after exposure, and at all the other time points. The washing was performed also when excretions were observed in the treated eyes and when the fluorescein test was performed on the cornea of the treated eyes.

SCORING SYSTEM: Draize score


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change in corneal opacity reported

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change in corneal opacity reported

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change in corneal opacity reported

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no change to iris score reported

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no change to iris score reported

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no change to iris score reported

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no change to conjunctivae score reported

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no change to conjunctivae score reported

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no change to conjunctivae score reported

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change to chemosis score reported

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change to chemosis score reported

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no change to chemosis score reported

Irritant / corrosive response data:

One hour after the application a significant hyperemia of some blood vessels occurred in all animals on the conjunctiva. In one animal this effect was accompanied by a clear discharge. 24 to 72 hours after application the animals do not show any effect.

Any other information on results incl. tables

Time endpoint after application	24h			48h			72h
Animal number	1	2	3	1	2	3	1	2	3
Conjuctiva: Chemosis	0	0	0	0	0	0	0	0	0
Conjuctiva: redness	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0
Corneal opacity	0	0	0	0	0	0	0	0	0
Fluorescein test	0	0	0				0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Executive summary:

Hofmann (1986):

In a test according to OECD TG 405, 0.1 mL of 3-nitrotoluene was applied into the conjunctival sac of one eye of each of three rabbits. One hour after the application a significant hyperemia of some blood vessels occurred in all animals on the conjunctiva. In one animal this effect was accompanied by a clear discharge. 24 to 72 hours after application the animals do not show any effect.

3-Nitrotoluene is not irritating to the eyes of rabbits.