3-nitrotoluene

Endpoint summary

Description of key information

Skin irriration/corrosion: not irritating (OECD 404, K1)

Eye irritation: not irritating (OECD 405 / EU B.5, K1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hochst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2.0-2.7 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas serve as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per plaster

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

Approximately 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal area of the body with an electric hair clipper on an area of about 25 cm². Only animals with intact skin were used.
On each animal was fixed an adhesive plaster with 2.5 x 2.5 cm cellulose layer on the prepared skin site. Under this plaster 0.5 mL of the undiluted substance was applied. Subsequently, the area was covered with a semiocclusive bandage.
The exposure time was 4 hours. After the exposure period, the remaining test substance was carefully removed from the skin with tepid tap water.
The assessments were made for 30-60 minutes and then at 24, 48, and 72 hours after the removal of the patch.
The erythema and eschar formation and edema ware evaluated numerically according to DRAIZE score method.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no erythema was reported

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no erythema was reported

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no erythema was reported

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was reported

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was reported

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema was reported

Irritant / corrosive response data:

During the complete test time, no irritation occurred.

Time after the patch Removal	24 h			48 h			72 h
Animal	1	2	3	1	2	3	1	2	3
Erythema andescharformation	0	0	0	0	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0

 

Interpretation of results:

not irritating

Executive summary:

Weigand (1986):

The skin irritation potential of 3-nitrotoluene was tested according to OECD guideline 404.

Approximately 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal area of the body with an electric hair clipper on an area of about 25 cm². Only animals with intact skin were used.

On each animal was fixed an adhesive plaster with 2.5 x 2.5 cm cellulose layer on the prepared skin site. Under this plaster 0.5 mL of the undiluted substance was applied. Subsequently, the area was covered with a semiocclusive bandage.

The exposure time was 4 hours. After the exposure period, the remaining test substance was carefully removed from the skin with tepid tap water.

The assessments were made for 30-60 minutes and then at 24, 48, and 72 hours after the removal of the patch.

The erythema and eschar formation and edema ware evaluated numerically according to DRAIZE score method.

During the complete test time, no irritation occurred.

On the basis of these results 3-nitrotoluene was considered not irritating to the skin.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

The skin irritation potential of 3-nitrotoluene was tested according to OECD guideline 404 (Weigand & Hofmann, 1986).

 

The exposure time was 4 hours. After the exposure period, the remaining test substance was carefully removed from the skin with tepid tap water. The assessments were made for 30-60 minutes and then at 24, 48, and 72 hours after the removal of the patch.

The erythema and eschar formation and edema ware evaluated numerically according to DRAIZE score method.

Mean (24/48/72 hrs) individual erythema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.

Mean (24/48/72 hrs) individual oedema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.

The test material is not a skin irritant under the test conditions.

 

Eye irritation: 

In a test according to OECD TG 405 (Weigand & Hofmann, 1986), 0.1 mL of 3-nitrotoluene was applied into the conjunctival sac of one eye of each of three rabbits.

Mean (24/48/72 hrs) individual conjunctiva / corneal opacity / iris / chemosis score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.

The test material is not an eye irritant under the test conditions.

 

Justification for classification or non-classification

Harmonised classification:

The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP). 

 

Self classification:

Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS. 

No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.