4-nitrotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18.03. 1986 To 21.03.1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Reference 2

Reference Type:

secondary source

Title:

4-Nitrotoluene - CAS N°: 99-99-0 - SIDS Initial Assessment Report.

Author:

OECD

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-nitrotoluene

EC Number:

202-808-0

EC Name:

4-nitrotoluene

Cas Number:

99-99-0

Molecular formula:

C7H7NO2

IUPAC Name:

1-methyl-4-nitrobenzene

Details on test material:

- Name of test material (as cited in study report): p-nitrotoluene
- Physical state: solid (yellow-green crystal)
- Analytical purity: 99%
- Product number/code: GGBE 155
- Storage condition of test material: in the dark at 22°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-2.9 kg
- Housing: in air conditioned room, in single cage
- Diet (e.g. ad libitum): Altromin 2123 rabbit breeding diet (Altromin GmbH, Lage/Lippe) as well as hay ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from automatic drinking trough ad libitum


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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Polyethylene glycol 400

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg Test substance was moistened with 0.2 ml polyethylene glycol 400

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL Polyethylenglycol 400
- Lot/batch no. (if required): Ch-B 2322, Fa Riedel de Haen AG, Germany

Duration of treatment / exposure:

4 hour(s)

Observation period:

up to 72 hours

Number of animals:

3

Details on study design:

24 hours before start of the experiment rabbits were shaved at the dorsal region of the trunk (area 25 cm², intact skin). 500 mg test substance was moistened with 0.2 ml polyethylene glycol 400 and applied on a special tape with additional gauze (area: 2.5 cm²). This tape was fixed on the shaved area and covered by a semiocclusive dressing for 4 hours. After this time tape and test substance were carefully removed from the skin with lukewarm water. Reading were performed as follows: 30-60 min, 24, 48 and 72 hours after removing of the tape, according to DRAIZE score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Readings	24 h (after removal of the tape)			48 h (after removal of the tape)			72h (after removal of the tape)			Average animal 1 (24 -72 h)	Average animal 2 (24 -72 h)	Average animal 3 (24 -72 h)	Total average
Animals	1	2	3	1	2	3	1	2	3	1	2	3	-
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0
Odema	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Executive summary:

Hofmann (Hoechst AG, 1986)

 

4-Nitrotoluene, moistened with polyethylene glycol 400, was not irritating to the skin of rabbits, when applied under semi-occlusive condition for four hours according to OECD 404.

 

The mean Draize scores for edema and erythema were each "0".

 

4-Nitrotoluene is not irritating to the skin of rabbits.