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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-nitrotoluene
EC Number:
202-728-6
EC Name:
3-nitrotoluene
Cas Number:
99-08-1
Molecular formula:
C7H7NO2
IUPAC Name:
1-methyl-3-nitrobenzene
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

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


Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
During the complete test time, no irritation occurred.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
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.