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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979
Reference Type:
publication
Title:
o-TOLUIDINE CAS No: 95-53-4 SIDS Initial Assessment Report.
Author:
OECD SIDS
Year:
2006
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize Test according Fed. Reg, 38, No,187, §1500.41, p. 27029 (1973/sept./ 27)
Principles of method if other than guideline:
Draize Test according Fed. Reg, 38, No,187, §1500.41, p. 27029 (1973/sept./ 27)
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): o-toluidine
- Analytical purity: 99.5%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Age at study initiation: male: 3.1kg, 2.88kg, 2.71kg; female: 2.94 kg, 2.79kg, 3.17kg



Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Undiluted o-Toluidine was applied on a cotton pad (2.5cmx2.5cm) for application on the skin
Duration of treatment / exposure:
24 hour(s)
Observation period:
After application of patch: 24h, 48h, 72h and 7 days and 8 days
Number of animals:
6
Details on study design:
Each animal received two applications of the test material. One on the intact skin of the right flank and the other one on the scarified skin of the left flank. 24h, post application, the skin of the animals were washed with water. The assessment of the dermal changes was based on the OECD Draize scoring method. Moreover, the animals were observed for mortality and clinical signs of toxicity

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
with 8 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24h, 48h, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24h, 48h, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24h, 48h, 72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24h, 48h, 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24h, 48h, 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 8 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24h, 48h, 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The treatment led to slight or moderate erythema and moderate edema in 5/6 animals up to 72h and 24h after start of the application, respectively. At 72 h after application, the same five animals exhibited scaling, which persisted till day 8 of the study. Necrosis (soft, parchment like or leathery) was observed in one animal till the termination of the study. The clinical finding of the necrosis was confirmed by macroscopic pathology.

Other effects:
Systematic Toxicity: No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure

Any other information on results incl. tables

Scoring Method used: OECD Draize scores

Time (hrs)

Individual scoring

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

Erythema

24 h

2

2

4

2

2

2

48 h

2

2

4

2

2

2

72 h

2

1

4

1

1

1

mean

2

1.66

4

1.66

1.66

1.66

Edema

24 h

2

2

2

2

2

2

48 h

2

2

2

2

2

2

72 h

0

0

2*

0

0

0

mean

1.33

1.33

2

1.33

1.33

1.33

Time (hrs)

Individual scoring

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

Erythema

 

8 days

0

0

4

0

0

0

 

Edema

 

8 days

0

0

2*

0

0

0

 

*= signs extends beyond the area of exposure

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS-CLP
Executive summary:

BASF (1979)

Undiluted o-toluidine was applied to the intact and to the scarified skin of the flank of rabbits under occlusive conditions (according to Fed. Reg, 38, No, 187, §1500.41, p. 27029). Following the 24-hour treatment time the treated area was washed with water. Slight to moderate erythema and moderate edema of the intact skin were observed for 72 hours. At 72 hours these animals exhibited scaling, which was still observed on day 8. Necrosis was observed in 1/6 animals (intact skin).

Overall, o-toluidine was evaluated as skin irritating.