Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive conditions, 6 animals
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-Dimethylanilin
- Stability under test conditions: 3 months beyond the study period

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: males 2.62 kg; females 2.73 kg
- Housing: individually
- Diet (ca. 130g/ animal*d): Ovator Solikanin, Musaktor-Werke, Duesseldorf, D
- Water (ca. 250 mL/animal*d): tap water
- Acclimation period: ca. 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
6 (3 of each sex)
Details on study design:
TEST SITE
- Area of exposure: upper third of the back/ flank region


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water

SCORING SYSTEM: OECD Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed after 8 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Superficial necrosis was observed after 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Distinct necrosis was observed after 8 d
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: Scaling was observed after 8 d
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: Scaling was observed after 8 d
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: Scaling was observed after 8 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24-48-72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 d

Any other information on results incl. tables

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

4 h

1

1

1

erythema and edema exceeding area of application

2

1

2

erythema and edema exceeding area of application

3

2

3

erythema and edema exceeding area of application, haemorrhagia

4

2

2

erythema and edema exceeding area of application

5

2

2

erythema and edema exceeding area of application

6

2

2

erythema and edema exceeding area of application

24 h

1

1

1

erythema and edema exceeding area of application

2

1

2

erythema and edema exceeding area of application

3

2

3

erythema and edema exceeding area of application, haemorrhagia

4

2

2

erythema and edema exceeding area of application

5

2

1

erythema and edema exceeding area of application

6

2

2

erythema and edema exceeding area of application

48 h

1

1

0

 

2

1

0

 

3

2

2

erythema and edema exceeding area of application, haemorrhagia

4

2

2

erythema and edema exceeding area of application

5

1

1

erythema and edema exceeding area of application

6

2

2

erythema and edema exceeding area of application

72 h

1

1

0

 

2

1

0

 

3

2

2

erythema and edema exceeding area of application, haemorrhagia

4

2

2

erythema and edema exceeding area of application

5

1

1

erythema and edema exceeding area of application

6

2

2

erythema and edema exceeding area of application

8 d

1

0

0

desquamation

2

4

0

superficial necrosis

3

4

1

distinct necrosis

4

1

0

desquamation

5

1

0

desquamation

6

1

0

desquamation

Mean

24, 48, 72 h

1

1

1

 

2

1.33

0.67

3

2

1.67

4

2

2

5

1.33

1.33

6

2

1.67

Mean 24, 48, 72 h

1-6

1.61

1.41

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information
Executive summary:

The study was performed according to OECD 404 under harsh occlusive conditions as common in the early 1980s. In total six animals were exposed to ca. 0.5 mL test substance for 4 h before washing.

Distinct necrosis was observed in 1/6 animals after 8 d, superficial necrosis in another animal and scaling in all other animals. In the two animals with necrosis, very strong erythema was observed after 8 d. Three other animals showed questionable erythema and in one animal, erythema was reversible within 8 d. Slight to moderate edema were observed in all animals, which were fully reversible in 5/6 animals within at least 8 d. In the animal with the distinct necrosis, edema was not fully reversible.

The observation of a distinct necrosis indicates a skin destruction in full thickness as a sign for skin corrosion. However, the test was performed under harsh occlusive conditions and the results of the study should be considered as overpredictive.

Conclusion

2,6 -Xylidine is irritating to the skin (R38 according to EU requirements and Cat. 2 according to GHS requirements).