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Diss Factsheets

Administrative data

Description of key information

Skin irritation / corrosion

  • Rabbit: irritating (OECD 404, 4 h, occlusive) [BASF, 1982]

Eye irritation

  • Rabbit: irritating (OECD 405) [BASF, 1982]


Respiratory irritation

  • no valid study is available, but irritation of the respiratory tract/rhinitis was observed in an inhalation hazard test and a repeated dose study

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
yes
Remarks:
observation period (8 d)
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,6-Dimethylanilin
- Stability under test conditions: 3 months beyond the study period
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system 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
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
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:
0.33
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:
2.33
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
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d

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

2

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

0.33

 

2

1.33

0.67

3

2

2.33

4

2

2

5

1.33

1

6

2

2

Mean 24, 48, 72 h

1-6

1.61

1.39

 
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
2,6 -Xylidine is irritating to the skin (Cat. 2 according to GHS requirements).
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 (Cat. 2 according to GHS requirements).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12 May 1981
Deviations:
yes
Remarks:
observation period (8 d)
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2,6-Dimethylanilin
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 3.03 kg; females 2.92 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
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:
unspecified
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3 (one male, two females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal


SCORING SYSTEM: OECD Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details

Exposition:  unspecified              
Animal  Reading  Opacity Cornea area Iritis Redness Chemosis Discharge Symptoms
1 1 h 0 0 1 3 2 3 pupil constricted
2 1 h 0 0 1 3 2 3 pupil constricted
3 1 h 0 0 1 3 2 3 pupil constricted
1 24 h 1 4 0 2 1 0  
2 24 h 1 4 0 2 1 2 purulence
3 24 h 1 3 1 2 1 1  
1 48 h 1 4 0 2 1 0  
2 48 h 1 4 0 2 1 2 purulence
3 48 h 1 3 1 2 1 1  
1 72 h 1 4 1 2 1 1 pupil constricted
2 72 h 1 3 0 2 1 1 pupil constricted/purulence/ scar on the eyelid
3 72 h 1 2 1 2 1 1 pupil constricted/ scar on the eyelid 
1 8 d 0 0 0 1 0 0  
2 8 d 0 0 0 1 0 0 scar on the eyelid
3 8 d 0 0 0 0 0 0 scar on the eyelid
mean animal 1 24 - 72 h 1.00   0.33 2.00 1.00    
mean animal 2 24 - 72 h 1.00   0.00 2.00 1.00    
mean animal 3 24 - 72 h 1.00   1.00 2.00 1.00    
overall mean 24 - 72 h 1.00   0.44 2.00 1.00    
Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2A according to GHS requirements).
Executive summary:

The study was performed according to OECD 405. Three rabbits were exposed to 0.1 mL test substance; eyes were not washed out. The animals were observed for 8 d.

Slight corneal opacity, iritis and chemosis were completely reversible within 8 d. Moderate conjunctivae redness was not fully reversible in 2/3 animals within 8 d. However, a clear trend over time for decreasing effect strength was observable, and in 1/3 animals the redness was completely reversible. As additional effect, contracted pupils as reversible effect in all animals (a sign for iritis) and scars on the eyelid in 2/3 animals at the end of the observation period were observed. Since a observation period of 21 d was not exhausted as recommended in the actual guideline, the complete reversibility of the relevant conjunctivae redness can only be assumed.

Conclusion: Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2 according to GHS requirements).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

 There are valid in vivo data available for the assessment of the skin and eye irritation potential of 2,6-xylidine

 

Skin irritation / corrosion

A skin irritation/corrosion studyaccording to OECD 404 was performed under harsh occlusive conditions, as common in the early 1980s [BASF, 1982]. In total, six animals were exposed to ca. 0.5 mL test substance for 4 h before washing. The animals were observed for 8 days. 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.

 

Exposure for 1 hour under the same conditions also led to slight to moderate erythema and edema with scaling present on day 8 (end of observation period) [BASF, 1982].

 

In a second study performed according to OECD 404, three rabbits were exposed to the 0.5 mL of the unchanged test substance for 4 hours under semi-occlusive conditions [Hoechst, 1986]. Slight erythema was present in one animal which was fully reversible within 7 days. No signs of irritation were observed in the other tst animals.

 

Eye irritation

An eye irritation study was performed according to OECD 405 [BASF, 1982]. Three rabbits were exposed to 0.1 mL test substance; eyes were not washed out. The animals were observed for 8 d. Slight corneal opacity, iritis and chemosis were completely reversible within 8 d. Moderate conjunctivae redness was not fully reversible in 2/3 animals within 8 d. However, a clear trend over time for decreasing effect strength was observable, and in 1/3 animals the redness was completely reversible. As additional effect, contracted pupils as reversible effect in all animals (a sign for iritis) and scars on the eyelid in 2/3 animals at the end of the observation period were observed. Since a observation period of 21 d was not exhausted as recommended in the actual guideline, the complete reversibility of the relevant conjunctivae redness can only be assumed.

Conclusion: Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6-xylidine has to be considered as eye irritant.

 

In a second study performed according to OECD 405, three rabbits were exposed to the 0.1 mL of the test substance [Hoechst, 1986]. The treted eye was washed with physiological saline. Slight corneal opacity and chemosis as well as slight to moderate conjunctival redness were present 24 h - 72 h after instillation. All effects were fully reversible within 7 days.

Respiratory system

No valid data are available to judge the irritant capacity of the test substance on the respiratory tract. Due to the irritation of the respiratory tract/rhinitis observed in an IHT [BASF, 1982] and the results of a long-term feeding study (by evaporation of the test substance) a classification with STOT SE 3 may be warranted. Moreover, the testsubstance is legally classified as STOT SE 3.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is classified for skin irritation (Cat. 2) and eye irritation (Cat. 2) under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EU) No 2017/776.

Furthermore, 2,6 -xylidine is included in Annex VI of Regulation (EC) No. 1272/2008 with the following legal classification:

  • Skin irritation Cat. 2 (H315: causes skin irritation)
  • STOT Single Exp. 3 (H355: May cause respiratory irritation)