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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non-GLP study performed according to a method similar to OECD Guideline 404. Limited details on test item provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-4-nitrobenzene
EC Number:
202-809-6
EC Name:
1-chloro-4-nitrobenzene
Cas Number:
100-00-5
Molecular formula:
C6H4ClNO2
IUPAC Name:
1-chloro-4-nitrobenzene
Details on test material:
- Name of test material (as cited in study report): p-Nitrochlorbenzol
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop, Meerbusch, Germany
- Weight at study initiation: 2.9 kg
- Diet (e.g. ad libitum): Mümmel Z, Ssniff, Soest, Germany
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18 °C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
24 hour(s)
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: a 2.5 x2.5 cm area
- Gauze pads were loaded with 500mg 1-chloro-4 -nitrobenzene suspended with 1 or 2 drops of water
- Type of wrap if used: The test areas were covered occlusive with a layer of PVC-film (5 x 5 cm) and adhesive tape (Leukoflex)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- after 24 hours

OBSERVATION TIME POINTS
- reading times: 24,48 72 hours and day 8 post application, control-reading 48 hours and day 8 post appl. was not included in the evaluation

SCORING SYSTEM
According to: Code of Federal Regulations, Title 16, Section 1500.41

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
other: after 72 hours score 1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
other: after 72 hours score 1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days (score 1)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
after 8 days score 3
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
A 48-h reading was not performed. This deficiency was overcome by assuming that the 48-h score is identical to the 24-h score. Thus, the average score per endpoint was calculated as follows (intact skin only):
reading: erythema: 0.0 (0 in all animals at all times) reading: oedema:   1.8

Based on the 24-72 h readings, no classification is necessary.

Any other information on results incl. tables

Erythema

 

Skin irritation / Animal No.

Total

Mean

Time

1

2

3

4

5

6

Intact skin

24h

72h

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

8d

0

0

0

0

0

0

 

 

Scarified skin

24h

72h

0

0

0

0

0

0

0

0

1

0

0

0

1

0

0.17

0

8d

0

0

0

0

0

0

 

 

Oedema

 

Skin irritation / Animal No.

Total

Mean

Time

1

2

3

4

5

6

Intact skin

24h

72h

2

0

2

1

2

2

2

0

2

2

3

1

13

6

2.17

1.0

8d

1

1

2

1

3

1

 

 

Scarified skin

24h

72h

2

0

2

1

2

2

0

0

2

2

2

1

10

6

1.67

1.0

8d

1

2

1

1

3

2

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classification:
DSD: not classified
EU-GHS: not classified
Executive summary:

Schreiber (Bayer AG), 1980

The skin irritation potential of 1 -chloro-4 -nitrobenzene was investigated in 6 New Zealand White rabbits conducted comparable to OECD-guideline 404.

A 2.5 x 2.5 cm area of intact shaved animal skin and scarified skin was used to apply the test substance. Gauze pads were loaded with 500 mg 1-chloro-4-nitrobenzene suspended with 1 or 2 drops of water. The test areas were covered occlusive with a layer of PVC-film (5 x 5 cm) and adhesive tape (Leukoflex). The exposure duration was 24 hours. The reading times were 24, 72 hours and 8 days after application. Day 8 post application was not included in the evaluation. The mean erythema scores at 24, 72 hours and 8 days were 0.0 in all animals in intact skin. The mean oedema score at the 24 hour reading point was 2.17 and at 72 hours 1.0. The criteria for classification are not fulfilled.