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Diss Factsheets

Administrative data

Description of key information

Skin irritation


1,2 -dichloro-4-nitrobenzene was tested for skin irritation in rabbits in a study according to OECD Guideline 404. Following dermal application to the shaved, intact skin of 3 rabbits for 4 hours 1,2 -dichloro-4-nitrobenzene showed very slight erythema and edema (score 1) after 24 h. This was fully reversible within the next 24 h. Thus, the test item was evaluated as non-irritant (Hoechst AG 1988).


Eye irritation
1,2 -dichloro-4-nitrobenzene was tested for eye irritation in rabbits in a study according to OECD Guideline 405. The substance was applied into the conjunctival sac of the eye of rabbits caused slightly irritating effects which were reversible within 72 hours post application (Hoechst AG 1988). 

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:
other: Guideline study, GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.3 kg
- Diet ad libitum
- Water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
4 hour(s)
Observation period:
up to 72 hours post exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: gauze patch with plaster and fixed by a semiocclusive wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
scoring for erythema (maximum value possible: 4) // edema (maximum value possible: 4)
intact: 30-60 min-24 hrs-48 hrs-72 hrs - sum
rabbit 1: 2-1-0-0 - 0.3 // 1-0-0-0 -0
rabbit 2: 1-1-0-0 - 0.3 // 0-0-0-0 - 0
rabbit 3: 1-0-0-0 - 0 // 0-0-0-0 - 0

overall:
mean scores for erythema/scabbing: 0.2
mean scores for edema: 0.0
Other effects:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
Following dermal application to the shaved, intact skin of 3 rabbits for 4 hours 1,2 -dichloro-4-nitrobenzene was evaluated as non-irritant.
Executive summary:

1,2 -dichloro-4-nitrobenzene was tested for skin irritation in rabbits in a study according to OECD Guideline 404. Following dermal application to the shaved, intact skin of 3 rabbits for 4 hours 1,2 -dichloro-4-nitrobenzene showed very slight erythema and edema (score 1) after 24 h. This was fully reversible within the next 24 h. Thus, the test item was evaluated as non-irritant (Hoechst AG 1988).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
other: Guideline study, GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.5 kg
- Diet ad libitum
- Water ad libitum
- Acclimation period: 24 hours


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light):12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 100 mg/eye
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
up to 72 hours post exposure
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after exposure time
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.2
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
rabbit1/2/3, 1h-24 hrs-48 hrs-72 hrs - mean score:
-Cornea: 0/0/0-0/0/0-0/0/0-0/0/0 - 0 (max. possible: 4)
-Iris: 1/1/1-0/1/0-0/0/0-0/0/0 - 0.1 (max possible: 2)
-Conjunctivae (Redness): 2/2/3-2/3/2-1/2/2-0/0/0 - 1.3 (max. possible: 3)
-Conjunctivae (Chemosis): 2/2/2-0/1/1-0/0/0-0/0/0 - 0.2 (max. possible: 4)
Other effects:
discharge: all rabbits at 1 hour, rabbit 2 and 3 up to 24 hours post reading
REVERSIBILITY: within 72 hrs p.a.
Interpretation of results:
GHS criteria not met
Conclusions:
1,2 -dichloro-4-nitrobenzene applied into the conjunctival sac of the eye of rabbits caused slightly irritating effects which were reversible within 72 hours post application.
Executive summary:

1,2 -dichloro-4-nitrobenzene was tested for eye irritation in rabbits in a study according to OECD Guideline 405. The substance was applied into the conjunctival sac of the eye of rabbits caused slightly irritating effects which were reversible within 72 hours post application (Hoechst AG 1988).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the above discussed experimental results, the substance is not classified in accordance with Regulation (EC) No 1272/2008.