Registration Dossier
Registration Dossier
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EC number: 202-764-2 | CAS number: 99-54-7
Skin irritation / corrosion
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, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-dichloro-4-nitrobenzene
- EC Number:
- 202-764-2
- EC Name:
- 1,2-dichloro-4-nitrobenzene
- Cas Number:
- 99-54-7
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,2-dichloro-4-nitrobenzene
- Details on test material:
- purity > 99 %
Constituent 1
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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).
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