Registration Dossier
Registration Dossier
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EC number: 202-764-2 | CAS number: 99-54-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific priciples, only female rats were used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- TS (40 % solution) was applied on the clipped skin of the back under occlusive conditions over 24 hrs, then the skin was washed,
post application observation period: 14 d
feed and water ad libitum
observation for signs of intoxication
rats were weighed daily (excluding weekend)
after termination of the observation time: rats were necropsied and gross pathologically examined - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- 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:
- no data on purity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
- Weight at study initiation: 167-193 g
- Housing: individually
- Diet . ad libitum
- Water: ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: sesame oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm²
- Type of wrap if used: alu foil
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed: 0/6
- Clinical signs:
- other:
- Gross pathology:
- The macroscopic examination after 14 d showed no adverse effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An LD50 > 2000 mg/kg bw is determined.
- Executive summary:
Single dermal application of 1,2 -Dichloro-4-nitrobenzene at a dose of 2000 mg/kg bw/d to the shaved, intact back of 6 female rats caused no mortality and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975).
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