Registration Dossier
Registration Dossier
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EC number: 202-764-2 | CAS number: 99-54-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific priciples, only male rats were used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
- Principles of method if other than guideline:
- Single oral application of different doses to male Wistar rats and observation for mortality and signs of toxicity for 14 days.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
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:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 91-121 g (mean: 103 g)
- Fasting period before study: yes, 16 hours
- Diet ad libitum 2 hours post dosing
- Water ad libitum 2 hours post dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4% - Doses:
- 250, 400, 630, 1000 and 1250 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 625 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 526 - <= 744
- Mortality:
- The following deaths occurred within 1-3 days after application:
250 mg: 0/10 rats;
400 mg: 1/10 rats;
630 mg: 5/10 rats;
1000 mg: 9/10 rats;
1250 mg: 10/10 rats - Clinical signs:
- other: moribund animals showed disorders of balance, reduced general condition and died in prone positition.
- Gross pathology:
- section of animals that had died during the study and of animals that survived were without macroscopical findings.
- Other findings:
- no further details
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats and observation of 14 days resulted in LD50 of 625 mg/kg bw.
- Executive summary:
Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats and observation of 14 days resulted in LD50 of 625 mg/kg bw. Signs of intoxication were disorder in balance, reduced general condition and death in prone position (Hoechst AG 1975).
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