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EC number: 202-425-9 | CAS number: 95-50-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study; no deviations mentioned
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- deviations mentioned
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-dichlorobenzene
- EC Number:
- 202-425-9
- EC Name:
- 1,2-dichlorobenzene
- Cas Number:
- 95-50-1
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,2-dichlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): o-dichlorobenzene
- Analytical purity: 99.7%
- Lot/batch No.: 8803302
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 25
- Humidity (%): 50 - 65
- Photoperiod (hrs dark / hrs light): 12 / 12 (light from 7 - 19 o'clock)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- Males: 0 (vehicle only), 500, 1000, 2000 mg/kg bw
Females: 2000 mg/kg bw - No. of animals per sex per dose:
- 5 animals per sex and dose group
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 3 deaths occured of male rats given 2000 mg/kg bw.
- Clinical signs:
- other: Clinical signs of decrease in locomotor activity, adoption of an prone position, tremors, irregular respiration and salivation were observed.
- Gross pathology:
- At autopsy, pale discoloration of the liver and accumulation of dark colored fluid in th urinary bladder were observed in dead animals.
- Other findings:
- - Histopathology: The liver showed degeneration and/or necrosis of hepatocytes accentuated in the centrilobular area in dead animals and centrilobular hypertrophy of hepatocytes in a surviors.
Any other information on results incl. tables
Table 1: Mortality of rats treated with o-dichlorobenzene in the single dose oral toxicity study
| Sex | Dose | No. of | Number of animals died in corresponding time period after administration |
Mortality (a) | |||||||||
| mg/kg bw | animals | 0 -1 h | 1 -2h | 2 -3 h | 3 -4 h | 4 -5 h | 5 -6 h | 2 days | 3 days | 4 days | 5 -15 days | ||
| Male | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 / 5 |
| 500 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 / 5 | |
| 1000 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 / 5 | |
| 2000 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 3 / 5 | |
| female | 2000 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 / 5 |
(a) : Number of animals died / Number of animals examined
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dose oral toxicity study of 1,2-dichlorobenzene was conducted according to OECD guideline 401. The LD50 values were estimated to be greater than 2000 mg/kg for males and females.
- Executive summary:
Nagata et al., 2001
A single dose oral toxicity study of 1,2-dichlorobenzene was conducted according to OECD guideline 401. The GLP study was considered to be reliable because no deviations were mentioned.
Male Crj: CD(SD) rats were dosed with 0 (vehicle only), 500, 1000, or 2000 mg/kg bw of 1,2-dichlorobenzene. In addition, female Crj: CD(SD) rats were administered 2000 mg/kg bw in order to show that there were no gender-specific differences. According to guideline, 5 animals per dose group and sex were used.
Deaths occured of male rats given 2000 mg/kg bw. Clinical signs of decrease in locomotor activity, adoption of a prone position, tremors, irregular respiration and salivation were observed. Body weights of the treated animals were dose dependently lower than those of the control group. At autopsy, pale discolorationof the liver and accumulation of dark colored fluid in the urinary bladder were observed in dead animals. histopathologically, the liver showed dageneration and /or necrosis of hepatocytes accentuated in the centrilobular area in dead animals and cnetrilobular hypertrophy of hepatocytes in a survivors.
The LD50 values were estimated to be greater than 2000 mg/kg for males and females.
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