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Acute Toxicity: oral

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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:
2001

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

Constituent 1
Chemical structure
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

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:
Clinical signs of decrease in locomotor activity, adoption of an prone position, tremors, irregular respiration and salivation were observed.
Body weight:
Body weights of the treated animals were dose dependently lower than those of the control group.
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 / 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.