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Toxicological information

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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with accepatable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Toxic responses to acute, subchronic, and chronic oral administrations of monochlorobenzene to rodents.
Author:
Kluwe, W.M. et al.
Year:
1985
Bibliographic source:
Journal of toxicology and environmental health, 15: 745-767

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Animals were not fasted prior treatment. LC50 was not statistically calculated. Individual body weight was not determined at any time of the experiment. Necropsy was not carried out.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monochlorobenzene
- Physical state: liquid
- Analytical purity: > 99.9%

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Indianapolis, US
- Age at study initiation: 6-8 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: Polycarbonate boxes covered with polyester filter sheets
- Diet (e.g. ad libitum): free access to Purina Lab Chow pellets, Ralston Purina, St. Louis, MO, US
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Maximum dose volume applied: 5 mL/kg bw
Doses:
250, 500, 1000, 2000, 4000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: observations were performed 2 times per day

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Single oral administration produced deaths at doses of 4000 mg/kg in male and female rats.
Clinical signs:
Transient ataxia, labored breathing, and prostration were observed in a dose-related manner in rats at the two higher doses.
Hyperpnea was frequently observed in all monochlorobenzene exposed rats shortly after chemical administration
Body weight:
not determined
Gross pathology:
no data

Any other information on results incl. tables

Dose (mg/kg)             Male                                   Female
                         Mortality (day of death)        Mortality (day of death) a


 250 mg/kg:               0/5                                          0/5
 500 mg/kg:               1/5 (2)                                    0/5
1000 mg/kg:              0/5                                          2/5 (3,3)
2000 mg/kg:              1/5 (2)                                   0/5
4000 mg/kg:              3/5 (2,2,2)                              4/5 (2,2,2,2)

a: Day of study on which death occurred

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Executive summary:
In an acute oral toxicology study, F344/N rats have been administered with 250, 500, 1000, 2000 or 4000 mg/kg corn oil of chlorobenzene. The LD50 was greater than 2000 mg/kg body weight. The following intoxication symptoms have been observed: transient ataxia, laboured breathing and prostration in a dose-related manner at the two higher doses. Hyperpnea was as well frequently observed in all exposed rats shorrtly after administration. On the basis of this study chlorobenzene is not classified. The study was performed according to OECD guideline 401 with acceptable restrictions.