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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, documentation restricted and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
10 male Wistar rats/group; 0.3, 0.4, 0.5, 0.6 and 0.7 ml/kg; p.a. observation period 14 days
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): nitrobenzene
- Analytical purity: 99.9%
- Impurities (identity and concentrations): dinitrobenzene (< 0.07%), benzen (< 0.01%), water (< 0.01%), nitrophenole (< 3ppm), sulfur (> 1 ppm), hydrocarbons (> 10 ppm), nitrotoluene ( > 20 ppm)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0.3, 0.4, 0.5, 0.6 and 0.7 mL/kg (equivalent to 360, 480, 600, 720 and 840 mg/kg bw)
No. of animals per sex per dose:
10
Control animals:
no
Statistics:
Chi-square test with 95% confidence limits.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
588 mg/kg bw
95% CL:
480 - 648

Any other information on results incl. tables

A dose of 360 mg/kg did not cause mortalities, but all of the animals demonstrated clinical signs. These clinical signs included cyanosis (all dose groups), perturbance of equilibrium, piloerection, sedation 600 – 840 mg/kg bw), bloody eyes and poor reflexes. In animals receiving up to 480 mg/kg bw, clinical signs occurred 1 h after administration whereas in all other dose groups they occurred alreade after 15 min. 2/10 rats died after administration of 480 mg/kg, 5/10 rats after 600 mg/kg, 8/10 rats after 720 mg/kg and all 10 rats after 840 mg/kg. Mortalities occurred on days 2 to 4. Information on necropsy is not given.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU