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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: Study from the literature, (pre-GLP), in which the test parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data and well documented and scientifically acceptable

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity and limits of solvent residue for sixteen organic solvents
Author:
Kimura ET, Ebert DM and Dodge PW.
Year:
1971
Bibliographic source:
Toxic. Appl. Pharmac. 19, 699-704

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Pre-guideline. Used one sex for some age groups
GLP compliance:
not specified
Test type:
other:
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance:
- Name of test material (as cited in study report): benzene
- Analytical purity: analytical grade, meeting A.C.S. specifications.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight: young adult rats (80-160 g); older adult rats (300-470 g).
- Not fasted prior to dosing
- Dosed by gavage

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
No details of actual doses reported
No. of animals per sex per dose:
Groups of 6 males were used for studies in the young and older adult rats.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: no
- Other examinations performed: none reported
Statistics:
LD50 and associated confidence limits were calculated both by the method of Litchfield and Wilcoxon and by a probit analysis statistical program. Parallel probit analyses were carried out on the LD50 values to compare the potencies within the age groups.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: young and older adults had LD50 of 3.8 (2.9-4.8) and 5.6 (4.0-7.8) mL/kg respectively

Any other information on results incl. tables

Acute oral LD50 in mL/kg (95% CL)

Young adults:  3.8 (2.9 -4.8)

Older adults : 5.6 (4.0 -7.8)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute oral LD50 for adult rats >2000mg/kg
Executive summary:

Acute oral toxicity was determined in groups of at least 6 rats per age and dose level. Benzene was demonstrated to be of low acute oral toxicity (LD50 >2000 mg/kg) and does not warrant classification under Dir 67/548/EEC or GHS