Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: other route
Adequacy of study:
other information

Data source

Reference
Title:
No information
Author:
Irons R.D. & Moore B.J. Res. Commun. Chem. Path. Pharmac.|27, 147 155, 1980.

Materials and methods

Principles of method if other than guideline:
Method: other
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS

Laboratory reagent grade benzene tested.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female

Administration / exposure

Route of administration:
subcutaneous
Duration of treatment / exposure:
10 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.25, 0.5 ml/kg bw/day (converts to 219.5, 439 mg/kg bw/day); 8 or 9 rabbits/dose
Control animals:
yes, concurrent vehicle
Details on study design:
Post-exposure period: 30 days

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
< 219.5 mg/kg bw/day
Sex:
female
Dose descriptor:
LOAEL
Effect level:
219.5 mg/kg bw/day
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

A dose- and time-dependent decrease in circulating lymphocytes which partially recovered 30 days after treatment, was noted.  Circulating monocytes were significantly decreased in the top-dosed animals.

Applicant's summary and conclusion