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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data sheet with overview of serveral studies, no full test report available. However, all relevant information is given. Therefore, the study can be regarded as valid for assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male albino rats were exposed for 28 d to 3 concentrations of cumene (10 animals per group) and one control. Substance was given as 2% corn oil solution and blended with the basal laboratory ration. Survival, food consumption, organ weights and terminal body weights were evaluated.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Albino rats, strain not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
corn oil
Duration of treatment / exposure:
28d
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
250, 2500, and 6000 ppm.
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
22.8, 224.8, and 535.8 mg/kg/d
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOEL
Effect level:
> 535.8 mg/kg bw/day (actual dose received)
Sex:
male
Basis for effect level:
other: No effects were observed in study. Only significant finding was increased testis at 224.8 mg/kg/d, however, there was no dose-response relationship.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Mortality

Organweights ratio (%)

Terminal body weights (g)

Dose (ppm)

Liver

Kidney

Adrenals (mg%)

Testes

Control

0

4.92

0.88

19

0.97

284 ± 16

250

0

4.26

0.91

18

1.09

276 ± 34

2500

0

4.27

0.89

17

1.12*

283 ± 18

6000

0

4.19

0.91

18

1.04

267 ± 25

* Statistically significant difference (p>0.05) compared to control

No deaths ocured during the study and no untoward behavioral reactions were noted.

Body weight gain and food consumption over the course of the study is listed in figure in the report and showed no dose-response relationship.

At autopsy, no significant gross lesions were noted among rats when compared to control rats.

Applicant's summary and conclusion

Conclusions:
No NOEL could be established in this study, as no effects occured during the exposure period of 28d. The only significant finding was increased testis at medium dose, however this effects showed no dose response relationship.
Executive summary:

Male albino rats were exposed for 28 d to 3 concentrations of cumene (10 per group) and one control. Substance was given as 2% corn oil solution and blended with the basal laboratory ration. Based on food consumption the daily intake was 22.8, 224.8, and 535.8 mg/kg/d. Survival, food consumption, organ weights and terminal body weights was not affected.