Cumene

Repeated dose toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Cumene

EC Number:

202-704-5

EC Name:

Cumene

Cas Number:

98-82-8

Molecular formula:

C9H12

IUPAC Name:

isopropylbenzene

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

Albino rats, strain not specified

Administration / exposure

Route of administration:

oral: feed

Vehicle:

corn oil

Duration of treatment / exposure:

28d

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
250, 2500, and 6000 ppm.
Basis:
nominal in diet

Doses / concentrations 2

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.