Cyclohexene

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Remarks:

combined repeated dose and reproduction / developmental screening

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexene

EC Number:

203-807-8

EC Name:

Cyclohexene

Cas Number:

110-83-8

Molecular formula:

C6H10

IUPAC Name:

cyclohexene

Details on test material:

- Analytical purity:98.6wt%
- Impurities (identity and concentrations):0.01wt% BHT(2,6-Di-tert-butyl-4-methylphenol) is included as antioxidant

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

EST ANIMALS
- Source:Charles River Japan
- Age at study initiation:8 weeks
- Weight at study initiation:male 341-406g, female 207-252g
- Fasting period before study:
- Housing:1/cage
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:7days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21.8-25.4
- Humidity (%):39-73
- Air changes (per hr):15/hr
- Photoperiod (hrs dark / hrs light): 12hr/12hr

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

50 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

- Mortality: There was no mortality related to the test substance treatment. Clinical signs: Salivation was apparent in three animals of 150 mg/kg b.w. group and in twelve animals of 500 mg/kg b.w. group for males and in two animals of 150 mg/kg b.w. group and twelve animals of 500 mg/kg b.w. group for females. Although the grades of salivation were not reported, the sign was observed for about 5 minutes after dosing at 150 mg/kg b.w. , and for 30 minutes to 5 hours after dosing at 500 mg/kg b.w. during treatment period. In addition, lacrimation was observed in two animals of 500 mg/kg b.w. group for males and in one animal each of 150 and 500 mg/kg b.w. groups for females. The onsets and grades of lacrimation were not reported.

- Body weight: No statistically significant changes for males and females. Food consumption: No effects for males and females.

- Urinalysis: No statistically significant changes.

- Hematology: No effects for males and females

- Blood biochemistry: Males: Decreases in triglyceride in 150 and 500 mg/kg b.w. groups, increases in total bilirubin in 500 mg/kg b.w. group, and total bile acid in 150 and 500 mg/kg b.w..

- Necropsy and histopathology: No adverse effects for males and females Organ weights: Males: Increase in a relative kidney weight in 500 mg/kg b.w. group. Females: No statistically significant changes.

- Histopathology: No changes related to test substance.

Applicant's summary and conclusion

Conclusions:

In oral repeated dose studies in rats, salivation is observed in both sexes at 150mg/kg b.w. and above. The NOAEL is considered to be 50mg/kg b.w./day.

Executive summary:

In oral repeated dose studies in rats, salivation is observed in both sexes at 150mg/kg b.w. and above. The NOAEL is considered to be 50mg/kg b.w./day.