Cyclohexene

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

500 mg/kg bw/day

Sex:

male/female

Results: F1 generation

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

500 mg/kg bw/day

Sex:

male/female

Overall reproductive toxicity

Reproductive 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..

Females: Increase in total bile acid in 50, 150, and 500mg/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 changes. Histopathology: No changes related to test substance.

- Reproductive and developmental parameters: No effects observed on reproductive performance in males and females given each dose, and developmental performance of the newborns.

Applicant's summary and conclusion

Conclusions:

In an OECD combined study, there are no effects of cyclohexene on reproduction/developmental parameters. The NOAEL for reproduction/developmental toxcity is considered to be 500mg/kg b.w./day.

Executive summary:

In an OECD combined study, there are no effects of cyclohexene on reproduction/developmental parameters. The NOAEL for reproduction/developmental toxcity is considered to be 500mg/kg b.w./day.