[(o-methoxyphenoxy)methyl]oxirane

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Study duration:

subacute

Species:

rat

Quality of whole database:

The studies were performed in compliance with the principles of the Good Laboratory Practice (GLP).

Additional information

Methods: Administration by gavage to 3 groups, each of 10 male and 10 female Wistar rats, for up to 8 weeks (including a two weeks maturation phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 500 mg/kg bw/day.

A Control group (10 males and 10 females) was dosed with vehicle alone.

Results:

There were no deaths attributable to test item toxicity. No treatment-related effects were detected in behavioural, funcional performance, sensory reactivity, body weight change, food and water consumption.

No treatment-related effects were detected in mating performance and in the lenght of gestation.

No treatment-related effects on fertility were detected.

Blood chemistry: Animal of either sex treated with 500 mg/kg bw/day showed increases in bile acid values when compared to controls. Females treated with 500 and 100 mg/kg bw/day also showed increases in bilirubin levels. Organ weights: an increase in absolute and body weight-relative kidney weights were detected for females treated with 500 and 100 mg/kg bw/day. At necropsy, no treatment-related macroscopic abnormalities were detected. Microscopic examination revealed in liver minimal to slight centrilobular hepatocyte hypertrophy for males at 500 mg/kg bw/day. Females were not affected.

Short description of key information:
The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and is compatible with the requirements of the OECD Guidelines no. 422 "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test" (adopted 22 March 1996).

Effects on developmental toxicity

Description of key information

The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and is compatible with the requirements of the OECD Guidelines no. 422 "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test" (adopted 22 March 1996).

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Study duration:

subacute

Species:

rat

Quality of whole database:

The studies were performed in compliance with the principles of the Good Laboratory Practice (GLP).

Additional information

Methods: Administration by gavage to 3 groups, each of 10 male and 10 female Wistar rats, for up to 8 weeks (including a two weeks maturation phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 500 mg/kg bw/day.

A Control group (10 males and 10 females) was dosed with vehicle alone.

Results:

No differences were detected in offspring litter size and viability, offspring growth and development.

Justification for classification or non-classification

The oral administration of the test item to rats by gavage, at dose levels of 500, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at 500 and 100 mg/kg bw/day. The changes detected were considered not to be adverse in nature; the NOAEL for systemic toxicity was considered to be 500 mg/kg bw/day.

30 mg/kg bw/day was established to be the NOEL.

No treatment-relataed effects were detected for reproductive performance or subsequent offspring development. The NOEL for reproductive toxicity was considered to be 500 mg/kg bw/day.