3-phenoxybenzylic alcohol

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

two-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from peer reviewed journal

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Details of guidelines not mentioned in publication. Estrogenic activity was estimated in Sprague–Dawley rats

GLP compliance:

not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Texas A&M University
Department of Comparative Medicine
- Age at study initiation: Adult female rats
Fasting period before study: No data available
- Housing: in controlled conditions
Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):23°C
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): lights on, 06:00 h, lights off, 18:00 h

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on mating procedure:

No data

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

10 Days i.e. on PND 22 and continuing until vaginal opening (VO) occurred

Frequency of treatment:

Daily

Details on study schedule:

No data available

Remarks:

Doses / Concentrations:
1.0, 5.0, or 10.0 mg/kg/day
Basis:
nominal in diet

No. of animals per sex per dose:

Animals were randomly assigned to treatment groups

Parental animals: Observations and examinations:

Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
Time schedule for examinations: daily

Oestrous cyclicity (parental animals):

No Data

Sperm parameters (parental animals):

No Data

Litter observations:

No Data

Postmortem examinations (parental animals):

No Data

Postmortem examinations (offspring):

No Data

Statistics:

No Data

Reproductive indices:

No Data

Offspring viability indices:

No Data

Clinical signs:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Other effects:

not specified

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

not specified

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

No effect on body weight gain

Sexual maturation:

effects observed, treatment-related

Description (incidence and severity):

No differences was observed from control, as all animals the smear on the day of VO was either proestrus or estrus.

On pups animals, vaginal lavage was performed daily and cytology was observed until first diestrus (D1) indicating sexual maturity

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

10 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

other: Estrous cycle

Reproductive effects observed:

not specified

Reproductive function: estrous cycle: No differences was observed from control, as all animals the smear on the day of VO was either proestrus or estrus.

Conclusions:

In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.

Executive summary:

In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

10 mg/kg bw/day

Study duration:

subacute

Quality of whole database:

The data is K2 level as the data has been obtained from the experimental study published in peer reviewed journal.

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.

Justification for selection of Effect on fertility via oral route:
In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.