3-phenoxybenzylic alcohol

Toxicity to reproduction

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

The pyrethroid metabolites 3-phenoxybenzoic acid and 3-phenoxybenzyl alcohol do not exhibit estrogenic activity in the MCF-7 human breast carcinoma cell line or Sprague–Dawley rats

Author:

Brian Laffin, Marco Chavez, Michelle Pine

Year:

2010

Bibliographic source:

Toxicology 267 (2010) 39–44

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

3-phenoxybenzylic alcohol

EC Number:

237-525-1

EC Name:

3-phenoxybenzylic alcohol

Cas Number:

13826-35-2

Molecular formula:

C13H12O2

IUPAC Name:

(3-phenoxyphenyl)methanol

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

CAS No: 13826-35-2
Chemical Name: 3-phenoxybenzylic alcohol
Nature of chemical: Organic

Test animals

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

Administration / exposure

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

Doses / concentrations

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

Examinations

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

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

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 / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

not specified

Results: F1 generation

General toxicity (F1)

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.

Details on results (F1)

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

Effect levels (F1)

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

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.