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Toxicological information

Toxicity to reproduction

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.