2,3-epoxypropyl phenyl ether

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientific publications with restrictions compared to Guideline Study (limited documentation)

Data source

Reference

Reference Type:

publication

Title:

The inhalation toxicity of phenylglycidyl ether: Reproduction, mutagenic, teratogenic, and cytogenetic studies

Author:

James B. Terrill1, K.P. Lee, Rudolf Culik, Gerald L. Kennedy Jr.

Year:

1982

Bibliographic source:

Toxicology and Applied Pharmacology, Volume 64, Issue 2, 30 June 1982, Pages 204-212

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

Scientific publications with restrictions compared to Guideline Study (limited documentation)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Name: propane, 1,2-epoxy-3-phenoxy

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

- Source: Charles River Inc.
- Weight at study initiation: Males: ca. 260 g (females not reported)
- Diet (ad libitum): Purina rat chow
- Water (ad libitum)

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

not specified

Vehicle:

not specified

Details on exposure:

Chamber atmospheres were generated by syringe driving the liquid EPP into a heated (310°C) tube. The tube was housed in an oven and constructed in such a way that the nitrogen stream (10 liters/minute) which swept the vapors through the tube was the same temperature as the delivery tube. The exit port of the tube was connected to the top of a 4.5 m3 exposure chamber. Room air at 1,500 liters/minute was also drawn into the chamber at this point.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Atmospheric samples were collected hourly in a midget impinger that contained 15 cc of 0:1 N NaOH in a 50:50 ethanol-water mixture. Analysis was performed by U.V. spectrophotometry at 270 nanometers.

Details on mating procedure:

No data

Duration of treatment / exposure:

- 6 hours/day between 4th and 15th day of gestation
- day that mating was observed is designated day 1.

Frequency of treatment:

daily

Duration of test:

16 days + 4 days observation

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 1, 5, 12 ppm
Basis:
nominal conc.

No. of animals per sex per dose:

25

Control animals:

yes, sham-exposed

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: start and end of the study

POST-MORTEM EXAMINATIONS:
- Sacrifice on gestation day 20
- Organs examined: no data

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes

Fetal examinations:

- External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [1/3 of the litters]
- Skeletal examinations: Yes: [2/3 of the litters]
- Head examinations: No data

Statistics:

- Mann-Whitney U test: number of implantations, live fetuses, and resorptions per litter.
- Fisher’s exact test: Other parameters

Indices:

No data

Historical control data:

No data

Results and discussion

Results (fetuses)

Effect levels (fetuses)

1

Dose descriptor:

NOAEL

Effect level:

12 ppm

Based on:

test mat.

Basis for effect level:

other: teratogenicity

2

Dose descriptor:

NOAEL

Effect level:

12 ppm

Based on:

test mat.

Basis for effect level:

other: fetotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified