2,3-epoxypropyl phenyl ether

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study which meets basic scientific principles.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Reference 2

Reference Type:

publication

Title:

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

Author:

Terrill JB, Lee KP, Culik R, Kennedy GL

Year:

1982

Bibliographic source:

Toxicology and applied pharmacology 64, 204-212

Reference 3

Reference Type:

secondary source

Title:

Phenyl glycidyl ether

Author:

MAK Commission

Year:

1991

Bibliographic source:

MAK List 1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

yes

Remarks:

limited documentation of results

Test material

Test material information

Constituent 1

Reference substance name:

propane, 1,2-epoxy-3-phenoxy

IUPAC Name:

propane, 1,2-epoxy-3-phenoxy

Details on test material:

- Name of test material (as cited in study report): propane, 1,2-epoxy-3-phenoxy
No further information.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Weight at study initiation: ca. 200 g
No further information.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

not specified

Vehicle:

not specified

Details on exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
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.

TEST ATMOSPHERE
- Brief description of analytical method used: 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 by U.V. spectrophotometry at 270 nanometers.
- Samples taken from breathing zone: no data

Details on mating procedure:

No further information.

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 (animals were sacrificed on day 20)

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0, 1, 5, 12 ppm
Basis:
nominal conc.
corresponding to ca. 0, 0.006, 0.03, 0.07 mg/l (calculated by Derelanko M, 2008)

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0, 1.75, 5.84, 11.2 ppm
Basis:
analytical 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: at 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:

The number of implantations, live fetuses, and resorptions per litter were analyzed by the Mann-Whitney U test. Other parameters, such as partial resorptions, were analyzed by Fisher’s exact test.

Indices:

No data.

Historical control data:

No data.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no data

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

1

Dose descriptor:

NOAEL

Effect level:

ca. 0.07 mg/L air (nominal)

Based on:

test mat.

Remarks:

corresponding to 12 ppm

Basis for effect level:

other: teratogenicity

2

Dose descriptor:

NOAEL

Effect level:

ca. 0.07 mg/L air (nominal)

Based on:

test mat.

Remarks:

corresponding to 12 ppm

Basis for effect level:

other: fetotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Table 1: Effect of inhalation exposure to phenylglycidyl ether on the outcome of pregnancy and fetal development of the rat

	Exposure levels (ppm)
	0 (control)		2		5		12
Parameter	Mean	S.D.	Mean	S.D.	Mean	S.D.	Mean	S.D.
Females bred	25		25		25		25
Females pregnant (%)	24 (96)		24 (96)		23 (92)		21 (84)
Corpora Lutea/pregnant female	11.1	2.1	10.7	1.8	11.2	1.9	10.7	2.7
Implantations/litter	9.5	1.7	9.3	2.2	9.8	1.0	9.2	1.9
Live fetuses/litter	9.0	2.1	8.9	2.3	9.5	1.0	8.0	1.9
Litters with early resorptions (%)	8 (33.3)		7 (29.2)		6 (26.1)		6 (28.6)
Litters with late resorptions (%)	1 (4.2)		0		0		0
Litters with partial resorptions (%)	9 (37.5)		7 (29.2)		6 (26.1)		6 (28.6)
Resorptions/ litters with resorptions	1.3	0.6	1.3	0.5	1.0	0.0	1.3	0.5
Initial body weight of pregnant female	168.3	8.5	171.2	11.6	172.5	7.9	107.2	10.3
Final body weight of pregnant female	289	17.9	283.8	22	290.7	21.4	279.4	20.7
Fetal crown-rump length (cm)	3.8	0.2	3.7	0.1	3.7	0.2	3.7	0.2
Fetal weight (g)	4.1	0.5	4.1	0.5	4.1	0.4	4.2	0.3