Propionaldehyde

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Teratogenicity and embryolethality of acrolein and structurally related compounds in rats

Author:

Slott VL and Hales BF

Year:

1985

Bibliographic source:

Teratology 32: 65-72

Reference 2

Reference Type:

secondary source

Title:

Propionaldehyde. BUA-Stoffbericht 195

Author:

Beratergremium für umweltrelevante Altstoffe (BUA)

Year:

1996

Bibliographic source:

S. Hirzel Wiss. Verl.-Ges. 1997, Stuttgart

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Intra-amniotic injection on day 13 of gestation. On day 20 of gestation dams were killed and fetuses were removed and analysed.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propionaldehyde

EC Number:

204-623-0

EC Name:

Propionaldehyde

Cas Number:

123-38-6

Molecular formula:

C3H6O

IUPAC Name:

propanal

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Canada, Inc. (St. Constant, Quebec, Canada)
- Age at study initiation: no data
- Weight at study initiation: 225 - 250 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Route of administration:

other: intraamniotic injection

Vehicle:

other: 0.9% NaCl

Details on exposure:

On day 13 of gestation, the pregnant rats were laparotomized under ether anesthesia and the uteri were exposed. Embryos in one uterine horn received a 10 µl intraamniotic infection, using a 30-gauge hydodermic needle. Contralateral embryos were uninjected. Following injections the uterus was repositioned in the abdominal cavity and the laparotomy was closed with two layers of interrupted nylon sutures.

Analytical verification of doses or concentrations:

no

Details on mating procedure:

- Impregnation procedure: purchased timed pregnant
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy

Duration of treatment / exposure:

injection on day 13 of gestation

Frequency of treatment:

single dose

Duration of test:

7 days, rats were killed on day 20 of gestation

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

10 other: µg/fetus (nominal)

Doses / concentrations 2

Dose / conc.:

100 other: µg/fetus (nominal)

Doses / concentrations 3

Dose / conc.:

1 000 other: µg/fetus (nominal)

No. of animals per sex per dose:

6 for 10µg/fetus and 100µg/fetus, respectively
5 for 1000µg/fetus
18 for control group

Control animals:

yes, concurrent no treatment

yes, sham-exposed

Details on study design:

Sex: female
Duration of test: 20 days

Examinations

Maternal examinations:

no data

Ovaries and uterine content:

no data

Fetal examinations:

- External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: all per litter

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:not examined

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:yes

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Propionaldehyde caused a dose-dependent increase of the mortality and absorption rate which amounted to ca. 50 % (p<0.05) at 1000 µg/fetus. A dose-dependent increase of dead or absorbed fetuses (ca. 24 % in the 1000 µg-group) also occurred on the corresponding contralateral uterus side, but the value still lay in the deviation range of the controls. The mortality and absorption rate in the control group was ca. 24 % (injection of physiological saline solution) and amounted to 12 % on the contralateral uterus side. Only one of the fetuses treated with 1000 µg showed a malformation (shortened tail; data unavailable on the number of fetuses examined). In the control group, malformations occurred in 6 % of the fetuses treated with physiological saline solution and in 3 % of the untreated contralateral fetuses (type of malformations unspecified).