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EC number: 204-623-0 | CAS number: 123-38-6
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
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Teratogenicity and embryolethality of acrolein and structurally related compounds in rats
- Author:
- Slott VL and Hales BF
- Year:
- 1 985
- Bibliographic source:
- Teratology 32: 65-72
- Reference Type:
- secondary source
- Title:
- Propionaldehyde. BUA-Stoffbericht 195
- Author:
- Beratergremium für umweltrelevante Altstoffe (BUA)
- Year:
- 1 996
- 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
- Reference substance name:
- Propionaldehyde
- EC Number:
- 204-623-0
- EC Name:
- Propionaldehyde
- Cas Number:
- 123-38-6
- Molecular formula:
- C3H6O
- IUPAC Name:
- propanal
Constituent 1
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 / concentrationsopen allclose all
- Dose / conc.:
- 10 other: µg/fetus (nominal)
- Dose / conc.:
- 100 other: µg/fetus (nominal)
- 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).
Applicant's summary and conclusion
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