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EC number: 200-831-0 | CAS number: 75-01-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline study, published in peer-reviewed literature, minor restrictions in design and reporting, but otherwise adequate for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The effects of maternally inhaled vinyl chloride on embryonal and fetal development in mice, rats, and rabbits
- Author:
- John JA, Smith FA, Leong BKJ, Schwetz BA.
- Year:
- 1 977
- Bibliographic source:
- Toxicol Appl Pharmacol 39:497-513
- Reference Type:
- publication
- Title:
- Vinyl chloride: Inhalation teratology study in mice, rats, and rabbits.
- Author:
- John JA, Smith FA, Schwetz BA.
- Year:
- 1 981
- Bibliographic source:
- Environ Health Perspect 41:171-177
Materials and methods
- Principles of method if other than guideline:
- Exposure of pregnant rats during the period of major organogenesis.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Chloroethylene
- EC Number:
- 200-831-0
- EC Name:
- Chloroethylene
- Cas Number:
- 75-01-4
- Molecular formula:
- C2H3Cl
- IUPAC Name:
- chloroethene
- Details on test material:
- Inhibited vinyl chloride monomer from Matheson Gas Products, Joliet, IL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Exposure was conducted in 3.7 cubic meter chambers. The atmosphere was generated by diluting gaseous vinyl chloride with filtered room air.
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- The day on which a vaginal plug or sperm was seen in a vaginal smear was considered to be Day 0 of pregnancy.
- Duration of treatment / exposure:
- The animals were exposed during days 6-19 (7 h/day) of gestation
- Frequency of treatment:
- 7 h/day
- Duration of test:
- Animals were sacrificed on day 21 of gestation.
- No. of animals per sex per dose:
- Twenty eight animals (controls) were exposed to air and 31 animals were exposed to 500 ppm vinyl chloride by inhalation in the first experiment.
Nineteen animals (controls) were exposed to air, 16 animals were exposed to 2500 ppm VC by inhalation, and 16 animals were exposed to 2500 ppm by inhalation plus 15% ethanol in drinking water in the second experiment. - Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- BODY WEIGHT:
Days 6, 10, 16 and 21
FOOD CONSUMPTION AND COMPOUND INTAKE
Food consumption was examined every 3 days - Fetal examinations:
- Number and position of live, dead and resorbed fetuses, sex, weight and length (crown-rump) and external and skeletal condition of fetuses were measured. Soft tissues of one-third of each litter were examined microscopically.
- Statistics:
- The Fishers exact probability test was used to evaluate the incidence of resorption among litters. Body weights, body measurements and maternal liver weights were analyzed using ANOVA and a Dunnett's test. The incidence of fetal anomalies was analyzed using a Wilcoxon test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Decreased weight gain was found in rats exposed to 500 ppm Vinyl chloride (VCM) (Table 1). Decreased feed consumption and increased absolute and relative liver weight were found in animals exposed to 2500 ppm VCM. There was no significant effect of exposure on maternal death.
Reproductive Indices:
There was no significant effect of exposure on the number of litters, number of implantation sites/dam, number of implanations or litters resorbed, or percent pregnant. The number of corpora lutea/dam and pregnancy wastage (the number of corpora lutea minus the number of implants) decreased in rats exposed to 500 ppm VCM, but not 2500 ppm VCM (Table 2).
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 500 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 2 500 ppm
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
No significant effect of exposure on number of live fetuses/litter, sex ratio, or overall incidence of gross, soft tissue or skeletal anomalies was noted. A significant decrease in fetal body weight and an increase in crown-rump length were observed in animals exposed to 500 ppm VCM but not 2500 ppm VCM (Table 2). The incidence of unilateral or bilateral dilated ureters increased in animals exposed to 2500 ppm VCM but not 2500 ppm VCM + ethanol (Table 3). An increased incidence of rib spurs was noted in animals exposed to 500 VCM but not 2500 ppm VCM. In general, effects were augmented in animals exposed to VCM and ethanol.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table
1. Maternal weight gain, liver weights and feed consumption in rats
exposed to VCM
ppm
VCM
Parameters 0
500
Number
of dams 28
31
Weight
gain days 6-21 148+11
125+19*
Relative
liver weight, mg/g 36.5+4.1
37.1+2.6
Feed consumption days 6-15 21+2
22+2
ppm
VCM
Parameters 0
2500
2500^
Number of dams 19
16
16
Weight gain 127+15
138+23
120+15**
days
6-21
Relative liver 34.4+3.3
37.8+2.6*
42.1+2.4**
weight,
mg/g
Feed consumption 22+2
21+2*
13+2**
days
6-15
^
also treated with 15% ethanol in drinking water
* p0.05 from control; ** p0.05 from VCM alone
Table
2. Observations
made during C-section of rats exposed to VCM
ppm
VCM
Parameters 0
500
Number
of dams 28
31
Corpora
lutea/dam 15+3
13+2*
Fetal body weight, g 5.67+0.29
5.44+0.38*
Fetal crown-rump length, mm 42.6+1.2 43.6+0.8*
ppm
VCM
Parameters 0
2500
2500^
Number of dams 19
16
16
Corpora lutea/dam 14+2
15+2*
14+2**
Fetal body weight, g 5.59+0.27
5.62+0.29
5.34+0.32**
Fetal crown-rump 43.6+1.5
43.3+1.1
42.4+0.9**
length,
mm
^ also treated with 15% ethanol in drinking water
* p0.05 from control; ** p0.05 from VCM alone
Table
3. Incidence
of skeletal malformations of rats exposed to VCM
ppm
VCM
Parameters 0
500
Number
examined, fetuses (litters)
gross
339
(28) 387
(31)
soft
tissue 113
(28) 129
(31)
skeletals
337
(28) 387
(31)
fetuses
affected (%) (litters affected, %)
gross anomalies
omphalocele
0
1 (3)
soft tissue
micropthalmia
0
0
dilated
ureter (uni or bilateral) 2
(7) 2
(6)
small
kidney 0
0
skeletal tissue
sternebrae
unfused
0
1 (6)
ribs
spurs
1
(4) 9
(52)*
vertebrae
missing
cervical centra 0.3
(4) 2
(16)
skull
delayed
ossification 16
(61) 12
(61)
unfused
0
0
ppm
VCM
Parameters 0
2500
2500^
Number examined, fetuses (litters)
gross
229
(19) 214
(16) 188
(16)
soft
tissue 76
(19) 73
(16) 63
(16)
skeletals
229
(19) 214
(16) 188
(16)
fetuses
affected (%) (litters affected, %)
gross anomalies
omphalocele
0.4
(5) 0
0.5
(6)
soft tissue
micropthalmia
0
0
2 (6)
dilated
ureter 5
(10) 27
(50)* 5
(19)**
(uni
or bilateral)
small
kidney 0
0
2
(6)
skeletal tissue
sternebrae
unfused
3 (32)
0.5
(6) 1
(12)
ribs
spurs
0.4
(5) 0
0.5
(6)
vertebrae
missing
cervical 14
(68) 12
(69) 35
(69)
centra
skull
delayed
ossification 18
(58) 6
(31) 3
(25)
unfused
53
(90) 3
(12) 2
(12)
^ also treated with 15% ethanol in drinking water
* p0.05 from control; ** p0.05 from VCM alone
Applicant's summary and conclusion
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