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EC number: 200-272-2 | CAS number: 56-40-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- analytical purity of test substance not specified, limited documentation, only organogenesis covered (days 6-15 of gestation)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- (analytical purity of test substance not specified, limited documentation, only organogenesis covered (days 6-15 of gestation))
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycine
- EC Number:
- 200-272-2
- EC Name:
- Glycine
- Cas Number:
- 56-40-6
- Molecular formula:
- C2H5NO2
- IUPAC Name:
- glycine
- Test material form:
- other: fine tan powdered material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 206-215 g
- Housing: individually in mesh bottom cages
- Diet (ad libitum)
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- temperature and humidity-controlled quarters
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1 to 3 mL/kg bw - Details on mating procedure:
- - Impregnation procedure: cohoused
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 6-15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 9 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 185 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 855 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 23 (control group, 185 mg/kg bw/d dose group, 250 mg/kg bw/d Aspirin)
21 (9 mg/kg bw/d)
22 (40, 855 mg/kg bw/day) - Control animals:
- yes, sham-exposed
- other: positive control: 250 mg/kg bw/d Aspirin
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: on days 0, 6, 11, 15, and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- daily observation, but no recording
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20 (caesarean section under surgical anesthesia) - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of implantations: Yes
- Number of resorptions: Yes
- Other: number of live and dead fetuses was recorded and the urigenital tract of each dam was examined in detail for anatomical normality - Fetal examinations:
- Number of live and dead fetuses were recorded and body weights of the live pups were recorded.
- External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [one-third per litter]
- Skeletal examinations: Yes: [two-thirds per litter]
- Head examinations: Yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects. Remark: no treatment-related effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 855 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: no treatment-related effects
Details on embryotoxic / teratogenic effects:
Besides the effects listed in Table 1-3 (see " Any other information on resutls incl. tables"), the following soft tissue abnormalities were found in the positive control group pups delivered by different dams: acrania, craniocele; spina bifida, subcutaneous edema.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 855 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Average maternal body weights (in g)
Day |
|||||
|
0 |
6 |
11 |
15 |
20 |
Dose group |
|
|
|
|
|
Sham |
206 |
236 |
260 |
283 |
352 (23) |
Positive Control |
214 |
236 |
252 |
270 |
309 (23) |
9 mg/kg bw TS |
209 |
230 |
246 |
275 |
344 (21) |
40 mg/kg bw TS |
215 |
240 |
262 |
286 |
351 (22) |
185 mg/kg bw TS |
207 |
227 |
250 |
273 |
243 (23) |
855 mg/kg bw TS |
207 |
229 |
246 |
277 |
343 (22) |
- TS: test substance
- number of surviving dams in parentheses
Table 2: Litter response (caesarean section data)
Dose group |
Sham |
Positive Control |
9 mg/kg bw TS |
40 mg/kg bw TS |
185 mg/kg bw TS |
855 mg/kg bw TS |
Pregnancies |
|
|
|
|
|
|
Total No. |
23 |
23 |
21 |
22 |
23 |
22 |
Died or aborted (before day 20) |
0 |
0 |
0 |
0 |
0 |
1 |
To term (on day 20) |
23 |
23 |
21 |
22 |
23 |
22 |
Corpora lutea |
|
|
|
|
|
|
Total No. |
268 |
270 |
244 |
267 |
265 |
253 |
Average/dam mated |
11.2 |
11.3 |
10.2 |
11.1 |
11.0 |
10.5 |
Live litters |
|
|
|
|
|
|
Total No. |
23 |
15 |
21 |
22 |
23 |
22 |
Implant Sites |
|
|
|
|
|
|
Total No. |
253 |
256 |
233 |
253 |
251 |
252 |
Average/dam |
11.0 |
11.1 |
11.1 |
11.5 |
10.9 |
11 |
Resorptions |
|
|
|
|
|
|
Total No. |
12 |
106 |
8 |
15 |
6 |
4 |
Dams with 1 or more sites resorbed |
6 |
16 |
6 |
11 |
5 |
3 |
Dams with all sites resorbed |
0 |
8 |
0 |
0 |
0 |
0 |
% partial resorptions |
26.1 |
69.6 |
28.6 |
50.0 |
21.7 |
13.6 |
% complete resorptions |
-- |
34.8 |
-- |
-- |
-- |
-- |
Live fetuses |
|
|
|
|
|
|
Total No. |
240 |
150 |
225 |
238 |
245 |
248 |
Average/dam |
10.4 |
6.52 |
10.7 |
10.8 |
10.7 |
10.8 |
Sex ratio (M/F) |
0.81 |
0.95 |
0.67 |
0.68 |
0.55 |
0.76 |
Dead Fetuses |
|
|
|
|
|
|
Total No. |
1 |
0 |
0 |
0 |
0 |
0 |
Dams with 1 or more dead |
1 |
-- |
-- |
-- |
-- |
1 |
Dams with all dead |
0 |
-- |
-- |
-- |
-- |
-- |
% partial dead |
4.35 |
-- |
-- |
-- |
-- |
-- |
% all dead |
-- |
-- |
-- |
-- |
-- |
-- |
Average fetus weight (g) |
3.91 |
2.63 |
3.81 |
3.81 |
3.92 |
3.75 |
Table 3: Summary of skeletal findings
Dose group |
Sham |
Positive Control |
9 mg/kg bw TS |
40 mg/kg bw TS |
185 mg/kg bw TS |
855 mg/kg bw TS |
Live Fetuses (at term) |
161/23 |
99/15 |
148/21 |
159/22 |
164/23 |
167/22 |
Sternebrae |
|
|
|
|
|
|
Incomplete oss. |
15/11 |
94/16 |
10/9 |
8/7 |
11/8 |
13/9 |
Scrambled |
-- |
-- |
-- |
-- |
-- |
-- |
Bipartite |
-- |
1/1 |
-- |
1/1 |
-- |
-- |
Fused |
-- |
-- |
-- |
-- |
-- |
-- |
Extra |
-- |
-- |
-- |
-- |
-- |
-- |
Missing |
2/1 |
64/14 |
-- |
-- |
-- |
-- |
Other |
-- |
-- |
-- |
-- |
-- |
-- |
Ribs |
||||||
Incomplete oss. |
1/1 |
12/6 |
-- |
-- |
-- |
-- |
Fused/Split |
3/2 |
4/3 |
-- |
-- |
-- |
-- |
Wavy |
5/2 |
27/11 |
12/8 |
12/6 |
4/3 |
1/1 |
Less than 12 |
-- |
3/3 |
-- |
1/1 |
-- |
1/1 |
More than13 |
-- |
26/9 |
-- |
-- |
-- |
-- |
Other |
-- |
-- |
-- |
-- |
-- |
-- |
Vertebrae |
||||||
Incomplete oss. |
3/1 |
75/14 |
3/3 |
-- |
2/1 |
4/4 |
Scrambled |
-- |
-- |
-- |
-- |
-- |
-- |
Fused |
-- |
2/2 |
-- |
-- |
-- |
-- |
Extra ctrs. oss. |
-- |
-- |
-- |
-- |
-- |
-- |
Scoliosis |
-- |
7/4 |
-- |
-- |
-- |
-- |
Other |
-- |
-- |
-- |
-- |
-- |
-- |
| Skull | ||||||
| Incomplete closure | 19/11 | 69/13 | 16/10 | 28/10 | 14/8 | 20/10 |
| Craniostosis | -- | 1/1 | -- | -- | -- | -- |
| Miscellaneous | ||||||
| Hyoid; missing | 9/4 | 73/15 | 11/6 | 13/8 | 9/7 | 15/9 |
| Hyoid; reduced | 3/2 | 1/1 | -- | -- | 1/1 | -- |
Applicant's summary and conclusion
- Conclusions:
- The test substance had no effect on intrauterine development.
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