Registration Dossier
Registration Dossier
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EC number: 913-635-1 | CAS number: -
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Calcium chloride
- EC Number:
- 233-140-8
- EC Name:
- Calcium chloride
- Cas Number:
- 10043-52-4
- Molecular formula:
- CaCl2
- IUPAC Name:
- calcium dichloride
- Details on test material:
- Test substance: Tine white granular material marked with FDA 71-87.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 6th to 15th day of pregnancy
- Frequency of treatment:
- daily
- Control animals:
- yes, sham-exposed
- Details on study design:
- Sex: female
Duration of test: up to the last day of pregnancy
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 189 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- mortality
- Remarks on result:
- other: see remarks
- Remarks:
- No maternal effects related to the substance were observed.
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 189 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- No substances related effects were seen on development.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- external malformations
- skeletal malformations
- Remarks on result:
- other:
- Remarks:
- No developmental effects related to the substance were observed.
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
- Table 1: Fate Summary
---------------------------------------------------------
Group Material Dose*** Total Surviving
mg/kg at Term
-------------- --------------
Mated Pregnant Total Pregnant*
---------------------------------------------------------
341 Sham 0.0 25 22 25 22
342 Aspirin** 150 25 19 25 19
347 CaCl2 1.89 25 22 25 22
348 CaCl2 8.78 25 21 24 20
349 CaCl2 40.8 25 21 25 21
350 CaCl2 189.0 25 23 25 23
---------------------------------------------------------
* Includes all dams examined at term
** Positive Control: 150.0 mg/kg
*** Administered as a water solution (10 ml/kg-bw) - Table 2 : Reproduction Data
--------------------------------------------------------
Group 341 342 347 348 349 350
Dose (mg/kg) Sham Aspirin* 1.89 8.78 40.8 189.0
--------------------------------------------------------
-----Pregnancies-----
Total No. 22 19 22 21 21 23
Died or Aborted (before Day 17)
0 0 0 1 0 0
To term (on Day 17)
22 19 22 20 21 23
-----Live Litters-----
Total No.** 21 29 21 20 21 21
-----Implant Sites-----
Total No. 251 240 244 248 235 272
Average/dam** 11.4 12.6 11.6 12.4 11.2 11.8
-----Resorptions-----
Total No.** 19 8 12 7 5 35
Dams with 1 or more sites resorbed
6 5 8 6 4 13
Dams with all sites resorbed
1 - 1 - - 2
% partial resorptions
27.3 26.3 36.4 30.0 19.1 56.5
% complete resorptions
4.55 - 4.55 - - 8.70
-----Live Fetuses-----
Total No. 229 224 229 238 227 234
Average/dam** 10.4 11.8 10.4 11.9 10.8 10.2
Sex ratio (M/F) 1.16 1.07 0.80 0.84 0.89 0.93
-----Dead Fetuses-----
Total** 3 8 3 3 3 3
Dams with 1 or more dead
2 6 3 3 3 3
Dams with all dead
- - - - - -
Per cent partial dead
9.09 31.6 13.6 15.0 14.3 13.0
Per cent all dead - - - - - -
-----Average Fetus Weight (g)-----
0.89 0.87 0.90 0.93 0.91 0.90
---------------------------------------------------------
* Positive Control: 150.0 mg/kg
** Includes only those dams examined at term.
- Table 3: Summary of Skeletal Findings**
---------------------------------------------------------
Group No. 341 342 347 348 349 350
Dose (mg/kg) Sham Aspirin* 1.89 8.78 40.8 189.0
---------------------------------------------------------
Live Fetuses Examined
(at term) 158/21 160/19 160/21 162/20 159/21 161/21
-----Sternebrae-----
Incomplete oss.
25/10 28/10 21/11 15/6 24/10 12/5
Scrambled
Bipartite 11/9 9/7 3/3 12/8 13/10 7/6
Fused
Extra
Missing 9/7 11/5 16/10 12/5 10/6 12/5
Other
-----Rids-----
Incomplete oss.
Fused/split
Wavy - - - - 1/1 -
Less than 12
More than 13 41/14 30/12 28/12 42/14 35/14 20/12
Other
-----Vertebrae-----
Incomplete oss.
3/3 1/1 2/2 - - 2/2
Scrambled
Fused
Extra ctrs. oss.
Scoliosis
Tail defects
Other
-----Skull-----
Incomplete closure
Missing
Craniostosis
Other;facial bones,inc
1/1 - - - - -
-----Extremities-----
Incomplete oss. 1/1 1/1 1/1 - - 2/2
Missing
Extra
-----Miscellaneous-----
Hyoid; missing 23/14 23/11 33/14 26/11 20/10 30/13
Hyoid; reduced 23/13 4/4 22/14 12/9 23/12 12/9
---------------------------------------------------------
* Positive Control: 150.0 mg/kg
** Numerator = Number of fetuses affected
Denominator = Number of litters affected
- Table 4: Summary of Soft Tissue Abnormalities
---------------------------------------------------------
Group Material Dose Level Dam Number Description
(mg/kg) of Pups
---------------------------------------------------------
342 Aspirin* 150.0 A6102 1 Gastroschisis
349 CaCl2 40.8 N5070 1 Umbilical hernia
350 CaCl2 189.0 N5112 1 Cleft palate
---------------------------------------------------------
* Positive Control: 150.0 mg/kg
- Table 5: Average body Weights*** (g)
--------------------------------------------------------
Group Material Dose Day0 Day6 Day11 Day15 Day17**
Level
(mg/kg)
---------------------------------------------------------
341 Sham 0.0 27.7 30.6 34.5 41.1 46.8
(22)
342 Aspirin* 150.0 28.7 31.9 35.0 43.4 50.2
(19)
347 CaCl2 1.89 29.3 31.3 35.4 43.6 49.2
(22)
348 CaCl2 8.78 28.7 30.7 35.2 45.2 51.5
(20)
349 CaCl2 40.8 29.0 30.9 35.8 44.1 50.2
(21)
350 CaCl2 189.0 30.9 33.6 37.4 45.4 50.4
(23)
---------------------------------------------------------
* Positive Control: 150.0 mg/kg
** Number of surviving dams in parentheses (c.f. Table 1)
*** Of pregnant dams
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 189 mg/kg (body weight) of the
test material to pregnant mice for 10 consecutive days had
no clearly discernible effect on nidation or on maternal or
fetal survival. The number of abnormalities seen in either
soft or skeletal tissues of the test groups did not differ
from the number occurring spontaneously in the sham-treated
controls.
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