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EC number: 248-953-3 | CAS number: 28305-25-1
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD guideline study used for read-across purposes
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)
- Principles of method if other than guideline:
- Method: other
- 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
- IUPAC Name:
- calcium dichloride
- Details on test material:
- Test substance: Fine white granular material marked with FDA 71-87.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 6th to 15th day of pregnancy
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.76, 8.18, 38.0, 176 mg/kg/day
Basis:
- Control animals:
- other: sham-treated
- Details on study design:
- Sex: female
Duration of test: up to the last day of pregnancy
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 176 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 176 mg/kg bw/day
- 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: Fate Summary
-------------------------------------------------------
Group Material Dose*** Total Surviving at
Term
---------------------------
mg/kg Mated Pregnant Total Pregnant*
--------------------------------------------------------
341 Sham 0.0 25 25 25 25
342 Aspirin** 250.0 25 23 25 23
347 CaCl2 1.76 25 22 25 22
348 CaCl2 8.18 25 24 25 24
349 CaCl2 38.0 25 22 25 22
350 CaCl2 176.0 25 24 24 23
--------------------------------------------------------
* Includes all dams examined at term
** Positive Control: 250.0 mg/kg
*** Administered as a water solution
- Table 2: Reproduction Data
--------------------------------------------------------
Group 341 342 347 348 349 350
Dose (mg/kg) sham Aspirin* 1.76 8.18 38.0 176.0
--------------------------------------------------------
-----Pregnancies-----
Total No. 25 23 22 24 22 24
Died or Aborted
(before Day 20) 0 0 0 0 0 1
To term (on Day 20) 25 23 22 24 22 23
-----Live Litters-----
Total No.** 25 18 22 24 22 23
-----Implant Sites-----
Total No. 279 231 234 261 254 246
Average/dam** 11.2 10.0 10.6 10.9 11.6 10.7
-----Resorptions-----
Total No.** 4 62 3 1 1 2
Dams with 1 or more
sites resorbed 3 1 2 1 1 2
Dams with all
sites resorbed - 4 - - - -
% partial resorptions
12.0 47.8 9.09 4.17 4.55 8.70
% complete resorptions
- 17.4 - - - -
-----Live Fetuses-----
Total No. 275 168 231 260 253 244
Average/dam** 11.0 7.30 10.5 10.8 11.5 10.6
Sex ratio (M/F) 1.07 1.06 1.10 0.95 0.90 0.89
-----Dead Fetuses-----
Total** - 1 - - - -
Dams with 1 or
more dead - 1 - - - -
Dams with all dead - 1 - - - -
% partial dead - 4.35 - - - -
% all dead - 4.35 - - - -
-----Average Fetus Weight (g)-----
3.68 2.39 4.13 3.80 3.84 3.72
----------------------------------------------------------
* Positive Control: Aspirin 250.0 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* 1.76 8.18 38.0 176.0
---------------------------------------------------------
Live Fetuses Examined
(at term)
191/25 120/18 161/22 180/2 176/22 173/23
-----Sternebrae-----
Incomplete oss.
86/22 44/15 34/13 53/14 51/16 47/17
Scrambled
Bipartite 1/1 2/2 - 1/1 - 1/1
Fused
Extra
Missing 34/17 103/18 15/9 19/10 18/9 12/7
Other
-----Rids-----
Incomplete oss.
- 15/9 1/1 3/2 - 1/1
Fused/split
Wavy 22/10 41/16 13/9 11/6 34/17 19/10
Less than 12 - 1/1 - 3/1 - -
More than 13 - 95/17 - 4/3 1/1 2/2
Other
-----Vertebrae-----
Incomplete oss.
24/14 76/18 23/10 12/7 34/13 20/9
Scrambled
Fused
Extra ctrs. oss.
Scoliosis - 1/1 - - - -
Tail defects
Other; spina bifida
- 1/1 - - - -
-----Skull-----
Incomplete closure
36/13 54/17 25/11 54/19 40/17 31/13
Missing - 2/2 - - - -
Craniostosis
Other
-----Extremities-----
Incomplete oss. - 3/3 - - - -
Missing
Extra
-----Miscellaneous-----
Hyoid;
missing 26/14 57/17 14/9 9/7 25/9 15/9
Hyoid;
reduced 17/12 8/4 18/7 33/17 23/12 16/10
----------------------------------------------------------
* Positive Control: 250.0 mg/kg
** Numerator = Number of fetuses affected;
Denominator = Numbre of litters affected.
- Table 4: Summary of Soft Tissue Abnormalities
---------------------------------------------------------
Group Material Dose Level Dam Number Description
(mg/kg) of Pups
---------------------------------------------------------
342 Aspirin* 250.0 A7088 1 Meningoencephalocele
A7093 3 Encephalomyelocele;
umbilical hernia
1 Hydrocephalus;
exophthalmos;
gastroschisis
A7107 1 Meningoencephalocele;
umbilical hernia
347 CaCl2 1.76 N6016 1 Gastroschisis
---------------------------------------------------------
* Positive Control: 250.0 mg/kg
- Table 5: Average Body Weights*** (g)
---------------------------------------------------------
Group Material Dose Day0 Day6 Day11 Day15 Day20**
Level
(mg/kg)
---------------------------------------------------------
341 Sham 0.0 232 252 268 295 353
(25)
342 Aspirin* 250.0 226 247 253 268 311
(23)
347 CaCl2 1.76 229 248 265 286 353
(22)
348 CaCl2 8.18 226 246 261 279 345
(24)
349 CaCl2 38.0 226 247 264 285 357
(22)
350 CaCl2 176.0 231 251 262 280 346
(23)
---------------------------------------------------------
* Positive Control: 250.0 mg/kg
** Number of surviving dams in parentheses (c.f. Table 1)
*** Of pregnant dams
Applicant's summary and conclusion
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