Registration Dossier
Registration Dossier
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EC number: 913-635-1 | CAS number: -
Toxicological information
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data are available on the reaction mass itself neither than on the two components.
However, once the reaction mass of calcium chloride and sodium chloride is taken up by the organism, the effect of the substance on animals and humans should be attributed to calcium ions, chloride ions and sodium ions. Since these three ions are essential constituents of the body, systemic toxicity is considered to be low and no reprotoxic effect is expected.
Furthermore, sodium chloride and calcium chloride are both present in food. Sodium chloride is an essential food additive; daily consumption for adults varies between 2 and 10 g. Calcium chloride was evaluated to be a food substance of very low toxicity and thus the establishment of the acceptable daily intake (ADI) for calcium chloride has not been deemed necessary by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The substance has also been considered as generally recognized as safe (GRAS) substance by the U.S. Food and Drug Administration (USFDA). Systemic toxicity of both components is low and no reprotoxic effect is expected.
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
See attached document in the field 'Attached justification' - Reproductive effects observed:
- not specified
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
See attached document in the field 'attached justification'. - Reproductive effects observed:
- not specified
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
No data are available on the reaction mass itself.
Data are available on calcium chloride, one of the two components of the reaction mass. Three reports are available performed on rats, mice and rabbits by gavage. Based on these Three studies calcium chloride have no impact on the development.
Since the two components have no impact on reproduction, the reaction mass is expected not to induce effect on reproduction.
For the second component, sodium chloride, developmental toxicity studies were not performed on NaCl, as pregnant women typically consume several grams of salt per day (oral exposure) and potentially have dermal exposure to 2-3% NaCl in saltwater when bathing in the ocean. Due to the ubiquitous human exposures to NaCl without causally related developmental effects, animal testing is not necessary. Therefore developmental effect due to sodium chloride is not expected.
Since the two components have no impact on the development, the reaction mass is expected not to induce effect on the development.
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Species:
- mouse
- Strain:
- CD-1
- 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 - 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
- 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
- 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.
- Abnormalities:
- no effects observed
- 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
- 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.
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- 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. - 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- Dutch
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 6th to 18th 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 - 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
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 169 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.
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 169 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- Remarks on result:
- other:
- Remarks:
- No developmental effects related to the substance were seen.
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- The administration of up to 169 mg/kg (body weight) of the
test material to pregnant rats for 13 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. - 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
- 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
- Species:
- rat
- Strain:
- Wistar
- 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 - 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
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- > 176 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 effects related to the substance were observed.
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 176 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- skeletal malformations
- Remarks on result:
- other:
- Remarks:
- No developmental effect related to the substance were observed.
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- No maternal toxicity and no impact on the development related to the substance were observed.
Referenceopen allclose all
- 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
Table 1: Fate Summary
-------------------------------------------------------
Group Material Dose*** Total Surviving at Term
---------------- ---------------
mg/kg Mated Pregnant Total Pregnant*
-------------------------------------------------------
341 Sham 0.0 18 13 18 13
342 6-AN** 2.5 20 10 19 10
347 CaCl2 1.69 22 13 18 12
348 CaCl2 7.85 22 14 16 11
349 CaCl2 35.6 17 14 14 12
350 CaCl2 169.0 16 16 14 14
--------------------------------------------------------
* Includes all dams examined at term
** Positive Control: 2.5 mg/kg of 6-aminonicotinamide
dosed on Day 9
*** Administered as a water solution
- Table 2: Reproduction Data
--------------------------------------------------------
Group 341 342 347 348 349 350
Dose (mg/kg) Sham 6-AN* 1.69 7.85 35.6 169.0
--------------------------------------------------------
-----Pregnancies-----
Total No. 13 10 13 14 14 16
Died or Aborted (before Day 29)
0 1 1 3 2 2
To term (on Day 29)13 10 12 11 12 14
-----Corpora Lutea-----
Total No. 174 122 148 129 138 146
Average/dam mated 9.67 6.42 7.40 7.17 8.63 10.4
-----Live Litters-----
Total No.** 12 10 12 9 11 12
-----Implant Sites-----
Total No. 69 56 86 63 69 72
Average/dam** 5.31 5.60 7.17 7.73 5.75 5.14
-----Resorptions-----
Total No.** 4 2 12 8 8 4
Dams with 1 or more sites resorbed
3 1 4 4 6 3
Dams with all sites resorbed
1 - - 2 1 -
Per cent partial resorptions
23.1 10.0 33.3 36.4 50.0 21.4
Per cent complete resorptions
7.69 - - 18.2 8.33 -
-----Live Fetuses-----
Total No. 65 54 74 55 61 58
Average/dam** 5.00 5.40 6.17 5.00 5.55 4.83
Sex ratio (M/F) 0.86 0.74 1.47 1.04 1.16 1.24
-----Dead Fetuses-----
Total** - - - - - 10
Dams with 1 or more dead
- - - - - 2
Dams with all dead
- - - - - 1
Per cent partial dead
- - - - - 14.3
Per cent all dead - - - - - 7.14
-----Average Fetus Weight (g)-----
38.2 33.8 37.3 38.0 36.8 39.2
---------------------------------------------------------
* Positive Control: 2.5 mg/kg of 6-aminonicotinamide dosed
on Day 9
** 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 6-AN** 1.69 7.85 35.6 169.0
---------------------------------------------------------
Live Fetuses Examined
(at term) 65/12 53/10* 74/12 54/9* 61/11 58/12
-----Sternebrae-----
Incomplete oss. - - 2/1 - 1/1 -
Scrambled
Bipartite - - 1/1 - - -
Fused - 1/1 - - - -
Extra
Missing
Other
-----Rids-----
Incomplete oss.
Fused/split - 2/1 - - - -
Wavy
Less than 12
More than 13
Other
-----Vertebrae-----
Incomplete oss.
Scrambled - 5/1 - - - -
Fused
Extra ctrs. oss.
Scoliosis - 1/1 - - - -
Tail defects - 10/3 - - - -
Other; spina bifida
-----Skull-----
Incomplete closure
1/1 - - - - -
Missing
Craniostosis - - 2/1 - - -
Other
-----Extremities-----
Incomplete oss.
Missing
Extra
-----Miscellaneous-----
---------------------------------------------------------
* One pup lost in processing
** Positive Control: 2.5 mg/kg of 6-aminonicotinamide
dosed on Day 9
*** Numerator = Number of fetuses affected
- Table 4: Summary of Soft Tissue Abnormalities
---------------------------------------------------------
Group Material Dose Level Dam Number Description
(mg/kg) of Pups
---------------------------------------------------------
342 6-AN* 2.5 Z7640 2 Medial rotation
of hind limbs
----------------------------------------------------------
* Positive Control: 2.5 mg/kg of 6-aminonicotinamide dosed
on Day 9
- Table 5: Average body Weights*** (g)
---------------------------------------------------------
Group Material Dose Day0 Day6 Day12 Day18 Day29**
Level
(mg/kg)
---------------------------------------------------------
341 Sham 0.0 2.23 2.32 2.40 2.48 2.59
(13)
342 6-AN* 2.5 1.86 1.94 2.03 2.08 2.18
(10)
347 CaCl2 1.69 2.20 2.31 2.43 2.51 2.64
(12)
348 CaCl2 7.85 2.12 2.16 2.16 2.25 2.33
(11)
349 CaCl2 35.6 2.22 2.31 2.34 2.40 2.50
(12)
350 CaCl2 169.0 2.27 2.39 2.41 2.46 2.50
(14)
---------------------------------------------------------
* Positive Control: 2.5 mg/kg of 6-aninonicotinamide dosed
on Day 9
** Number of surviving dams in parentheses (c.f. Table 1)
*** Of pregnant dams
- 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
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
The two components of the reaction have no impact on reproduction and on development. Therefore, the reaction mass is expected to have no impact on reproduction and on development. No classification is required for these endpoints.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
