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EC number: 225-403-0 | CAS number: 4826-71-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973-1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- only one-third of each litter were examined
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 002
- EC Number:
- 600-059-8
- Cas Number:
- 10031-30-8
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Fine white crystalline material.
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 30 ± 1 g
- Fasting period before study: no data
- Housing: in disposable plastic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Virgin adult female albino outbred mice were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- 10 days (from day 6 to day 15 of gestation)
- Frequency of treatment:
- Daily
- Duration of test:
- 17 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.65 mg/kg bw/day
- Dose / conc.:
- 21.6 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 465 mg/kg bw/day
- No. of animals per sex per dose:
- Sham: 22 animals
Positive control: 20 animals
4.65 mg/kg: 24 animals
21.6 mg/kg: 19 animals
100 mg/kg: 22 animals
465 mg/kg: 23 animals - Control animals:
- yes, concurrent vehicle
- other: Aspirin 150 mg/kg (positive control)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations: appearance and behaviour.
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 11, 15, and 17 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17
- Organs examined: sternebrae, ribs, vertebrae, skull, extremities - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Number of dead fetuses: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: one-third per litter
- Skeletal examinations: Yes: two-thirds per litter
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, non-treatment-related
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, non-treatment-related
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 465 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- dead fetuses
- early or late resorptions
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Visceral malformations:
- effects observed, non-treatment-related
- Other effects:
- not specified
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 465 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1. Fate summary
Material |
Dose** mg/kg |
Total |
Surviving at Term |
||
Mated |
Pregnant |
Total |
Pregnant1 |
||
Sham |
0 |
25 |
22 |
25 |
22 |
Aspirin* |
150 |
25 |
20 |
24 |
19 |
Monocalcium phosphate |
4.65 |
25 |
24 |
25 |
24 |
Monocalcium phosphate |
21.6 |
26 |
19 |
26 |
19 |
Monocalcium phosphate |
100 |
23 |
22 |
23 |
22 |
Monocalcium phosphate |
465 |
25 |
23 |
25 |
23 |
* Positive Control: 150 mg/kg
** Administered as a water solution (10 ml per kg of body weight)
1includes all dams examined at term
Table 2. Reproduction data.
|
Sham |
Aspirin** |
Monocalcium phosphate 4.65 mg/kg |
Monocalcium phosphate 21.6 mg/kg |
Monocalcium phosphate 100 mg/kg |
Monocalcium phosphate 465 mg/kg |
Pregnancies |
|
|
|
|
|
|
Total No. |
22 |
20 |
24 |
19 |
22 |
23 |
Died or aborted (before Day 17) |
0 |
1 |
0 |
0 |
0 |
0 |
To term (on Day 17) |
22 |
19 |
24 |
19 |
22 |
23 |
Live Litters |
|
|
|
|
|
|
Total No.* |
22 |
19 |
24 |
19 |
22 |
22 |
Implant sites |
|
|
|
|
|
|
Total No. |
261 |
224 |
283 |
225 |
244 |
265 |
Average/dam* |
11.9 |
11.8 |
11.8 |
11.8 |
11.1 |
11.5 |
Resorptions |
|
|
|
|
|
|
Total No.* |
8 |
20 |
19 |
4 |
12 |
28 |
Dams with 1 or more sites resorbed |
7 |
9 |
13 |
3 |
10 |
12 |
Dams with all sites resorbed |
-- |
-- |
-- |
-- |
-- |
1 |
Per cent partial resorptions |
31.8 |
47.4 |
54.2 |
15.8 |
45.5 |
52.2 |
Per cent complete resorptions |
-- |
-- |
-- |
-- |
-- |
4.35 |
Live Fetuses |
|
|
|
|
|
|
Total No. |
252 |
201 |
261 |
221 |
230 |
233 |
Average/dam* |
11.5 |
10.6 |
10.9 |
11.6 |
10.5 |
10.1 |
Sex ratio (M/F) |
1.02 |
0.88 |
0.78 |
0.92 |
1.13 |
0.93 |
Dead Fetuses |
|
|
|
|
|
|
Total* |
1 |
3 |
-- |
-- |
2 |
4 |
Dams with 1 or more dead |
1 |
3 |
-- |
-- |
2 |
3 |
Dams with all dead |
-- |
-- |
-- |
-- |
-- |
-- |
Per cent partial dead |
4.55 |
15.8 |
-- |
-- |
9.09 |
13.0 |
Per cent all dead |
-- |
-- |
-- |
-- |
-- |
-- |
Average Fetus Weight, g |
0.84 |
0.81 |
0.88 |
0.87 |
0.82 |
0.85 |
* Includes only those dams examined at term
** Positive control: 150 mg/kg
Table 3. Summary of skeletal findings.
|
Sham |
Aspirin** |
Monocalcium phosphate 4.65 mg/kg |
Monocalcium phosphate 21.6 mg/kg |
Monocalcium phosphate 100 mg/kg |
Monocalcium phosphate 465 mg/kg |
Live Fetuses Examined (at term) |
179/22 |
141/19 |
186/24 |
155/19 |
162/22 |
164/22 |
Sternebrae |
|
|
|
|
|
|
Incomplete oss. |
10/8 |
31/10 |
18/9 |
27/15 |
22/10 |
28/15 |
Scrambled |
|
|
|
|
|
|
Bipartite |
8/7 |
3/3 |
11/8 |
9/7 |
10/8 |
9/6 |
Fused |
|
|
|
|
|
|
Extra |
|
6/3 |
|
|
|
|
Missing |
23/10 |
28/11 |
13/9 |
13/6 |
32/14 |
23/7 |
Other |
|
|
|
|
|
|
Ribs |
|
|
|
|
|
|
Incomplete oss. |
|
|
|
|
|
9/4 |
Fused/split |
|
2/2 |
|
|
|
|
Wavy |
|
1/1 |
2/2 |
|
|
|
Less than 12 |
1/1 |
|
1/1 |
|
|
1/1 |
Less than 13 |
48/18 |
30/12 |
42/18 |
18/11 |
32/15 |
34/17 |
Other |
|
|
|
|
|
|
Vertebrae |
|
|
|
|
|
|
Incomplete oss. |
9/6 |
9/3 |
2/2 |
1/1 |
11/4 |
13/4 |
Scrambled |
|
|
|
|
|
|
Fused |
|
|
|
|
|
|
Extra ctrs. Oss. |
|
|
|
|
|
|
Scoliosis |
|
|
|
|
|
|
Tail defects |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Skull |
|
|
|
|
|
|
Incomplete closure |
|
2/2 |
|
|
|
|
Missing |
|
|
1/1 |
|
|
|
Craniostosis |
|
|
|
|
|
|
Other, facial bones, inc. |
|
|
|
|
|
2/1 |
Extremities |
|
|
|
|
|
|
Incomplete oss. |
7/5 |
5/3 |
2/2 |
|
10/5 |
14/4 |
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
Miscellaneous |
|
|
|
|
|
|
Hyoid; missing |
37/16 |
33/11 |
13/15 |
22/12 |
52/15 |
33/13 |
Hyoid; reduced |
17/11 |
25/12 |
17/11 |
21/14 |
15/11 |
27/14 |
* Number of fetuses affected/number of litters
** Positive control: 150 mg/kg
Table 3-a. Summary of soft tissue abnormalities.
Material |
Dose level (mg/kg) |
Dam |
Number of pups |
Description |
Aspirin* |
150 |
A 6068 |
1 |
Cleft palate; gastroschisis |
*Positive control: 150 mg/kg
Table 4. Average body weights of pregnant dams.
Material |
Dose level (mg/kg) |
Day 0 |
Day 6 |
Day 11 |
Day 15 |
Day 17* |
Sham |
0 |
30.5 |
32.7 |
37.1 |
44.1 |
51.3 (22) |
Aspirin** |
150 |
30.0 |
32.2 |
33.7 |
40.6 |
47.0 (19) |
Monocalcium phosphate |
4.65 |
29.3 |
32.3 |
36.5 |
43.7 |
50.2 (24) |
Monocalcium phosphate |
21.6 |
29.8 |
32.2 |
36.4 |
44.3 |
50.8 (19) |
Monocalcium phosphate |
100 |
30.6 |
33.5 |
36.7 |
44.0 |
48.1 (22) |
Monocalcium phosphate |
465 |
29.2 |
32.3 |
35.1 |
42.8 |
47.8 (23) |
* Number of surviving dams in parenthesis (c.f. Table 1)
** Positive control: 150 mg/kg
Applicant's summary and conclusion
- Conclusions:
- The test item up to 465 mg/kg bw/day did not exhibit any maternal toxicity, fetal survival, teratogenicity in female mice CD-1. Therefore, the NOAEL in mice was higher than 465 mg/kg bw/d.
- Executive summary:
A study was conducted to assess the teratogenic potential of the oral administration of monocalcium phosphate in mice by a method similar to OECD 414. Starting from day 0 of gestation, female mated CD-1 mice were orally administered 0 (sham), 4.65, 21.6, 100 or 465 mg/kg bw for 10 consecutive days. A positive control group was administered in parallel with 150 mg/kg of aspirin. Maternal examinations had no clearly discernible effect on nidation or on maternal or fetal survival. Resorptions and dead fetuses were counted. One-third of the fetuses from each litter underwent detailed visceral examinations. The remaining two-thirds were examined for skeletal defects. Based on the test results, the test item up to 465 mg/kg bw/day did not exhibit any maternal toxicity, fetal survival, teratogenicity in female mice CD-1. Therefore, the NOAEL for both maternal and developmental toxicity in mice was higher than 465 mg/kg bw/d.
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