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EC number: 231-835-0 | CAS number: 7758-16-9
- 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Meets generally accepted scientific standards with acceptable restrictions. Deficiencies: Food consumption not reported Uterine weights or copora lutea not determined One third used for visceral examination; should be 50% Test substance identification (Batch etc) missing No details on housing conditions/source of animals Administration only during periods of organogenesis, not until day before pregnancy
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not specified
- Principles of method if other than guideline:
- Adult female golden hamsters were mated with mature males (1:1). Observation of motile sperm in the vaginal smear was considered as Day 0 of gestation. Dosing by oral intubation with a control (Vehicle at level equivalent to group receiving the highest dose or aspirin at 250 mg/kg) or test article in a water suspension at 1.66, 7.71, 35.8 and 166.0 mg/kg was carried out daily on Days 6 to 10 of gestation. Observations of body weight, appearence, behaviour, and food consumption were performed. On Day 14 of gestation all dams underwent Caesarean section. Implantation sites, resorption sites and live/dead foetuses recorded. Body weights of live pups recorded. Genital tract of each dam examined for anatomical normality. All foetuses examined grossly for presence of external congenital abnormalities. One third foetuses of each litter underwent detailed visceral examination and the remaining two thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Disodium dihydrogenpyrophosphate
- EC Number:
- 231-835-0
- EC Name:
- Disodium dihydrogenpyrophosphate
- Cas Number:
- 7758-16-9
- Molecular formula:
- H4O7P2.2Na
- IUPAC Name:
- Sodium acid pyrophosphate
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-61 (sodium acid pyrophosphate)
- Physical state: Fine white powdered material
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- other: Golden
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Outbred
- Age at study initiation: No data
- Weight at study initiation: 122.2 - 133.4 g
- Fasting period before study: No data
- Housing: Individually housed in mesh-bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
IN-LIFE DATES: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE: Water
- Amount of vehicle (if gavage): 1 mL/kg bw at doses equal to or below 250 mg/kg bw and 2 mL/kg at doses up to 500 mg/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: 1:1 mating
- Proof of pregnancy: appearence of motile sperm in vaginal smear - Duration of treatment / exposure:
- 5 days (Day 6 to Day 10 of gestation)
- Frequency of treatment:
- Daily
- Duration of test:
- 14 days
- No. of animals per sex per dose:
- Table 1 Number of animals dosed
Material Dose (mg/kg) Total
Mated Pregnant
Sham 0.0 22 20
Aspirin 250 22 21
FDA 71-81 1.66 22 20
7.71 24 20
35.8 22 21
166.0 22 22 - Control animals:
- yes, sham-exposed
- other: positive control: 250 mg/kg aspirin
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Appearence, behaviour, food consumption and weight observed daily.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights recorded on days 0, 6, 8, 10 and 14.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- Organs examined: uterus and genital tract - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: Yes - Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 166 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 166 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects noted
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Dose (mg/kg) |
Sham |
Aspirin |
1.66 |
7.71 |
35.8 |
166.0 |
Pregnancies |
|
|
|
|
|
|
Total No. |
20 |
21 |
20 |
20 |
21 |
22 |
Died or aborted (before Day 14) |
0 |
0 |
0 |
0 |
1 |
1 |
To term (on Day 14) |
20 |
21 |
20 |
20 |
20 |
21 |
Live litters |
|
|
|
|
|
|
Total No.* |
20 |
21 |
20 |
20 |
20 |
21 |
Implant Sites |
|
|
|
|
|
|
Total No. |
298 |
311 |
292 |
289 |
290 |
300 |
Average/dam* |
14.9 |
14.8 |
14.6 |
14.5 |
14.5 |
14.3 |
Resorptions |
|
|
|
|
|
|
Total No* |
1 |
8 |
1 |
1 |
1 |
8 |
Dams with 1 or more sites resorbed |
1 |
6 |
1 |
1 |
1 |
5 |
Dams with all sites resorbed |
-- |
-- |
-- |
-- |
-- |
-- |
Per cent partial resorptions |
5.00 |
28.6 |
5.00 |
5.00 |
5.00 |
23.8 |
Per cent complete resorptions |
-- |
-- |
-- |
-- |
-- |
-- |
Live foetuses |
|
|
|
|
|
|
Total No |
295 |
303 |
291 |
288 |
289 |
292 |
Average/dam* |
14.8 |
14.4 |
14.6 |
14.4 |
14.5 |
13.9 |
Sex ratio (M/F) |
0.89 |
0.94 |
0.81 |
0.78 |
0.75 |
0.75 |
Dead Foetuses |
|
|
|
|
|
|
Total No.* |
2 |
-- |
-- |
-- |
-- |
-- |
Dams with 1 or more dead |
2 |
-- |
-- |
-- |
-- |
-- |
Dams with all dead |
-- |
-- |
-- |
-- |
-- |
-- |
Per cent partial dead |
10.0 |
-- |
-- |
-- |
-- |
-- |
Per cent all dead |
-- |
-- |
-- |
-- |
-- |
-- |
Average foetus weight (g) |
1.70 |
1.72 |
1.72 |
1.82 |
1.82 |
1.75 |
* Includes only those dams examined at term
** Positive control: 250 mg/kg
Table 3 Summary of skeletal findings
Findings |
Dose (mg/kg) |
|||||
Sham |
Aspirin |
1.66 |
7.71 |
35.8 |
166.0 |
|
Live foetuses examined (at term) |
204/20 |
209/21 |
200/20 |
199/20 |
202/20 |
202/21 |
Sternebrae |
|
|
|
|
|
|
Incomplete oss. |
131/20 |
85/20 |
124/20 |
69/17 |
88/18 |
80/20 |
Scrambled |
|
|
|
|
|
|
Bipartite |
18/9 |
16/11 |
22/14 |
20/11 |
15/9 |
25/13 |
Fused |
|
|
|
|
|
|
Extra |
8/2 |
|
1/1 |
6/3 |
5/3 |
|
Missing |
53/14 |
48/13 |
49/12 |
39/10 |
33/10 |
51/14 |
Other |
|
|
|
|
|
|
Ribs |
|
|
|
|
|
|
Incomplete oss. |
|
|
|
|
|
|
Fused/split |
|
|
|
|
|
2/1 |
Wavy |
|
|
|
|
|
|
Less than 12 |
|
|
|
|
|
|
More than 13 |
62/17 |
56/13 |
46/16 |
69/17 |
38/13 |
60/16 |
Other |
|
|
|
|
|
|
Vertebrae |
|
|
|
|
|
|
Incomplete oss. |
2/2 |
15/5 |
|
1/1 |
|
8/2 |
Scrambled |
|
|
|
|
|
|
Fused |
|
|
|
|
|
|
Extra ctrs. oss. |
|
|
|
|
|
|
Scoliosis |
|
|
|
|
|
|
Tail defects |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Skull |
|
|
|
|
|
|
Incomplete closure |
|
|
|
|
|
|
Missing |
|
|
|
|
|
|
Craniostosis |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Extremities |
|
|
|
|
|
|
Incomplete oss. |
4/4 |
17/6 |
|
6/4 |
|
13/3 |
Missing |
|
|
|
|
|
|
Extra |
|
|
|
|
|
|
Miscellaneous |
|
|
|
|
|
|
Hyoid; missing |
6/6 |
14/6 |
5/4 |
4/2 |
2/1 |
13/3 |
Hyoid; reduced |
7/7 |
6/5 |
9/7 |
7/3 |
6/5 |
8/6 |
* Numerator = Number of foetuses affected; Denominator = Number of litters affected
** Positive control: 250 mg/kg
Table 4 Summary of soft tissue abnormalities
Material |
Dose level (mg/kg) |
Dam |
Number of pups |
Description |
Sham |
0.0 |
S 5908 |
1 |
Meningoencephalocele |
|
|
S 5914 |
1 |
Hydrocephalus |
Aspirin |
250.0 |
A 5912 |
1 |
Hepatomegaly |
FDA 71-61 |
1.66 |
M 5013 |
1 |
Hydrocephalus |
FDA 71-61 |
166.0 |
M 5092 |
4 |
Hydrocephalus |
|
|
|
2 |
Hydromyelia |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test material administered to pregnant hamsters for 5 days up to a dose level of 166 mg/kg bw showed no maternal or developmental toxicity. The NOAEL for both maternal and fetotoxicity is > 166 mg/kg bw.
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