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Diss Factsheets
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EC number: 914-103-1 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Validation of an in Vivo Developmental Toxicity Screen in the Mouse.
- Author:
- Seidenberg JM et al.
- Year:
- 1 986
- Bibliographic source:
- Teratogenesis, Carcinogenesis, and Mutagenesis 6: 361-374.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Screening test with 55 chemicals, in which mice were dosed by oral intubation on days 8 through 12 of gestation (day 1 = day plug found). Mice were allowed to deliver, and neonates were examined, counted, and weighed on the day of birth (day 1) and day 3. Dead neonates were recovered from the nest and externally examined for abnormalities.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 7727-73-3
- EC Number:
- 616-445-4
- Cas Number:
- 7727-73-3
- IUPAC Name:
- 7727-73-3
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- O4S.2Na
- IUPAC Name:
- sodium sulfate
- Reference substance name:
- disodium sulfate decahydrate
- IUPAC Name:
- disodium sulfate decahydrate
- Details on test material:
- Sodium sulfate; no further data
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
adult barrier-reared ICR/SIM mice
- Source: Simonsen Laboratories (Gilroy, CA)
- Weight at study initiation: 32 - 36 g
- Housing: individually in 32 X 23 X 15 cm suspended polycarbonate shoebox cages
- Diet (ad libitum): Simonsen Custom Lab Diet 7
- Water (ad libitum): UV purified drinking water
Mice were either received from the supplier timed-pregnant or were bred in-house.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Proof of pregnancy: vaginal plug referred to as day 1 of pregnancy
- Duration of treatment / exposure:
- days 8 through 12 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 3 post partum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2800 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 28 females per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: days 7 and 13 of gestation, day 1 post partum
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
POST-MORTEM EXAMINATIONS: Yes - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes, for dams not given birth by gestation day 21 or 22
- Fetal examinations:
- Neonates were examined, counted, and weighed on the day of birth (day 1) and day 3. Dead neonates were recovered from the nest and externally examined for abnormalities
- Statistics:
- All analyses compared individual treatment groups and their concurrent controls. Maternal body weight gain during treatment (day 13 minus day 7 weight) was assessed by a two-tailed analysis of variance. A one-tailed analysis of variance was used to assess live and dead litter size data. The calculation of the average live litter size on days 1 and 3 and the average number of neonates found dead per litter on day 1 included only those litters that were born. Litters that were alive in utero at necropsy and those that were completely resorbed will be discussed as appropriate, but were not included in this average. A one-tailed Fisher's exact probability test was used to assess neonatal survival ratios. Neonatal body weight was assessed by a two-tailed analysis of variance. To correct for differences in litter size, the number of live neonates born was used as a covariant in the body weight analyses.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 800 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2 800 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 800 mg/kg bw/day (actual dose received)
- 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
No evidence of maternal toxicity (mortality, body weight gain), or increased resorption rates was found. The test substance had no effects on pup survival, and no adverse developmental effects were observed. When compared to vehicle controls, birth weight was significantly increased. All of the confirmed teratogens tested in this study resulted in decreased live-born litter size.
Table: Maternal and perinatal effects of sodium sulphate
Treatment |
Maternal response |
Perinatal response |
Average neonatal weight (g +/- SD) |
|||||||||
Compound |
Dose (mg/kg/d) |
No. dead/ No. treated |
Average weight gain (g+/-SD) |
No. of litters |
Average no. of neonated/litter (+/- SD) |
% survival days 1-3 |
day 1 |
day 3 |
2-day gain |
|||
born |
resorbed |
live day 1 |
dead day 1 |
live day 3 |
||||||||
Vehicle |
--- |
0/28 |
8.5 +/- 1.7 |
25 |
0 |
13.3 +/- 3.8 |
0.16 +/- 0.5 |
13.2 +/- 3.8 |
99 |
1.72 +/- 0.13 |
2.42 +/- 0.25 |
0.70 +/- 0.15 |
Test substance |
2800 |
0/28 |
8.6 +/- 1.7 |
24 |
0 |
12.9 +/- 2.5 |
0.04 +/- 0.2 |
12.8 +/- 2.4 |
100 |
1.80 +/- 0.14 * |
2.58 +/- 0.29 |
0.78 +/- 0.18 |
* p<0.05
Applicant's summary and conclusion
- Executive summary:
Oral administration of sodium sulphate, 2800 mg/kg bw/d to pregnant ICR mice on gd 8 - 12 did not produce maternally toxic or embryo-/fetotoxic effects nor teratogenic effects when compared with concurrent vehicle controls. Confirmed teratogens which were also tested in this study resulted in decreased live-born litter size.
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