Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 244-499-5 | CAS number: 21651-19-4
- 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:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Significant methodological deficiencies - purity of the test substances were not stated Deficiencies: - number of pregnant females was too low - information on gravid uterus weight (including cervix), number of corpora lutea, number of dead foetuses, foetal sex as well as on external, skeletal and soft alterations of foetuses were missing - clinical observation and macroscopic examination of dams were missing - intervals of recording body weight and food consumption were not stated - individual animal data was not given
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- publication
- Title:
- Placental transfer of fluoride and tin in rats given various fluoride and tin salts
- Author:
- Theuer, R.C. et al.
- Year:
- 1 971
- Bibliographic source:
- J. Nutr., 101: 525-532.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Pregnant Sprague-Dawley rats were fed a diet containing tin fluoride from day 0 of pregnancy until gestation day 20. Body weight of dams, food/water intake, number of implantation sites, number of resorption, number of live foetuses, number of litters, placental weight, foetal weight as well as tin levels in foetuses and placentas were recorded.
- GLP compliance:
- not specified
- Remarks:
- GLP was not compulsory at time of study conduct
- Limit test:
- no
Test material
- Reference substance name:
- Tin difluoride
- EC Number:
- 231-999-3
- EC Name:
- Tin difluoride
- Cas Number:
- 7783-47-3
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): stannous fluoride (obtained from Ozark-Mahoning, Tulsa, Okla.)
- Molecular formula: SnF2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Sprague-Dawley derived rats
- Source: Laboratory Supply Co., Indianapolis, Ind.
- Age at the start of gestation: 15 to 19 weeks
- Weight at the start of gestation: 252 to 285 g
- Housing: housed individually in screened-bottom galvanized cages
- Diet (ad libitum): low fluoride basal diet (≤2 ppm fluoride; tin was not detectable (i.e., <0.5 ppm))
- Water (ad libitum)
- Acclimation period: 12 weeks before mating weanlings were acclimatised
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: hydrolysed corn starch
- Details on exposure:
- DIET PREPARATION
The tin-containing salt was ground in a mortar and pestle and triturated in partially hydrolysed corn starch to insure adequate distribution in the diets. The salt was blended with about 50 times its weight of this starch, and micropulverised. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- After formulation, the diet was analysed for tin. Tin levels in diet were determined by emission spectroscopy (Gibb, 1942)*. The lower limit of detection of the method was 0.5 ppm tin in the diet.
*Reference:
- Gibb, T. R. P. 1942 Optical methods of chemical analysis. McGraw-Hill Book Co., New York, pp. 49 - 52. - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: female rats in groups were caged with proven breeder males from the same supplier. The impregnated females were returned to individual cages.
- M/F ratio per cage: 2 males / 12 females
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- ad libitum
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
158, 310, and 625 ppm tin
Basis:
analytical conc.
- No. of animals per sex per dose:
- not clearly stated, but at least 9 to 10 females with live foetuses
- Control animals:
- yes, plain diet
- Details on study design:
- no data
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes, weight gain was obtained
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food intake: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: twice weekly; water bottles were changed and intake calculated from the difference between initial and final weight of each bottle.
POST-MORTEM EXAMINATIONS: No data
Females were sacrificed on gestation day 20. - Ovaries and uterine content:
- Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantation sites: Yes
- Number of resorptions: Yes
- Number of live foetuses
- Number of litters
- Placentas were removed, weighed and frozen individually on dry ice. They were stored prior to analysis for tin.
Tin levels in placentas were determined by emission spectroscopy (Gibb, 1942)*. The lower limit of detection of the method was 0.05 ppm tin in the placentas.
*Reference:
- Gibb, T. R. P. 1942 Optical methods of chemical analysis. McGraw-Hill Book Co., New York, pp. 49 - 52. - Fetal examinations:
- The foetuses were removed, weighed and frozen individually on dry ice. They were stored prior to analysis for tin.
Tin levels in foetuses were determined by emission spectroscopy (Gibb, 1942)*. The lower limit of detection of the method was 0.05 ppm tin in the foetuses.
- External examinations: Yes, foetal weight
- Soft tissue examinations: No data
- Skeletal examinations: No data
- Head examinations: No data
*Reference:
- Gibb, T. R. P. 1942 Optical methods of chemical analysis. McGraw-Hill Book Co., New York, pp. 49 - 52. - Statistics:
- Statistically significant effects of test salts and test salt level were determined by two-way analysis of variance of the values for the animals in relevant groups. Duncan's multiple range test was used to determine statistically significant differences between individual means at the 95% confidence level (Steel and Torrie, 1960)*.
*Reference:
- Steel, R. G. D., and J. H. Torrie 1960 Principles and Procedures of Statistics. McGraw-Hill Book Co., New York. - Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
REPRODUCTIVE PERFORMANCE
- reproductive performance of the animals fed the diet was excellent.
- average number of viable foetuses per litter (ranges): SnF2: 11 to 12; control (plain diet): 12
- average placental weight showed little variation (ranges): SnF2: 0.47 to 0.52 g); control (plain diet): 0.48 g
- a few other pregnant female rats were allowed to give birth to young; parturition occurred most frequently 23 days after detection of sperm in the vagina.
- foetal resorptions: SnFl2: 0 of 30 litters; control (plain diet): 0 of 9).
WATER INTAKE, FOOD INTAKE, AND WEIGHT GAIN DURING GESTATION
- analysis of 7-day food intake showed that the level of test salt had a significant effect (P<0.05).
- weight gain during the first week of pregnancy was significantly affected by test salt level (P<<0.01).
- rats fed the highest levels of stannous fluoride gained significantly (P<0.05) less weight than rats fed the lowest level of this salt.
- total net weight gain was highly significantly related both to salt level (p<<0.01).
- rats fed the highest level of the test salt containing fluoride had a significantly (p<0.05) reduced net weight gain during pregnancy compared to the lowest level of the test salt.
- net weight gain of the rats fed the highest level of stannous fluoride was significantly (p<0.05) lower than that of the rats in other group.
- placental level of tin bore little relationship to the tin level in the diet.
- placenta contained relatively little tin whether the diet contained detectable tin or not.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
FOETAL TIN LEVELS
- foetal tin values were higher when the females were fed test salts containing tin.
- no consistent stepwise increase in foetal tin as dietary tin increased.
- statistical analysis of the foetal tin levels of groups fed 125, 250, or 500 ppm tin, indicated a significant (p<0.05) effect of dietary tin level on foetal tin level.
- average foetal weight for each group (ranges): SnF2: 3.4 to 3.9 g/pup; control (plain diet): 3.7
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 625 ppm (analytical)
- Based on:
- element
- Remarks:
- tin (test salt: SnF2)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to the authors, there was no effect on the numbers of litters, resorptions, live foetuses per litter, mean placental and foetal weights if tin fluoride was administered.
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.