Registration Dossier
Registration Dossier
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EC number: 231-302-2 | CAS number: 7488-55-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reference is considered reliable with restrictions (conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001)) Restrictions/deviation/deficiencies in comparison to OECD TG 414: - purity of the test substance was not stated - each group should preferably contain approx. 20 female animals with implantation sites at necropsy, whereas in this study only 10 - 12 pregnant females were present in the groups. - test substance should be administered until the day prior to scheduled caesarean section. In this study the dosing was stopped eleven days before caesarean section. - body weight was neither recorded on the first day of dosing nor at least every 3 days during the dosing period. - food consumption was not recorded at three-day intervals and did not coincide with days of body weight determination. Food consumption appeared to be part of the clinical observations which were conducted daily. - gross pathological examination of the females consisted only of the examination of the urogenital tract. - uteri of non-pregnant females were not further examined (e.g. Salewski staining) to confirm the non-pregnant status - gravid uteri including the cervix were not weighed. - head examinations were not carried out - no data on clinical signs were provided. - age and individual weight of the animals were not given - no analysis of dose administered - data on number and percent of pre- and post-implantation losses were not given
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reference is considered reliable with restrictions (conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001)) Restrictions/deviation/deficiencies in comparison to OECD TG 414: - purity of the test substance was not stated - body weight was neither recorded on the first day of dosing nor at least every 3 days during the dosing period. - food consumption was not recorded at three-day intervals and did not coincide with days of body weight determination. Food consumption appeared to be part of the clinical observations conducted daily. - gross pathological examination of the females consisted only of the examination of the urogenital tract. - uteri of non-pregnant females were not further examined (e.g. by ammonium sulfide staining) to confirm the non-pregnant status - gravid uteri including the cervix were not weighed. - whereas commonly approximately one-half of each litter is prepared and examined for skeletal alterations and the remainder for soft tissue alterations, in this study instead one-third of each litter was prepared for soft tissue alterations and two-thirds for skeletal tissue alterations. - data on clinical signs were not provided. - age and individual weight of the animals were not given - no analysis of dose administered - data on number and percent of pre- and post-implantation losses were not given
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001). For details on deviations/deficiencies see technical dossier.
- GLP compliance:
- not specified
- Remarks:
- GLP was not compulsory at time of study conduct
- Limit test:
- no
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age: adult
- Weight (average per dose level; day 0 of gestation; pregnant dams): control group: 31.1 g; 0.5 mg/kg: 30.5 g; 2.3 mg/kg: 32.3 g; 11.0 mg/kg: 33.1 g; 50.0 mg/kg: 30.7 g: positive control: 33.1 g
- Housing: individually housed in disposable plastic cages in temperature and humidity-controlled quarters
- Diet (ad libitum)
- Water (ad libitum): fresh tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was administered as a water solution; 1.0 mL/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: females were mated with young adult males
- Proof of pregnancy: vaginal sperm plug referred to as day 0 of gestation - Duration of treatment / exposure:
- Day 6 through Day 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 17 days
- Dose / conc.:
- 0 other: mg Sn / kg diet
- Dose / conc.:
- 0.5 other: mg Sn / kg diet
- Dose / conc.:
- 2.3 other: mg Sn / kg diet
- Dose / conc.:
- 11 other: mg Sn / kg diet
- Dose / conc.:
- 50 other: mg Sn / kg diet
- No. of animals per sex per dose:
- Treatment groups: 22 - 26 mated females (20 - 23 pregnant females)
Control group: 29 mated females (21 pregnant females) - Control animals:
- yes, sham-exposed
- Details on study design:
- - Positive control: 150 mg/kg aspirin (24 mated females received the positive control; 20 females were pregnant)
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: appearance and behaviour with particular attention to food consumption and weight
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 11, 15, and 17 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17
- Organs examined: urogenital tract - 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: Yes
- Number of implantation sites: Yes
- Number of resorption sites: Yes
- Numbers of live and dead foetuses were recorded - Fetal examinations:
- - External examinations: Yes, all per litter (foetal sex, body weight of live foetuses and presence of external congenital abnormalities)
- Soft tissue examinations: Yes, one-third of foetuses per litter
- Skeletal examinations: Yes, two-thirds of foetuses per litter
- Head examinations: No data - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- -
- Description (incidence and severity):
- -
- Mortality:
- no mortality observed
- Description (incidence):
- -
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- -
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- -
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- -
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- -
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- -
- Haematological findings:
- not specified
- Description (incidence and severity):
- -
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- -
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- -
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- -
- Immunological findings:
- not specified
- Description (incidence and severity):
- -
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- -
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- -
- Neuropathological findings:
- not specified
- Description (incidence and severity):
- -
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- -
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- -
- Other effects:
- no effects observed
- Description (incidence and severity):
- -
- Details on results:
- --
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- -
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- -
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- -
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- -
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- -
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- -
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- -
- Other effects:
- no effects observed
- Description (incidence and severity):
- -
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal survival. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no effects
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- -
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- -
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- -
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- -
- Changes in postnatal survival:
- no effects observed
- Description (incidence and severity):
- -
- External malformations:
- no effects observed
- Description (incidence and severity):
- -
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- -
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- -
- Other effects:
- no effects observed
- Description (incidence and severity):
- -
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on foetal 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. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity, no effects
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- NOAEL (maternal toxicity) > 50 mg/kg bw (nominal concentration)
NOAEL (teratogenicity) > 50 mg/kg bw (nominal concentration)
The administration of up to 50 mg/kg bw of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or foetal 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.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reference is considered reliable with restrictions (conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001)) Restrictions/deviation/deficiencies in comparison to OECD TG 414: - purity of the test substance was not stated - test substance should be administered until the day prior to scheduled caesarean section. In this study the dosing was stopped five days before caesarean section. - body weight was neither recorded on the first day of dosing nor at least every 3 days during the dosing period. - food consumption was not recorded at three-day intervals and did not coincide with days of body weight determination. Food consumption appeared to be part of the clinical observations conducted daily. - gross pathological examination of the females consisted only of the examination of the urogenital tract. - uteri of non-pregnant females were not further examined (e.g. by ammonium sulfide staining) to confirm the non-pregnant status - gravid uteri including the cervix were not weighed. - whereas commonly approximately one-half of each litter is prepared and examined for skeletal alterations and the remainder for soft tissue alterations, in this study instead one-third of each litter was prepared for soft tissue alterations and two-thirds for skeletal tissue alterations. - data on clinical signs were not provided. - age and individual weight of the animals were not given - no analysis of dose administered - data on number and percent of pre- and post-implantation losses were not given
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001). For details on deviations/deficiencies see technical dossier.
- GLP compliance:
- not specified
- Remarks:
- GLP was not compulsory at time of study conduct
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Wistar derived stock
- Age: adult
- Weight (average per dose level; day 0 of gestation; pregnant dams): control group: 241 g; 0.5 mg/kg: 234 g; 2.3 mg/kg: 339 g; 11.0 mg/kg: 242 g; 50.0 mg/kg: 237 g; positive control: 241 g
- Housing: individually housed in mesh bottom cages in temperature and humidity-controlled quarters
- Diet (ad libitum)
- Water (ad libitum): fresh tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was administered as a water solution; 1.0 mL/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: females were mated with young adult males
- Proof of pregnancy: vaginal sperm plug referred to as day 0 of gestation - Duration of treatment / exposure:
- Day 6 through Day 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
- Dose / conc.:
- 0 other: mg Sn/kg diet
- Dose / conc.:
- 2.3 other: mg Sn/kg diet
- Dose / conc.:
- 11 other: mg Sn/kg diet
- Dose / conc.:
- 50 other: mg Sn/kg diet
- No. of animals per sex per dose:
- Treatment groups: 24 mated females (22 - 24 pregnant females)
Control group: 24 mated females (20 pregnant females) - Control animals:
- yes, sham-exposed
- Details on study design:
- - Positive control: 250 mg/kg aspirin (24 mated females received the positive control; 24 females were pregnant)
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: appearance and behaviour with particular attention to food consumption and weight
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 11, 15, and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: urogenital tract - 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: Yes
- Number of implantation sites: Yes
- Number of resorption sites: Yes
- Numbers of live and dead foetuses were recorded - Fetal examinations:
- - External examinations: Yes, all per litter (foetal sex, body weight of live foetuses and presence of external congenital abnormalities)
- Soft tissue examinations: Yes, one-third of foetuses per litter
- Skeletal examinations: Yes, two-thirds of foetuses per litter
- Head examinations: No data - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
- 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
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- 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
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects: no effects
Details on maternal toxic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal survival. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity, no effects observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on foetal 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. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity, no effects observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- NOAEL (maternal toxicity) > 50 mg/kg bw (nominal concentration)
NOAEL (teratogenicity) > 50 mg/kg bw (nominal concentration)
The administration of up to 50 mg/kg bw of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or foetal 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.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reference is considered reliable with restrictions (conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001)) Restrictions/deviation/deficiencies in comparison to OECD TG 414: - purity of the test substance was not stated - test substance should be administered until the day prior to scheduled caesarean section. In this study the dosing was stopped four days before caesarean section. - body weight was neither recorded on the first day of dosing nor at least every 3 days during the dosing period. - food consumption was not recorded at three-day intervals and did not coincide with days of body weight determination. Food consumption appeared to be part of the clinical observations conducted daily. - gross pathological examination of the females consisted only of the examination of the genital tract. - uteri of non-pregnant females were not further examined (e.g. by ammonium sulfide staining) to confirm the non-pregnant status - gravid uteri including the cervix were not weighted. - whereas commonly approximately one-half of each litter is prepared and examined for skeletal alterations and the remainder for soft tissue alterations, in this study instead one-third of each litter was prepared for soft tissue alterations and two-thirds for skeletal tissue alterations. - age and individual weight of the animals were not given - no analysis of dose administered - data on clinical signs were not provided . - data on number and percent of pre- and post-implantation losses were not given
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001). For details on deviations/deficiencies see technical dossier.
- GLP compliance:
- not specified
- Remarks:
- GLP was not compulsory at time of study conduct
- Species:
- hamster, Syrian
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - golden hamster from an outbred strain
- Age: adult
- Weight (average per dose level; day 0 of gestation; pregnant dams): control group: 134.2 g; 0.5 mg/kg: 127.0 g; 2.3 mg/kg: 133.6 g; 11.0 mg/kg: 135.8 g; 50.0 mg/kg: 134.8 g; positive control: 134.2 g
- Housing: individually housed in mesh bottom cages in temperature and humidity-controlled quarters
- Diet (ad libitum)
- Water (ad libitum): fresh tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was administered as a water solution; 1.0 mL/kg bw - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused: females were mated with mature males
- M/F ratio per cage: 1 male / 1 female
- Proof of pregnancy: appearance of motile sperm in vaginal smear referred to as day 0 of gestation - Duration of treatment / exposure:
- Day 6 through Day 10 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 14 days
- No. of animals per sex per dose:
- Treatment groups: 22 mated females (20 - 21 pregnant females)
Control group: 22 mated females (21 pregnant females) - Control animals:
- yes, sham-exposed
- Details on study design:
- - Positive control: 250 mg/kg aspirin (22 mated females received the positive control; 22 females were pregnant)
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: appearance and behaviour with particular attention to food consumption
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 8, 10, and 14 of gestation period
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- Organs examined: genital tract - 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: Yes
- Number of implantation sites: Yes
- Number of resorption sites: Yes
- Numbers of live and dead foetuses were recorded - Fetal examinations:
- - External examinations: Yes, all per litter (foetal sex, body weight of live foetuses and presence of external congenital abnormalities)
- Soft tissue examinations: Yes, one-third per litter
- Skeletal examinations: Yes, two-thirds per litter
- Head examinations: No data - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant hamster for 5 consecutive days had no clearly discernible effect on nidation or on maternal survival. - Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 31 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- tin, recalculated from the value of tin chloride
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The administration of up to 50 mg/kg bw of the test material to pregnant hamster for 5 consecutive days had no clearly discernible effect on foetal 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. - Dose descriptor:
- NOAEL
- Effect level:
- > 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 31 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- tin, recalculated from the value of tin chloride
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- NOAEL (maternal toxicity) > 50 mg/kg bw (nominal concentration)
NOAEL (teratogenicity) > 50 mg/kg bw (nominal concentration)
The administration of up to 50 mg/kg bw of the test material to pregnant hamster for 5 consecutive days had no clearly discernible effect on nidation or on maternal or foetal 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.
Data source
Reference
- Reference Type:
- publication
- 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)
- Version / remarks:
- Conduct of study prior to establishment of current test guidelines, but the conduct of the study is otherwise equivalent or similar to OECD 414 (2001). For details on deviations/deficiencies see technical dossier.
- GLP compliance:
- not specified
- Remarks:
- GLP was not compulsory at time of study conduct
- Limit test:
- no
Test material
- Reference substance name:
- Tin dichloride
- EC Number:
- 231-868-0
- EC Name:
- Tin dichloride
- Cas Number:
- 7772-99-8
- Molecular formula:
- Cl2Sn
- IUPAC Name:
- Tin dichloride
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-33 (Stannous chloride)
- Physical state: white crystalline material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: dutch-belted
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age: adult
- Weight (average per dose level; day 0; pregnant dams): control group: 1.99 kg; 0.42 mg/kg: 2.17 kg; 1.90 mg/kg: 2.35 kg; 8.90 mg/kg: 2.27 kg; 41.5 mg/kg: 2.42 kg: positive control: 2.39 kg
- Housing: individually housed in mesh bottom cages in temperature and humidity-controlled quarters
- Diet (ad libitum)
- Water (ad libitum): fresh tap water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was administered as a water solution. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
On Day 0, each doe was given an injection of 0.4 mL of human chorionic gonadotropin (400 IU) via the marginal ear vein. Three hours later, each doe was inseminated artificially with 0.3 mL of diluted semen from a proven donor buck using approximately 20 x 10^6 motile sperm according to the procedure described by Vogin et al (Pharmacologist 11, 282 (1969)). - Duration of treatment / exposure:
- Day 6 through Day 18
- Frequency of treatment:
- daily
- Duration of test:
- 29 days
- No. of animals per sex per dose:
- Treatment groups: 15 - 17 mated females (11 - 12 pregnant females)
Control group: 14 mated females (10 pregnant females) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Positive control: 2.5 mg/kg 6-aminonicotinamide dosed on Day 9 (17 mated females received the positive control; 12 females were pregnant)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: appearance and behaviour with particular attention to food consumption and weight
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 12, 18, and 29 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: urogenital tract - 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: Yes
- Number of implantation sites: Yes
- Number of resorption sites: Yes
- Numbers of live and dead foetuses were recorded - Fetal examinations:
- - External examinations: Yes, all per litter (foetal sex, body weight of live foetuses and presence of external congenital abnormalities)
The live foetuses of each litter were then placed in an incubator for 24 hours for the evaluation of neonatal survival. All surviving pups were sacrificed, and all pups were further examined as follows:
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No data - Statistics:
- no data
- 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:
The administration of up to 41.5 mg/kg bw of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal survival.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 41.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 26 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- tin, recalculated from the value of tin chloride
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The administration of up to 41.5 mg/kg bw of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on foetal 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.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 41.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 26 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- tin, recalculated from the value of tin chloride
- 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:
- NOAEL (maternal toxicity) > 41.5 mg/kg bw (nominal concentration)
NOAEL (teratogenicity) > 41.5 mg/kg bw (nominal concentration)
The administration of up to 41.5 mg/kg bw of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal or foetal 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.
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