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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 242-159-0 | CAS number: 18282-10-5
- 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
Endpoint summary
Administrative data
Description of key information
Oral, LD50 > 2,000 mg/kg bw, rat (EU Method B1)
Inhalation, LC50 > 2.04 mg/L, rat (OECD 403, EU method B2)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 3rd to 17th August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Equal numbers of healthy male and female CD rats of Sprague-Dawley origin (Hsd/Ola:SpragueDawley(CD)) were obtained from Harlan Olac Ltd., Bicester, Oxon, England.
They were in the weight range of 97 to 114 g and approximately four to seven weeks of age prior to dosing (Day 1) in the main study. All the rats were acclimatised to the experimental environment for a period of six days prior to the start of the main study.
The rats were allocated without conscious bias to cages within the treatment group. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors in Building R14 Room 6.
A standard laboratory rodent diet and drinking water were provided ad libitum.
Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The batch(es) of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organisms.
Animal room temperature was set to achieve a temperature of 22 ± 3°C.
Relative humidity was not controlled but was anticipated to be in the range 30 - 70% R.H.
Permanent daily recordings of these parameters was made and these are archived with other Department raw data. Any slight deviation in temperature and humidity that may have occurred had no impact on the study in the opinion of the Study Director. Air exchange was maintained at 10 to 15 air changes per hour and lighting controlled by means of a time switch to provide 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period. - Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose
- Details on oral exposure:
- The appropriate dose volume of the test substance was administered to each rat by oral gavage using a syringe and plastic catheter (8 choke).
The day of dosing was designated Day 1. - Doses:
- Anhydrous stannic oxide (SnO2) was prepared at a concentration of 20% w/v in 1% w/v aqueous methylcellulose and administrated at a volume of 10 ml/Kg bodyweight.
- No. of animals per sex per dose:
- five males and five females was given a single dose by gavage of the test substance, formulated in 1% acqueous methylcellulose, at a dose level of 2.0 g/Kg bodyweight.
- Control animals:
- no
- Details on study design:
- Anhydrous stannic oxide (Sn02) was prepared at a concentration of 20% w/v in 1 % w/v aqueous methylcellulose and administered at a volume of 10 mI/kg bodyweight.
The test substance was prepared on the day of dosing.
The absorption of the test substance was not determined
A group of ten rats (five males and five females) was treated at 2.0 g/kg body weight.
No control animals were included in this study. - Statistics:
- no data
- Sex:
- male/female
- Dose descriptor:
- other: LD1
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral dose of Anhydrous stannic oxide (Sn02) at 2.0 g/kg bodyweight.
- Clinical signs:
- other: Piloerection was observed in all rats within five minutes of dosing. This sign persisted and was accompanied at later intervals on Day 1 only by abnormal body carriage (hunched posture). Recovery of all rats, as judged by external appearance and behaviour
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal oral dose to rats of Anhydrous stannic oxide (Sn02) was found to be greater than 2.0 g/kg bodyweight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The main assumption for this read across approach is that the source substance ionic Tin (IV) and the target substance Tin (IV) dioxide NP have a common moiety (Tin ion).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to test item sections for details.
3. ANALOGUE APPROACH JUSTIFICATION
A reliable Acute Oral Toxicity Study is available for the source substance ionic Tin (IV), showing that the substance has no acute toxicity via Oral route (The acute lethal oral dose to rats of Anhydrous stannic oxide (SnO2) was found to be greater than 2.0 g/kg bodyweight).
Since the target and the source substance dissociate to the same ion, both target and read-across substance, do share the same toxicological mechanisms and the effects of the target substance is predicted to be equal to the effects of the source substance.
The dissolving part of Tin (IV) dioxide contributes mostly to its toxicity (De Groot et al, 1973). The common compound ionic Tin (IV) is solely responsible for the absence or presence of effects. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Sex:
- male/female
- Dose descriptor:
- other: LD1
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with international recognized guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: Spangue-Dawley derived, albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Number of Animals: 10
- Sex: 5 Males and 5 Females. The females assigned to test were nulliparous and non- pregnant.
- Species/Strain: Rat/Sprague-Dawley derived, albino.
- Age/Body weight: Young adult (10-11 weeks)/males 273-294 grams and females 185- 212 grams at experimental start.
- Source: Received from Harlan Laboratories, Inc. on March 14, 2012.
Enviromental conditions:
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Litter paper was placed beneath the cage and was changed at least three times per week.
- Animal Room Temperature and Relative Humidity Ranges: 20-23ºC and 46-58%, respectively.
- Animal Room Air Changes/Hour: 13. Airflow measurements are evaluated regularly and the records are kept on file at Product Safety Labs.
- Photoperiod: 12-hour light/dark cycle
- Acclimation Period: 14 days
- Food: Harlan Teklad Global 16% Protein Rodent Diet #2016 was supplied ad libitum, except during exposure.
- Water: Tap water was supplied ad libitum by an automatic water dispensing system except during exposure.
- Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: water
- Details on inhalation exposure:
- Nose-Only Exposure Chamber: A nose-only inhalation chamber with an internal volume of approximately 28 liters (Nose-Only Inhalation Chamber, ADG Developments LTD) was used for exposure. Animals were individually housed in polycarbonate holding tu exposure. The base unit terminates the chamber with a 0.5-inch diameter tube for discharged air.
Air Supply: Approximately 30.0 liters per minute (Lpm) of filtered air was supplied by an air compressor (Powerex Model: SES05) to the spray atomization nozzle. An additional 6.0 Lpm of compressed mixing air from the air compressor was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Compressed airflow was measured with a Mass Flowmeter (Omega, Model #FMA-5613). Chamber airflow was monitored throughout the exposure period and recorded periodically. Mean airflow was 36.0 Lpm. Based on the volume of the inhalation chamber, this airflow provided approximately 77 air changes per hour during the study.
Ambient Conditions: The exposure tube temperature and relative humidity ranges during exposure were 20-21ºC and 16-19%, respectively. The room temperature and relative humidity ranges during exposure were 20-21ºC and 29-30%, respectively. A humidifier was used during exposure. The measurements inside the exposure tube and the room conditions were made with a Temperature-Humidity Monitor (Fisher Scientific, 11-661-18). Temperature and relative humidity values were recorded every 15 minutes for the first hour of exposure and every 15 or 30 minutes thereafter.
Atmosphere Generation: The test atmosphere was generated using a ¼ inch JCO atomizer, (Spraying Systems Co.), FC3 fluid cap (Robert Miller Associates) and 70SS air cap (Spraying Systems Co.). Compressed generator/mixing air were supplied at 30/30 psi. The test substance was metered to the atomization nozzle through size 16 Tygon tubing, using a peristaltic pump (Master Flex, Model #7520-35).
Chamber Concentration Measurements: Gravimetric samples were withdrawn at six intervals from the breathing zone of the animals. Samples were collected using 37 mm glass fiber filters (GF/B Whatman) in a filter holder attached by ¼ inch Tygon tubing to a vacuum pump (Westech). The filter was weighed before and after collection to determine the mass collected. The collections were carried out for 1 minute at airflows of 4 Lpm. Sample airflows were measured using a Mass Flowmeter (Aalborg, Model #GFC-17). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric analysis + flowmeter analysis
- Duration of exposure:
- > 4 h
- Remarks on duration:
- the exposure period was extended of 4 min beyond 4 hours in order to reach an equilibrium in the chamber.
- Concentrations:
- the dry weight gravimetric and nominal chamber concentrations were 2.04 mg/L and 236.7 mg/L, respectively. 2.4 mg/L was the highest chamber concentration achieved.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Prior to initiation of the full inhalation study, pre-test trials were conducted to establish generation procedures to achieve, to the extent possible, the desired chamber concentration (2.0 mg/L) and desired particle size distribution (mass median aerodynamic diameter between 1 and 4 µm).
Prior to conducting pre-test trials, attempts were made at generating the test atmosphere as a dust. However, the test substance as a powder clogged all dust generator equipment used during preliminary testing. Therefore, the unground test substance was diluted to a 25% w/w dilution in distilled water for all trials conducted. In addition, it was decided that a dry weight gravimetric measurement procedure was to be used. The exposure procedures and atomization equipment used were based on the results of pre-test trial number 2 which provided a gravimetric concentration of 2.03 mg/L with a mass median aerodynamic diameter of 2.21 µm. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.04 other: mg/L (dry weight)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: the substance was diluted in distilled water at 25% w/w
- Mortality:
- All animals survived exposure to the test atmosphere.
- Clinical signs:
- other: Following exposure four males and all five females exhibited irregular respiration. All affected rats recovered from this symptom by Day 5, and along with the fifth male, appeared active and healthy for the remainder of the observation period.
- Body weight:
- Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 1, 3, 7 and 14 (termination).
Although all rats lost body weight by Day 1 and/or through Day 3, all animals showed a weight gain over the entire study. - Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the single exposure acute inhalation LC 50 of a 25% w/w dilution of Tin dioxide in distilled water is greater than 2.04 mg/L maximum attainable (dry weight) in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2.04 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute toxicity of tin dioxide was evaluated in 1 key oral (gavage) study and in a key inhalational study. The oral study was performed according to the EU Method B1 and the inhalational study according to the OECD Guideline 403. Both the studies were compliant with Good Laboratory Practices (GLP). A study was performed to assess the acute oral toxicity of anhydrous stannic oxide (SnO2) to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Annex to Directive 92/69/EEC, Part B, Method B.l. Acute toxicity (oral). A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, formulated in 1 % w/v aqueous methylcellulose, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths. Clinical signs of reaction to treatment were limited to piloerection and abnormal body carriage (hunched posture). Recovery was complete by Day 3. All rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal oral dose to rats of Anhydrous stannic oxide (SnO2) was found to be greater than 2.0 g/kg bodyweight.
An acute inhalation toxicity test was conducted with rats to determine the potential for Tin dioxide NP to produce toxicity from a single exposure via the inhalation (nose-only exposure) route. Under the conditions of this study, the single exposure acute inhalation LC 50 of a 25% w/w dilution of Tin dioxide in distilled water is greater than 2.04 mg/L maximum attainable (dry weight) in male and female rats. After establishing the desired generation procedures during the pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration and particle size distributions of the test substance were determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure and again on Days 1, 3, 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. The dry weight gravimetric chamber concentration was 2.04 mg/L, the maximum attainable concentration. The mass median aerodynamic diameter was calculated to be 2.7 µm based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler. All animals survived exposure to the test atmosphere. Following exposure four males and all five females exhibited irregular respiration. All affected rats recovered from this symptom by Day 5, and along with the fifth male, appeared active and healthy for the remainder of the observation period. Although all rats lost body weight by Day 1 and/or through Day 3, all animals showed a weight gain over the entire study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Justification for selection of acute toxicity – oral endpoint
Well documented GLP study
Justification for selection of acute toxicity – inhalation endpoint
GLP study in compliance with international recognized guidelines.
Justification for classification or non-classification
The submission substance has a rat acute oral LD50 of greater than 2000 mg/kg bw. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.
The submission substance has a rat acute inhalative 4h LC50 of greater than 2.04 mg/L, the highest chamber concentration that can be obtained. There is no indication that a higher dose would result in acute toxicity. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.
No data is available to address acute dermal toxicity. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.
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.