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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from 3rd to 17th August 1994
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Reference substance name:
Tin dioxide
EC Number:
EC Name:
Tin dioxide
Cas Number:
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
Identity: anhydrous stannic oxide (SnO2)
Chemical name: anhydrous stannic oxide
Appearance: white powder
Storage conditions: room temperature in the dark
Expiry date: assumed to be stable for at least 6 months from date of arrival at the laboratory.
Purity: 99.85%
Data received: 19 July 1994
Supplier: International Tin Research Institute

Test animals

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.

Administration / exposure

Route of administration:
oral: gavage
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.
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:
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.
no data

Results and discussion

Effect levels
Dose descriptor:
other: LD1
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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:

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The acute lethal oral dose to rats of Anhydrous stannic oxide (Sn02) was found to be greater than 2.0 g/kg bodyweight.