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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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:
no GLP information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: drinking water
Vehicle:
water
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 207 mg/kg bw
Interpretation of results:
GHS criteria not met
Remarks:
EU GHS criteria not met
Conclusions:
The LD50 of tin sulfate was determined to be 2207 mg/kg bw.
Endpoint conclusion
Dose descriptor:
LD50
Value:
2 207 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
endpoint for information only
Qualifier:
according to guideline
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: HsdHan:WIST strain
Sex:
male/female
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5, 1, 0.5 mg/L
No. of animals per sex per dose:
6
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
2 mg/L air
Based on:
test mat.
Remarks:
dust
Exp. duration:
4 h
Remarks on result:
other: calculated LC50 in accordance with OECD 436
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.5 mg/L air
Based on:
test mat.
Remarks:
dust
Exp. duration:
4 h
Remarks on result:
other: at the dose of 0.5 mg/L no mortality was observed
Remarks:
.
Mortality:
All animals treated at a concentration of 5 mg/L died or were killed in extremis. Two males and one female treated at a concentration of 1 mg/L died or were killed in extremis. All animals exposed to a concentration of 0.5 mg/L survived treatment.
Body weight:
All surviving rats showed a loss in body weight during the first week of the observation period. However, all surviving rats gained weight during the second week of the observation period. All surviving rats, except for two females exposed to a concentration of 1 mg/L had reached their pre-exposure body weight by Day 15.
Gross pathology:
Abnormalities noted at necropsy of animals that that died or were killed in extremis during the study were red, dark, mottled or inflated lungs, pale or dark areas on the lungs, gaseous distension of the stomach, red nasal cavity, white substance in the nasal cavity and small and red thymus. No abnormalities were noted at necropsy of animals killed at the end of the study period except for pale or dark foci on the lungs noted in one female treated at a concentration of 0.5 mg/L.
Interpretation of results:
other: Category 4 based on EU GHS criteria
Conclusions:
The test material was classified as Category 4 in respect of its acute inhalation toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
2 mg/L
Physical form:
inhalation: dust / mist

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because skin contact in production and/or use is not likely
Conclusions:
Substance is irritation to dermis, so no animal test allowed in due to animal protection
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Due to the classification Skin Sens 1 intensive risk management measures are in place to avoid significant skin contact. Hence, a study on dermal toxicity is not performed.

Justification for classification or non-classification