Registration Dossier
Registration Dossier
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EC number: 260-828-5 | CAS number: 57583-34-3
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 10 rats (males and females) were exposed to an aerosol of the test substance at concentrations of 200, 250, 300, and 350 mg/l/hour, for one hour. The test substance was administered via an atomizer configured to provide droplet sizes of 3-10 microns. After the 1-hour exposure period, animals were observed for 3 weeks, prior to sacrifice and necropsy.
- GLP compliance:
- no
- Test type:
- other: See principles of method section
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- EC Number:
- 260-828-5
- EC Name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- Cas Number:
- 57583-34-3
- Molecular formula:
- C31H60O6S3Sn
- IUPAC Name:
- 2-ethylhexyl 10-ethyl-4-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Advastab TM-181FS
- Lot/batch No.: 25L-180
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- This information was not provided in the report.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Details on inhalation exposure:
- Specific information was not provided
- Analytical verification of test atmosphere concentrations:
- not specified
- Remarks:
- No data provided in the report
- Duration of exposure:
- 1 h
- Concentrations:
- 200, 250, 300, 350 mg/L/hr
- No. of animals per sex per dose:
- 10 animals consisting of both males and females, with the number of each not available
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 3 weeks
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: at least clinical signs, food consumption. - Statistics:
- The acute inhalation LC50 and 95 % (19/20) confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 240 mg/L air
- 95% CL:
- > 212 - < 271
- Exp. duration:
- 1 h
- Mortality:
- Observed mortality (number of deaths/total number tested), by dose level tested:
200 mg/L/hr: 2/10 animals
250 mg/L/hr: 6/10 animals
300 mg/L/hr: 9/10 animals
350 mg/L/hr: 10/10 animals - Clinical signs:
- other: Behavior of the surviving test animals, including food and water consumption and demeanor, remained normal. The lone surviving animal in the 300 mg/l/hr dose group, died on observation day 16.
- Body weight:
- No data
- Gross pathology:
- Gross findings included blood in lungs, dark spleen, pale kidneys, fluid in the chest cavity, and heart failure.
- Other findings:
- Food and water intake, excretions, and demeanor in the colony were all within normal limits.
Any other information on results incl. tables
The slope was 1.22 (1.04-1.43)
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- LC50 240 mg/L/hr
- Executive summary:
Groups of 10 rats, both male and female, inhaled the test material within a closed chamber of known volume. The test material was sprayed into the chamber by means of an atomiser. Animals were observed for 3 weeks.
Gross autopsy findings included: blood in the lungs, dark spleen, pale kidneys, fluid in the chest cavity and heart failure.
The inhalation LC50 was 240 mg/L/h.
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