Registration Dossier
Registration Dossier
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EC number: 205-440-9 | CAS number: 140-90-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 months
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Some limitations in terms of details in the Australian Government review, but allows for classification
The potassium salt of these xanthates is considered suitable as a source of data for the corresponding sodium salt
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.
Testing on gastric hydrolysis demonstrate rapid (exothermic) hydrolysis under gastric conditions meaning that the animals will be exposed to hydrolysis products only.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Full Public Report Sodium Ethyl Xanthate Priority Existing Chemical No. 5
- Author:
- Australian Government Publishing Service Canberra
- Year:
- 1 995
- Bibliographic source:
- Australian Government Publishing Service Canberra
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Extended to 4 months
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Potassium O-butyl dithiocarbonate
- EC Number:
- 212-808-2
- EC Name:
- Potassium O-butyl dithiocarbonate
- Cas Number:
- 871-58-9
- IUPAC Name:
- potassium O-butyl dithiocarbonate
- Reference substance name:
- Potassium butyl xanthate
- IUPAC Name:
- Potassium butyl xanthate
- Test material form:
- other: orally or as air dust
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on oral exposure:
- 4 months
Doses / concentrations
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:10 mg/kgBasis:no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Haematological findings:
- effects observed, treatment-related
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
- Organ:
- liver
- spleen
Applicant's summary and conclusion
- Conclusions:
- Findings were included central nervous system, liver and spleen effects.
- Executive summary:
During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, loss of hair and dermatitis. Loss of weight and increase in blood sugar and cholesterol were observed later. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration
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