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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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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:
1995
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

Constituent 1
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
Constituent 2
Reference substance name:
Potassium butyl xanthate
IUPAC Name:
Potassium butyl xanthate
Test material form:
other: orally or as air dust

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