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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:
Read-across from potassium salt
Some limitations in terms of details in the Australian Government review, but allows for classification
The potassium salty 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.
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 n-butyl xanthate
IUPAC Name:
Potassium n-butyl xanthate
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
ENVIRONMENTAL CONDITIONS
After an adequate acclimatisation period (at least five days), the animals were barrier maintained (full-barrier) in air conditioned rooms under the following conditions: temperature: 22 ± 3 °C, relative humidity: 55 ± 10%, artificial light, sequence being 12 hours light, 12 hours dark, air change: 10 x / hour, free access to Altromin 1324 maintenance diet, free access to tap water, sulphur acidified to a pH of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically), housed individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
4 months
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
At least weekly checks to confirm stability and achieved concentrations
Duration of treatment / exposure:
4 months
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
5 mg/kg bw/day (nominal)
Dose / conc.:
10 mg/kg bw/day (nominal)
Dose / conc.:
15 mg/kg bw/day (nominal)
No. of animals per sex per dose:
20 animals per sex
Control animals:
yes, concurrent no treatment
Details on study design:
Potassium butyl xanthate was administered orally (0,5, 10 and 15 mg/kg) to rats, rabbits and dogs for 4 months. 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.

Examinations

Observations and examinations performed and frequency:
Daily clinical observations.
At least weekly body weights.
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.
Sacrifice and pathology:
Gross necropsy and pathology performed
Statistics:
Yes, as applicable

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
tachypnoea, cyanosis, loss of hair and dermatitis. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration.
Mortality:
mortality observed, treatment-related
Description (incidence):
Some animals died during the administration.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Loss of weight
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Endocrine findings:
not specified
Urinalysis findings:
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
A slight decrease in testes weight in highest group males was observed when compared to control animals, but not statistically significant.
Individual animals in different groups showed other adverse effects, but not considered treatment related and not considered significant.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Most changes minor and of limited significance.
tachypnoea, cyanosis, loss of hair and dermatitis
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Individual animals in different groups showed some adverse effects, but not considered treatment related and not considered significant.
Histopathological findings: neoplastic:
no effects observed
Details on results:
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.

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