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Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
not specified
Limit test:
no
Species:
rat
Details on oral exposure:
4 months
Dose / conc.:
10 mg/kg bw (total dose)
Dose descriptor:
LOAEL
Effect level:
10 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
clinical biochemistry
Critical effects observed:
yes
Lowest effective dose / conc.:
10 mg/kg bw (total dose)
System:
haematopoietic
Treatment related:
yes
Relevant for humans:
not specified

During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, lossof hair and dermatitis. Loss of weight and increase in blood sugar and cholesterolwere observed later. Convulsions and paralysis of the extremities were observed insome animals from week 9 of administration. Some animals died during theadministration

Conclusions:
Findings were included central nervous system, liver and spleen effects.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
10 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
30 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data on related xanthate provided as supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
GLP compliance:
not specified
Limit test:
no
Species:
dog
Strain:
Beagle
Sex:
male
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
30-day
Frequency of treatment:
6 hrs daily, 5 days a week for a total of 20 exposures in 1 month
Dose / conc.:
100 mg/m³ air (nominal)
Dose / conc.:
800 mg/m³ air (nominal)
No. of animals per sex per dose:
2
Control animals:
yes
Observations and examinations performed and frequency:
Daily
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Dose descriptor:
LOEC
Effect level:
100 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Hepatotoxic effects
Critical effects observed:
not specified
Conclusions:
The results of this study indicate that potassium amyl xanthate has an adverse effect on the the liver in dogs. There were no treatment-related changes in the haematological or urinalysis values in any of the animals.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEC
100 mg/m³
Study duration:
subacute
Species:
dog
Quality of whole database:
Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the absence of reliable information, the data forpotassium amyl xanthate (CAS# 2720-73-2) may be used as a surrogate for sodium ethyl xanthate (CAS# 140-90-9).

The target sites for sodium ethyl xanthate, and other xanthates are the central nervous system, liver and kidneys. The adverse effects seen in the toxicity studies could be due to the xanthates (such as sodium ethyl xanthate), their decomposition products or a combination of both.

There is no human information available concerning reproductive toxicity for xanthates(, CHEMINFO ,2004, ,Chemical Profiles Created by CCOHS , www.ccohs.ca).


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other; neurologic: central nervous system

Repeated dose toxicity: inhalation - systemic effects (target organ) digestive: liver

Justification for classification or non-classification