Sodium O-isobutyl dithiocarbonate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1966

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.8700 (Subchronic Oral Toxicity Test)

Principles of method if other than guideline:

potassium butyl xanthate was administered orally (10 mg/kg) or as air dust to rats, rabbits and dogs for 4 months.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

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:

solid: compact

Details on test material:

- Name of test material (as cited in study report):potassium butyl xanthate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

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)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

4 months

Frequency of treatment:

7 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
10 mg/kg bw/day
Basis:
actual ingested

Control animals:

yes

Details on study design:

potassium butyl xanthate was administered orally (10 mg/kg) or as air dust 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.

Positive control:

no

Examinations

Observations and examinations performed and frequency:

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.

Other examinations:

No

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. Some animals died during the administration.

Mortality:

mortality observed, treatment-related

Description (incidence):

tachypnoea, cyanosis, loss of hair and dermatitis. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

. Loss of weight and increase in blood sugar and cholesterol were observed later.

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

Potassium butyl xanthate was administered orally (10 mg/kg) or as air dust 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.

Effect levels

Dose descriptor:

NOAEL

Effect level:

10 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Under the condition of this study, for a period of 4 months 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.
No NOAEL was identified.

Executive summary:

Potassium butyl xanthate was administered orally (10mg/kg) or as air dust to rats, rabbits and dogs for 4 months. 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.