Bis(isopropyl) thioperoxydicarbonate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

Only over a 2 week period

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

di-isopropyl xanthogen disulphide (DIXD)

IUPAC Name:

di-isopropyl xanthogen disulphide (DIXD)

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: 1:16 acetone:peanut oil as 10%

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

2 weeks

Frequency of treatment:

5 times a week

No. of animals per sex per dose:

6 males

Control animals:

yes

no

Details on study design:

The test material was administered daily by stomach tube as a 10% solution in acetone:peanut oil (1:10) to each of six ChR-CD male rats, 5 times a week for 2 weeks. Groups of 3 animals, along with controls, were killed 5 hours and 10 days after the last treatment.

Positive control:

No

Examinations

Observations and examinations performed and frequency:

First week - severe weight loss for 3 days, excessive urination, discomfort, irritability, pallor and cyanosis.
Second week - weight gain inferior to controls, other signs same but less severe.
Observation period - weigh gain parallel to controls, no toxic signs

Sacrifice and pathology:

After 10h treatment - albumin in kidney, depression of sprmatogenesis.
After 10-day observation period - no pathological changes attributable to the compound.

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

First week - severe weight loss for 3 days, excessive urination, discomfort, irritability, pallor and cyanosis

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

Only lasted 3 days as severe weight loss but after 2 weeks weight pain parallel to controls.

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

effects observed, treatment-related

Description (incidence and severity):

After 10th treatment - albumin in kidney but not observed after 10-day observation.

Urinalysis findings:

effects observed, treatment-related

Description (incidence and severity):

Excessive urination in first week - after second week - signs less severe.

Behaviour (functional findings):

effects observed, treatment-related

Description (incidence and severity):

First week - irritability and discomfort. After second week - signs less severe.

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

>= 300 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

behaviour (functional findings)

body weight and weight gain

clinical signs

haematology

urinalysis

Target system / organ toxicity

Key result

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

An NOAEL of 300mg/kg/day was observed over the 2 week period.