Sodium O-isobutyl dithiocarbonate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

other: published data

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Carbon disulphide is both a reagent in the manufacture, as well as a decomposition product of xanthates. SIBX readily decomposes to carbon disulphide, especially in the presence of moisture/water. Therefore, the health effects of carbon disulphide (CS2) need to be considered in the assessment of SIBX.

Data source

Reference

Reference Type:

publication

Title:

Carbon disulphide induced impairments in male reproductive system in rats.

Author:

Patel KG, Gautam AK, and Vaghasia YV

Year:

1999

Bibliographic source:

Ind. J. Physiol. & Allied Sci., 53(1): 22-28

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

CS2 was administer intraperitoneally to male rats in order to examine alterations in reproductive hormones, testicular tissue and epididymis.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Carbon disulphide

EC Number:

200-843-6

EC Name:

Carbon disulphide

Cas Number:

75-15-0

Molecular formula:

CS2

IUPAC Name:

dithioxomethane

Test material form:

solid: compact

Details on test material:

Carbon disulphide is both a reagent in the manufacture, as well as a decomposition product of xanthates. Reaction mass of SIBX readily decomposes to carbon disulphide, especially in the presence of moisture/water. Therefore, the health effects of carbon disulphide (CS2) need to be considered in the assessment of Reaction mass of SIBX.
- Name of test material (as cited in study report): carbon disulfide
- Molecular formula (if other than submission substance): CS2
- Physical state: liquid
- Analytical purity: 99.99%
- Stability under test conditions: yes
- Storage condition of test material: temperature room

Test animals

Species:

rat

Strain:

other: Charles-Foster

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

cotton seed oil

Details on exposure:

Different dosages of CS2 dissolved in maruti micro reined cotton seed oil viz. 25,50,100 and 200 mg/kg body weight daily were administered intraperitoneally over a period of 30 days

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

30 days

Frequency of treatment:

daily

Duration of test:

30 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 50, 100 mg
Basis:
nominal conc.

No. of animals per sex per dose:

10

Control animals:

yes, concurrent no treatment

yes, concurrent vehicle

Details on study design:

Different dosages of CS2 dissolved in maruti micro reined cotton seed oil viz. 25,50,100 and 200 mg/kg body weight daily were administered intraperitoneally over a period of 30 days. Pathomorphological changes and functional impairments were observed in male reproductive organs. Significant decrease in serum testosterone levels and marked degenerative changes in testicular tissue were observed specially in 100 and 200 mg/kg CS2 treated rats.

Results and discussion

Effect levels

Dose descriptor:

LOAEC

Effect level:

25 mg/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: decreased serum testosterone levels, histologic findings

Observed effects

decreased serum testosterone levels, histologic findings

Any other information on results incl. tables

Table 1: Effects of different doses of CS2 on serum testosterone levels

and tissue weights of rats.

Dose (mg/kg bw)	Testosterone (ng/dl)	Testis (mg)	Epididymis (mg)
Control	540±37.32	1.35±0.08	33±2
Vehicle control	504.5±52.22	1.32±0.07	36.4±1.4
25	224.3±17.35*	1.27±0.07	35.3±2.2
50	207.77±23.32*	1.32±0.13	33.2±2.3
100	84±29.88*	1.37±0.12	32.7±2.4
200	31.6±3.09*	1.34±0.06	33.3±0.3

*p < 0.001

CS2 exposure exerted reductions in body weights, that were remarkable after treatment with the 2 highest doses. Exposure to all concentrations resulted in a significant dose-dependent decline in serum testorone levels, while no alterations were recorded in the testicular and epididymal weights. The histologic examinations revealed no changes in the epididymis. The testis were evidently affected with ' thickening of peritubular membrane, rupturing of seminiferous basement membrane, degeneration and disorganization of spermatogonial cells and less number or absence of sperms in the lumen'. Such effects were much more pronounced at the last two groups.

 

Applicant's summary and conclusion

Conclusions:

The present observations clearly indicate effects of CS2 on the male reproduction system. Nonetheless, the relevance of the study is questionable due to the invasive route of exposure.
Carbon disulphide is both a reagent in the manufacture, as well as a decomposition product of xanthates. SIBX readily decomposes to carbon disulphide, especially in the presence of moisture/water. Therefore, the health effects of carbon disulphide (CS2) need to be considered in the assessment of SIBX.

Executive summary:

Deleterious effects of short term exposure of CS2 were investigated on reproductive organs of male albino rats. Different dosages of CS2 dissolved in maruti micro reined cotton seed oil viz. 25,50,100 and 200 mg/kg body weight daily were administered intraperitoneally over a period of 30 days. Pathomorphological changes and functional impairments were observed in male reproductive organs. Significant decrease in serum testosterone levels and marked degenerative changes in testicular tissue were observed specially in 100 and 200 mg/kg CS2 treated rats. Diminution of serum testosterone levels and degeneration in Leydig ceils indicate a definite alterations in the process of steroidogenesis after CS2treatment. Pronounced changes in testicular structure indicated plausible effect on sper­matogenesis. Further, androgenic deficiency, evident by decrease in testosterone level after CS2 treatment produced alterations in epididymis.