Registration Dossier

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. 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.

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

Reference
Name:
Unnamed
Type:
Constituent
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. 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.
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.