Dimethyl disulphide

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

other information

Study period:

2006-02-22 to 2006-04-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The objective of this study (WIL-160126) was to determine the critical period of exposure during lactation required to replicate lower pup body weight results at 5, 20 and 80 ppm in a concurrent two-generation reproductive toxicity study in rats (WIL-160122; Nemec, 2006). Although the lower mean body weights and body weight gains noted in the two-generation reproductive toxicity study were occasionally statistically significantly different from the control group, the effects did not occur in an exposurerelated manner. Therefore, the current study (WIL-160126) was conducted to determine if the lower pup body weight effects noted in the two-generation study could be reproduced under conditions of exposure of the F0 adults during discrete periods of F1 postnatal development. As a result, the maternal animals in the current study (WIL-160126) were exposed to the test article at exposure levels of 5, 20 and 80 ppm during 1 of 3 selected exposure periods (lactation days 5-12 [Subset I], 13-20 [Subset II] or 5-20 [Subset III]).

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl disulphide

EC Number:

210-871-0

EC Name:

Dimethyl disulphide

Cas Number:

624-92-0

Molecular formula:

C2H6S2

IUPAC Name:

(methyldisulfanyl)methane

Details on test material:

Source: Odor Tech, Pineville, Louisiana on behalf of Arkema Inc.
Batch no. 05.05.05
Purity: 99.8%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure (if applicable):

whole body

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

yes

Results and discussion

Any other information on results incl. tables

All dams in all 3 subsets survived to the scheduled necropsies on lactation day 21. There were no exposure-related clinical or macroscopic findings noted for the maternal animals at any exposure level in Subsets I, II and III. Lower mean maternal body weight gains with reduced food consumption were observed in the 80 ppm group in Subsets I, II and III during the first week of exposure when compared to the control group. At 20 ppm, lower mean maternal body weight gain and reduced food consumption were noted only on lactation days 5-7 in Subset III; however, the body weight effect at this exposure level was not observed in Subset I or Subset II. Mean maternal body weights, body weight gains and food consumption in the 5 ppm group were unaffected by test article exposure. There were no effects on the number of pups found dead, and there were no clinical or macroscopic findings noted for the F1 pups as a result of maternal exposure at any concentration in Subsets I, II and III. There were no effects on pup body weights when maternal animals were exposed to 5, 20 or 80 ppm dimethyl disulfide during lactation days 5-12 (Subset I), lactation days 13-20 (Subset II) or lactation days 5-20 (Subset III).

Applicant's summary and conclusion

Conclusions:

This study (WIL-160126) was conducted in order to determine if the pup body weight effects noted in the concurrent two-generation study (WIL-160122; Nemec, 2006) at exposure levels of 5, 20 and 80 ppm were a true reflection of toxicity, and was designed to examine whether more abbreviated exposure regimens targeted during lactation or more sustained exposure was necessary to replicate the effect on pup body weights. Based on the results of this study, no effects were noted on pup body weights when dams were exposed to dimethyl disulfide at concentrations of 5, 20 and 80 ppm for 1 week during lactation days 5-12 (Subset I) or lactation days 13-20 (Subset II), or for 2 weeks during lactation days 5-20 (Subset III). Therefore, the body weight effects noted for the F1 pups in the concurrent two-generation study (WIL-160122) at 5, 20 and 80 ppm were not replicated in the current study (WIL-160126) when abbreviated exposure regimens were targeted.