Dimethyl sulfoxide

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Materials and methods

Principles of method if other than guideline:

Type: other: reproductive organs toxicity
Method: other: OECD guide-line 413

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl sulfoxide

EC Number:

200-664-3

EC Name:

Dimethyl sulfoxide

Cas Number:

67-68-5

Molecular formula:

C2H6OS

IUPAC Name:

dimethyl sulfoxide

Test material form:

liquid

Details on test material:

Chemical registery number : CAS 67-68-5 / EC 200-664-3
Chemical name : dimethyl sulfoxide (DMSO)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

6 hours/day, 7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0.310, 0.964 and 2.783 mg/l
Basis:

Control animals:

yes, concurrent vehicle

Details on study design:

Duration of test: 13 weeks

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

> 2.783 mg/L air

Sex:

male/female

Basis for effect level:

other: No effects in oestrus cycle and sperm investigations after 90 D inhalation

Observed effects

No treatment related effects were observed up to 2.783 mg/l

Applicant's summary and conclusion

Executive summary:

The potential toxicity of Dimethylsulfoxide (DMSO) was evaluated following repeated inhalation administration for 13 weeks, according to OECD Guideline and US EPA OPPTS and in compliance with GLP.

Three groups of rats (10 males and 10 females) of the Crl:CD®BR strain were exposed to a vapour or vapour/liquid droplet atmosphere generated from pure (100%) DMSO, 6 hours a day, 7 days a week for 13 weeks using a snout only exposure system. A fourth group, acting a control was exposed to air only. An additional 10 male and 10 female rats concurrently exposed at the Control and High dose levels were restrained following the final exposure for the further 74 weeks of withdrawal (recovery) to assess the reversibility of any adverse findings. Satellite groups of rats were exposed concurrently 6 hours a day for 28 consecutive days.

 

The oestrus cycle of female rats was monitored. Following sacrifice rats were submitted to detailed macroscopic examinations followed by preservation of tissues and subsequent histopathological examination. Male rats were submitted to seminological investigations.

There were no findings on gross pathology that were considered to be attributable to exposure to DMSO.

There were no differences on oestrus cycle or seminology between control and test groups considered to be attributable to exposure to DMSO. Results of the plaque cell-forming assay suggest that DMSO has no reprotoxic findings that were treatment related. In consequence, the NOAEC was 2.783 mg/l for systemic toxicity.