Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.