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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data available
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Route of exposure not relevant for risk assessment purposes.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Alteration in the Reproductive Patterns of Female Mice Exposed to Xenobiotics.
Author:
Bishop, J.B. et al.
Year:
1997
Bibliographic source:
Fundamental and applied toxicology 40: 191-204

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl sulphate
EC Number:
201-058-1
EC Name:
Dimethyl sulphate
Cas Number:
77-78-1
Molecular formula:
C2H6O4S
IUPAC Name:
dimethyl sulfate
Details on test material:
- Name of test material (as cited in study report): Dimethyl sulphate
No further details are given.

Test animals

Species:
mouse
Strain:
other: SEC x C57BL6)F1 and (101/R1)F1 and (C57BL x C3H/R1)F1
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: (P) 10-12 weeks
No further details are given.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Details on exposure:
no data
Details on mating procedure:
Females were caged individually with an untreated male early in the morning following the day of injection. Breeding pens were checked daily for the presence of newborn mice beginning 18 days following the establishment of mating pairs or following the birth of litter.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
single treatment
Frequency of treatment:
one single injection
Details on study schedule:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
75 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
30-36 females in each treatment and each control
Control animals:
yes
Details on study design:
Offspring were counted and discarded immediately after birth. Initially this procedure was continued until the females stopped producing offspring (>366 days). Female reproductive performance was further characterised by averaging the total number of offspring per female and the number of litters per female.
Criteria for evaluating whether the chemical affected female reproductive performance were based primarily upon these two latter values and/or significant depression of the size of litters in the first or second intervals.
Positive control:
no data

Examinations

Parental animals: Observations and examinations:
Ovarian histology: 10 female mice were given a single i.p. injection at the indicated dose level. 15 days after injection, females were euthanised by cervical dislocation and their ovaries removed. Ovaries from each female were fixed, embedded in paraffin and sections were prepared. After staining, the number of small follicles, medium-sized follicles and large follicles were counted.
Oestrous cyclicity (parental animals):
no data
Sperm parameters (parental animals):
no data
Litter observations:
no data
Postmortem examinations (parental animals):
no data
Postmortem examinations (offspring):
no data
Statistics:
no data
Reproductive indices:
no data
Offspring viability indices:
no data

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
effects observed, treatment-related

Details on results (P0)

DMS significantly reduced female reproductive performance.

Effect levels (P0)

open allclose all
Dose descriptor:
other: results for offspring
Basis for effect level:
other: No NOAEL was determined. The size of litters was slightly but significantly lower and were associated with small follicles.
Remarks on result:
not measured/tested
Remarks:
Effect level not specified Generation not specified (migrated information)
Dose descriptor:
other: results for maternal animals
Basis for effect level:
other: No NOAEL was determined. DMS significantly reduced female reproductive performance.
Remarks on result:
not measured/tested
Remarks:
Effect level not specified Generation not specified (migrated information)

Results: F1 generation

General toxicity (F1)

Clinical signs:
effects observed, treatment-related
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified

Details on results (F1)

The size of litters was slightly, but significantly lower and were associated with small follicles.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
DMS significantly reduced female reproductive performance. The size of litters was slightly, but significantly lower and were associated with small follicles.