Registration Dossier
Registration Dossier
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EC number: 203-874-3 | CAS number: 111-48-8
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: sub-chronic gavage study comparable to OECD TG408 with data relating to fertility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Principles of method if other than guideline:
- Effects on reproductive organs in a 90 d gavage study comparable to OECD Guide-line 408.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Thiodiglycol
- EC Number:
- 203-874-3
- EC Name:
- Thiodiglycol
- Cas Number:
- 111-48-8
- Molecular formula:
- C4H10O2S
- IUPAC Name:
- 2-[(2-hydroxyethyl)sulfanyl]ethan-1-ol
- Details on test material:
- Samples analysed by gas chromatography before, during, and after the study; purity >= 95%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Exposure period: 91-92 days
- Frequency of treatment:
- once daily, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 500, 5000 mg/kg bw/day
Basis:
- Control animals:
- yes, sham-exposed
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: effects on reproductive organs in a 90-day gavage study
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 5 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: effects on reproductive organs in a 90-day gavage study
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Due
to the decreased body weight the mean relative organ weights
of testes were significantly higher in males of the high dose group;
however, no significant effects were seen with the mean absolute testes
weights (no toxicological relevance, no changes in histopathology). No
effect on other organ weights mentioned under test condition.
Pathology/histopathology: no changes related to the test substance
in any organ mentioned under test condition.
Applicant's summary and conclusion
- Conclusions:
- In the subchronic gavage study in rats no effects on reproductive organs were found at dose levels up to 5000 mg/kg bw/day.
- Executive summary:
Comparable to OECD guideline 408.
Details of this study are presented in Section 7.5.1.
In the subchronic gavage study in rats no effects on reproductive organs were found at dose levels up to 5000 mg/kg bw/day.
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