Registration Dossier
Registration Dossier
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EC number: 227-006-8 | CAS number: 5593-70-4
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- 14-day study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- May 25, 1949
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study report does not give sufficient experimental details
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 949
- Report date:
- 1949
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated sublethal doses of test substance were administered orally. Total of 10 doses (five times a week for 2 weeks) were administered in six rats.
- GLP compliance:
- no
Test material
- Reference substance name:
- Titanium tetrabutanolate
- EC Number:
- 227-006-8
- EC Name:
- Titanium tetrabutanolate
- Cas Number:
- 5593-70-4
- Molecular formula:
- C16H36O4Ti
- IUPAC Name:
- titanium(4+) tetrakis(butan-1-olate)
- Details on test material:
- - Name of test material (as cited in study report): tetrabutyl titanate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animals were dosed 5 times a week for 2 weeks, receiving in total 10 doses of 1500mg/kg each dose.
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 5 times a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1500mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 6 animals
- Details on study design:
- Six rats were given test substance 1500mg/kg five times a week for two weeks.
Examinations
- Observations and examinations performed and frequency:
- Clinical signs and body weights of the animals were measured but frequency not reported. After 10th dose animals were killed, necropsied and tissues examined macroscopically.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- no mortalities observed during the test
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- no mortalities observed during the test
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slight loss of weight after first treatment but a normal gain thereafter
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 5 rats, no pathology; 1 rat, Spleen - numerous foci of blood formation; Kidney - albumin
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: only 10 doses were administered
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A repeated dose toxicity of titanium tetrabutanolate was determined administering ten oral doses to rats during two-weeks period. Repeated sublethal doses of 1500mg/kg caused a slight loss of weight after the first treatment but a normal gain thereafter. Therefore, the NOAEL of 1500 mg/kg bw/day is considered.
- Executive summary:
This study was regarded not assignable since the study report does not give sufficient experimental details.
The result of this study is used as a weight of evidence in hazard assessment.
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