Registration Dossier
Registration Dossier
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EC number: 401-100-0 | CAS number: 109037-78-7 TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: not limit test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study by GLP lab
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- EC Number:
- 401-100-0
- EC Name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- Cas Number:
- 109037-78-7
- Molecular formula:
- C24 H46 O10 P2 Ti2 (typical - see 'Remarks' below.
- IUPAC Name:
- butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
Constituent 1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: none
- Details on oral exposure:
- Method of administration: Oral Gavage
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosage regime: 7 days/week.
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 160 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 160 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 8 animals (low dose - 1 male, middle dose - 1, male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 8 animals (low dose - 1 male, middle dose - 1, male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (nominal)
- Basis for effect level:
- other: Original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 0 mg/kg bw/day (nominal)
- Basis for effect level:
- other: Original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
8 animals (low dose - 1 male, middle dose - 1 male, 2 female, high dose - 1 male, 3 female) were found dead or killed in extremis.
Body weight gain was lowered for males (weeks 1 and 2) and females (weeks 1 and 4) in the high dose group.
Applicant's summary and conclusion
- Conclusions:
- Not classified.
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