Registration Dossier
Registration Dossier
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EC number: 204-800-2 | CAS number: 126-73-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2650 (90-Day Oral Toxicity in Rodents)
- Principles of method if other than guideline:
- Tributyl phosphate was administered in the diet to CD-1 mice (15/sex/group at study initiation) at concentrations of 0, 500, 2000, or 8000 ppm for ninety days. Control animals received standard laboratory diet.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tributyl phosphate
- EC Number:
- 204-800-2
- EC Name:
- Tributyl phosphate
- Cas Number:
- 126-73-8
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- tributyl phosphate
- Details on test material:
- purity 99.7 %
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 3 month
- Frequency of treatment:
- daily (feeding study)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 2000 and 8000 mg/kg diet (75, 300 and 1200 mg/kg bw/day)
Basis:
- No. of animals per sex per dose:
- 15/sex/group
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 500 ppm
- Sex:
- male/female
- Basis for effect level:
- other: 500 ppm = 75 mg/kg bw
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All animals survived, in the highest concentration body
weight loss and reduced body weight gain with reduced food
consumption and reduced fecal volume, elevation of absolute
and relative liver weights with hepatocyte hypertrophy,
slight to moderate epithelial hyperplasia of the urinary
bladder, some slight hematological alterations and some
effects on clinical chemistry parameters of liver function.
In the middle concentration slight decrease of weight gains,
elevated terminal ALT and AST in females and moderately
elevated liver weights in both sexes, slight hepatocyte
hypertrophy and minimal or slight epithelial hyperplasia of
the urinary bladder.
No effects of test material administration was evident in
animals receiving the lowest concentration (500 ppm).
NOEL: 75 mg/kg bw/day
Applicant's summary and conclusion
- Executive summary:
Tributyl phosphate was administered in the diet to CD-1 mice (15/sex/group at study initiation) at concentrations of 0, 500, 2000, or 8000 ppm for ninety days. Control animals received standard laboratory diet. All animals survived until their sheduled termination dates. No effects of test material administration were evident in animals receiving the lowest concentration (500 ppm = 75 mg/kg bw).
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