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Toxicological information

Repeated dose toxicity: oral

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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:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
purity 99.7 %

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).