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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Principles of method if other than guideline:
Male and female sprague-Dawley rats were treated by gavage with 300, 600, or 1200 mg Tributyl phosphate/kg body weight which was given as single administration. The high dose level was set at the maximum tolerated dose. Bone marrow cells, arrested in metaphase and collected 12, 24 and 36 hours after treatment, were examined microscopically for structural chromosome aberrations.
GLP compliance:
yes
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.5 +-0.4%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
single administration
Frequency of treatment:
single administration
Post exposure period:
12, 24 or 36 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 300, 600, or 1200 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
15
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
bone marrow cells

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
1200 mg/kg was the maximum tolerated dose
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

the high dose was the maximum tolerated dose, mortality athe high dose level was 1/15 males and 4/15 females;
clinical signs of toxicity at 600 and 1200 mg/kg.
No increase of aberrant cells in bone marrow after 12, 24 of
36 hours.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

Male and female sprague-Dawley rats were treated by gavage with 300, 600, or 1200 mg Tributyl phosphate/kg body weight which was given as single administration. The high dose level was seet at the maximum tolerated dose. Bone marrow cells, arrwested in metaphase and collected 12, 24 and 36 hours after treatment, were examined microscopically for structural chromosome aberrations.

Under the conditions of the assay described in this report, tributyl phosphate, was negative in the acute cytogenetics assay using male and female sprague-Dawley rats.

Putman (1991)