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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Toxicology of the Citric Acid Esters: Tributyl Citrate, Acetyl Tributyl Citrate, Triethyl Citrate and Acetyl Triethyl Citrate
Author:
Finkelstein M & Gold H
Year:
1959
Bibliographic source:
Toxicol Applied Pharmacology 1, p. 283 - 298

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
other: no data
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
Single dosing with 10 - 30 mL/kg
No. of animals per sex per dose:
5 rats
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 30 mL/kg bw
Based on:
not specified

Any other information on results incl. tables

Shortly after the administration, the oily material began to leak from the rectum. The animals became somewhat sluggish, but recovered promptly, and in the following period of 3 weeks of observation showed no signs suggesting systemic toxicity. In view of the fact that the largest doses corresponded to approximately 2 liters of the material for an average human, it was clear that tributyl citrate by oral administration in rats was free of toxicity in terms of the general appearance of the animal. It did not seem profitable to extend this phase of the study of the acute effects.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 (rat)> 30 mL/kg bw
Executive summary:

According to "Toxicology of the Citric Acid Esters: Tributyl Citrate, Acetyl Tributyl Citrate, Triethyl Citrate and Acetyl Triethyl Citrate" (Finkelstein M & Gold H, 1959) the acute oral toxicity of tributyl citrate was studied in 5 rats in the range of doses from 10 to 30 mL/kg administered by stomach tube.

Shortly after the administration, the oily material began to leak from the rectum. The animals became somewhat sluggish, but recovered promptly, and in the following period of 3 weeks of observation showed no signs suggesting systemic toxicity. In view of the fact that the largest doses corresponded to approximately 2 liters of the material for an average human (LD50 > 30 mL/kg), it was clear that tributyl citrate by oral administration in rats was free of toxicity in terms of the general appearance of the animal. It did not seem profitable to extend this phase of the study of the acute effects.