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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
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study: meets scientific standards with acceptable restrictions (limited number of animals in study, partly limited documentation)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1959
Reference Type:
study report
Title:
Unnamed
Year:
1959

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: Study from 1959 (no guidelines available at the time the study was performed)
Deviations:
not applicable
GLP compliance:
no
Remarks:
Study from 1959 (GLP was not compulsory at the time the study was performed)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Name of test material (as cited in study report): Acetyl tributyl citrate (CAS RN 77-90-7)
Analytical purity: not stated

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 (ca. 10.5 - 31.5 g)
No. of animals per sex per dose:
Dosed was a group of 5 animals (no further details reported)
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 21 d
Frequency of observations and weighing: not reported
Necropsy of survivors performed: not reported
Other examinations performed: body weight,organ weights, histopathology
Statistics:
Not further specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 31 500 mg/kg bw
Remarks on result:
other: Endpoint was estimated, as there were no signs of toxicity to be found at test doses
Mortality:
No deaths occured at any dose level throughout the study.
Clinical signs:
Shortly after administration, the material began to leak from the rectum. Transient sluggishness was reported.
Body weight:
Not reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category V
Remarks:
Migrated information
Conclusions:
In this older study with Wistar rats the LD50 was estimated with > 30 mL/kg (ca. 31500 mg/kg)
Executive summary:
In this older study Wistar rats were dosed once with 10 - 30 mL/kg (ca. 10500 - 31500 mg/kg) via gavage. All animals were observed for signs of toxicity for 21 d following dosing. The dosing caused no deaths and the estimated LD50 was given with > 30 mL/kg (ca. 31500 mg/kg).