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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
repeated dose toxicity: other route
Remarks:
other: 1 week
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been assessed for the use in a category approach. According to the methodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

Reference
Reference Type:
publication
Title:
TARTRATE NEPHRITIS, WITH ESPECIAL REFERENCE TO SOME OF THE CONDITIONS UNDER WHICH IT MAY BE PRODUCED.
Author:
Underhill et al.
Year:
1913
Bibliographic source:
J Exp Med. 1913;18(4):322-46

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data

Test material

Constituent 1
Reference substance name:
sodium tartarte
IUPAC Name:
sodium tartarte
Test material form:
not specified
Details on test material:
No details on test material identity are available.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Male Rabbit, Weighing 2,200 Grams
Female Rabbit, Weighing 2,200 Grams

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
water
Details on exposure:
Subcutaneous injection of tartaric acid neutralized with sodium carbonate in water without phlorizin administration
Duration of treatment / exposure:
1 week
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
RABBIT E: subcutaneous injection of 3 gm tartaric acid, neutralized with sodium carbonate, in 40 c.c. water.
RABBIT F: subcutaneous injection of 3 gm tartaric acid neutralized with sodium carbonate.
No. of animals per sex per dose:
1 male and 1 female
Control animals:
not specified
Details on study design:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
one animal found dead.
Mortality:
mortality observed, treatment-related
Description (incidence):
one animal found dead.
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
determination of creatinin and total nitrogen
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Kidneys were pale and soft.
Histopathological findings: neoplastic:
not specified
Details on results:
RABBIT E - Histological Examination. Kidney. Necrosis of the convoluted tubules is almost universal, and the necrotic epithelium is generally disintegrated. The collecting tubules show little change and there are many casts. The glomerules and interstitial tissue seem unaffected. Determination of creatinin and total nitrogen.


RABBIT F - Histological Examination. Kidney.Necrosis of the convoluted tubules is almost universal, and the necrotic epithelium is generally disintegrated. The collecting tubules show little change and there are many casts. The glomerules and interstitial tissue seem unaffected.In the pelvis is a mass of coagulated protein, apparently from highly albuminous urine. Determination of creatinin and total nitrogen.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
ca. 3 other: gm
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Found dead.
Remarks on result:
not determinable
Remarks:
no NOAEL identified
Dose descriptor:
NOAEL
Effect level:
ca. 3 other: gm
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Animal in light coma. Kidneys were pale and soft.
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
Significant toxic effect occurred in rabbit after daily subcutaneous injection of tartaric acid, neutralized with sodium carbonate. The kidney is main organ involved.
Executive summary:

The subcutaneous administration of sodium tartrate to rabbit caused a pronounced disintegrative action upon the epithelium of the kidney.