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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: Data sharing dispute
Adequacy of study:
key study
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 met hodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

Reference
Reference Type:
publication
Title:
A study of experimental nephritis caused by the salts of tartaric acid.
Author:
PEARCE MR. and RINGER AI.
Year:
1913
Bibliographic source:
J. Med. Res. 29:57-64.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Subcutaneous exposition of in vivo animals to the substance to evaluate its acute toxicity.
GLP compliance:
not specified
Test type:
other: no data

Test material

Constituent 1
Reference substance name:
(-)-tartaric acid
EC Number:
205-695-6
EC Name:
(-)-tartaric acid
Cas Number:
147-71-7
Molecular formula:
C4H6O6
IUPAC Name:
tartaric acid

Test animals

Species:
dog
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
phlorhizinized dog

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
one dose for one dog only
Doses:
10 g
No. of animals per sex per dose:
no data
Control animals:
yes
Details on study design:
The control dog was phlorhizinized and no tartrate was given.
Statistics:
no data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
other: lethal dose
Effect level:
ca. 10 other: g
Based on:
test mat.
Remarks on result:
other: Death occured thirty-six hours later
Mortality:
The animal lived for thirty-six hours
Clinical signs:
no data
Body weight:
no data
Gross pathology:
Kidney
Same necrotic lesion of tubules but not so severe, a few hyaline casts in collecting tubules; no glome
rular lesion. Fatty changes are most marked in the thick ascending limbs of the medullary loops, th
ough occasionally also in convoluted tubules.
Liver
Some coarse fatty change and extensive fine vacuolization of liver cells.
Other findings:
Autopsy showed a marked edema of perirenal tissues.

Any other information on results incl. tables

The urine for the last twenty-four hours amounted to only a few cubic centimeters, and contained a

small amount of albumin. Observations in control animal Urine: no albumin, usual picture of phlorhizin

glucosuria Kidney: some vacuolization of cells of loops of Henle. Cells of convoluted tubules are more

granular than usual, but there is no necrosis, no casts and no edema. The glomeruli are normal. Liver:

many cells show a fatty transformation with numerous fine fat droplets; other cells show no eosin-staining

protoplasm, the nucleus persisting in a cell with fine colorless network. There are a few cells full of fat.

Pancreas: no changes.

Applicant's summary and conclusion

Interpretation of results:
other: not classified Migrated information Criteria used for interpretation of results: EU
Conclusions:
10 g of D-tartaric acid were given subcutaneously to a phlorhizinized dog which died thirty-six hours later the treatment.
Executive summary:

10 g of D-tartaric acid were given subcutaneously to a phlorhizinized dog which died thirty-six hours later the treatment.