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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
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:
The effect of tartrates on the human kidney
Author:
Post
Year:
1914
Bibliographic source:
Journal of the American Medical Association. 1914; 62,(8): 592-593

Materials and methods

Type of study / information:
Observations were accordingly made on several patients in the service of Dr. Frank Billings and occupying the Sprague Institute beds in the Presbyterian Hospital. Potassium and sodium tartrate was given by mouth to ordinarily well-fed adults. The dose was from 1 to 6 drams, the average dose authorized by the U. S. Pharmacopeia being 2 drams. Each voiding of urine was put into separate clean sterile bottles and placed at once in an ice-box. The test for albumin was by the use of acetic acid and potassium ferrocyanid. The hydrogen ion concentration was determined, in some of the cases, by means of indicators. The observation regards the effects of tartrate on the kidney.
Endpoint addressed:
repeated dose toxicity: oral
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
No details on test material identity are available.

Method

Ethical approval:
not applicable
Details on study design:
no data
Exposure assessment:
not specified
Details on exposure:
Potassium and sodium tartrate was given by mouth to ordinarily well-fed adults. The dose was from 1 to 6 drams.

Results and discussion

Results:
Overall, after urine examination are detected:
- no albumin;
- faint trace nucleo-albumin;
- occasional hyaline and hyalogranular cast;
- occasional leukocyte;
- sediment same plus numerous spermatozoa ;
- reaction same faint trace nucleoalbumin;
- sediment;
- urate occasional cylindroid.

Any other information on results incl. tables

 Endpoint  Effect level  Based on  Sex  Observation  
urine examination  2-6 drams  test mat. man   CASE 1 Moderately advanced arteriosclerosis. Urine examinations in different time: - no albumin - faint trace nucleo-albumin; occasional hyaline and hyalogranular cast, occasional leukocyte. Reaction neutral to paranitrophenol - faint trace serumalbumin; sediment same. Reaction neutral to methyl red - no albumin. Few casts. Reaction neutral to rosolie acid - no albumin. Sediment same. Neutral to rosolie acid - faint trace nucleoalbumin. Sediment same plus numerous spermatozoa ;reaction same - distinct trace serum albumin; occasional hyaline cast; neutral to rosolie acid - seven specimens ; two showed faint trace nucleo-albumin, others no albumin. All neutral to rosolie acid; sediments same as above - no albumin; sediment same; neutral to methyl red  

urine examination

 
 2 drams   test mat.  man CASE 2 Acute bronchitis - faint trace nucleoalbumin. Sediment; urate occasional cylindroid. - faint trace nucleoalbumin; numerous cylindroids - No albumin. Sediment, numerous cylindroids. 
 urine examination  2 drams  test mat.  Woman CASE 3 Hysteric hemiplegia, right-sided pyelitis (interval). - faint trace nucleoalbumin sediment; moderate number of leukocytes; bacilli, neutral to rosolie acid - faint trace nucleoalbumin; sediment same; neutral to paranitrophenol - faint trace nucleo-albumin; sediment same; neutral to rosolie acid   
 urine examination  2 -3 drams  test mat.  man  CASE 4 Acute bronchitis. - no albumin; few mucus threads; occasional leukocyte - no albumin; sediment same as above - faint trace albumin; numerous cylindroids; no casts - no albumin; sediment same as above  
 urine examination  3 drams  test mat.  male  CASE 5 Lumbago; tonsillectomy. - acid to litmus; distinct trace albumin; few hyalogranular casts - neutral to rosolie acid; distinct trace albumin; ruther numerous leukocytes; occasional cast - neutral to rosolie acid; no albumin; sediment same - neutral to methyl red; faint trace nucleo-albumin  
urine examination   3 drams  test mat.  male CASE 6 Acute tonsillitis. - neutral to paranitro phenol; faint trace albumin; mates and calcium oxalate crystals - practically same findings except no crystals - faint trace albumin; urates - neutral to paranitrophenol; faint trace albumin; urates - neutral to rosolie acid; no albumin; occasional cylindroid and hyalogranular cast - neutral to methyl red; faint trace nucleo-albumin and serum albumin - neutral to paranitrophenol; no albumin   
urine examination   2 drams  test mat  male  CASE 7 Osteo-arthritis - urinalysis showed no albumin or casts - prolonged attack of diarrhea with severe abdominal cramps - the legs and scrotum were markedly edematous and there was free fluid in the abdomen and fluid in the right chest - urinalysis showed a large amount of albumin and many hyaline and granular and epithelial casts  

Applicant's summary and conclusion

Conclusions:
These cases study give no evidence indicating that potassium sodium tartrate in ordinary doses given by mouth in the human subject will cause albuminuria or cylindruria. There is no evidence to show that tartrates aggravate an existing nephritis. The acidity of the urine, indicated by the hydrogen ion concentration, was as a rule less after the administration of tartrates.
Executive summary:

These cases study give no evidence indicating that potassium sodium tartrate in ordinary doses given by mouth in the human subject will cause albuminuria or cylindruria. There is no evidence to show that tartrates aggravate an existing nephritis. The acidity of the urine, indicated by the hydrogen ion concentration, was as a rule less after the administration of tartrates.