Potassium hydrogen tartrate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

repeated dose toxicity: inhalation, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1950

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: 1950 occupational exposure study of 15 individuals with long-term workplace exposure to tartaric acid dust.

Remarks:

Does not allow interpretation following any inhalatory toxicity test guideline, but offers insight into effects and relevance of long-term exposure to tartaric acid dust.

Data source

Reference

Reference Type:

publication

Title:

Erosion of Teeth due to Tartaric Acid Dust

Author:

Elsbury, W.B., Browne, R.C., and Boyes, J.

Year:

1950

Bibliographic source:

Brit. J. Industr. Med., 1954, 8, 179.

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

526-83-0

Cas Number:

526-83-0

IUPAC Name:

526-83-0

Specific details on test material used for the study:

The material to which the subjects were occupationally exposed is referred to in the study as "tartaric acid dust" in a tin making factory. This dust was quantitated gravimetrically and extimated to be at an airbourne concentration of 15 mg/m3. Percentual coposition of this powder was reported to be: 7.7% free tartaric acid; 22.5% combined tartaric acid; 16.5% sodium bicarbonate; 37.2% magnesium sulphate; 14.3% sucrose and 9.5% insoluble residue. Thereby the approximate amount of free and combined (tartrates) tartaric acid is estimated to account for 30.2% of the dust. Thereby the typical dust concentration of free and combined tartrates to which the workers were exposed results in approximately: 4.5 mg/m3

Test animals

Species:

other: Occupational exposure - human

Sex:

female

Details on test animals or test system and environmental conditions:

As a result of their occupation in a tin making company the effect of exposure to a reportedly "very dusty atmosphere" containing approximately 4.5 mg/m3 of free and combined tartaric acid was studied. The study describes exposures of 15 young individuals (females) for periods between 6 and 22 months, with weekly exposure times of 29 - 30 h to dust in mixing rooms were the substance

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

The occupational report describes effects of occupational exposure of 15 "girls" employed in a tin-making factory. Exposure takes place to dust in operations involving scooping powders out of drums, weighing, emptying them down chutes into hoppers and mixing . This generates a disty atmosphere to which the subjects are exposed unprotected for 29 - 30 h/ week for periods of 6 months to 22 months as reported in the study. Report indicates that although masks are supplied, these are not worn.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Composition of powder partially reported but analytical technique not described.

Duration of treatment / exposure:

> 180 days

Frequency of treatment:

Workplace exposure. Daily, 5 days/week.

Doses / concentrations

Dose / conc.:

4.5 mg/m³ air

Remarks:

Approx 4.5 mg/m3 free and combined tartrates

No. of animals per sex per dose:

15 young female employees exposed to approximately 4.5 mg/m3 free tartaric acid and tartrates.

Control animals:

other: 16 comparable individuals of same age and financial status working in another section of the tin making plant with no dust exposure

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Description (incidence and severity):

The report focuses on effects of the tartaric acid (and combined tartrates) which are inhaled and presumably retained in the mouth and upper respiratory tract. This leads to severely acidic saliva which on long term exposure leads to teeth erosion with progressive disappearance of the enamel and exposure of the dentine, leading to the eventual loss of the pieces. No other clinical signs of intoxication, respiratory distress or other lesions are reported.

Mortality:

no mortality observed

Description (incidence):

The report focuses on effects of the tartaric acid (and combined tartrates) which are inhaled and presumably retained in the mouth and upper respiratory tract. This leads to severely acidic saliva which on long term exposure leads to teeth erosion with progressive disappearance of the enamel and exposure of the dentine, leading to the eventual loss of the pieces. No other clinical signs of intoxication, respiratory distress or other lesions are reported.

Body weight and weight changes:

no effects observed

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:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Effect levels

Dose descriptor:

LOAEC

Effect level:

ca. 4.5 mg/m³ air

Based on:

test mat.

Sex:

female

Basis for effect level:

other: Severely acidic saliva as a consequence of occupational inhalation of particles

Applicant's summary and conclusion

Conclusions:

Long term worker exposure to free tartaric acid and combined tartaric acid dust in conditions of high dustiness (ca. 4.5 mg/m3) for periods of 30 h/week for more than 6 months result in teeth erosion and progressive loss of dental pieces, but other clinical signs, morbidity or lethality are reported in a case study involving 15 youn females exposed in a tin-making company. Thereby the long term LD50 can be assumed to be well above 4.5 mg/m3.

Executive summary:

The report focuses on effects of the tartaric acid (and combined tartrates) which are inhaled and presumably retained in the mouth and upper respiratory tract. This leads to severely acidic saliva which on long term exposure leads to teeth erosion with progressive

disappearance of the enamel and exposure of the dentine, leading to the eventual loss of the pieces.