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Toxicological information

Repeated dose toxicity: inhalation

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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.