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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
chronic toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see remarks
Remarks:
1950 occupational exposure study of 15 individuals with long-term workplace exposure to tartaric acid dust. 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.
Justification for type of information:
similar substance
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
chronic toxicity: inhalation
Type of information:
other: publication
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see remarks
Remarks:
1950 occupational exposure study of 15 individuals with long-term workplace exposure to tartaric acid dust. 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.
Justification for type of information:
similar substance
Qualifier:
no guideline followed
Principles of method if other than guideline:
Occupational case study
GLP compliance:
no
Limit test:
no
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
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 was handled.
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
Dose / conc.:
4.5 mg/m³ air
Remarks:
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
Clinical signs:
no effects observed
Details on results:
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.
Dose descriptor:
LOAEC
Effect level:
ca. 4.5 mg/m³ air (analytical)
Based on:
test mat.
Sex:
female
Basis for effect level:
other:
Critical effects observed:
not specified
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.

Data source

Materials and methods

Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: crystalline

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Details on results:
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.

Effect levels

Dose descriptor:
LOAEC
Effect level:
ca. 4.5 mg/m³ air (analytical)
Based on:
test mat.
Sex:
female
Basis for effect level:
other:

Target system / organ toxicity

Critical effects observed:
not specified

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.