Registration Dossier
Registration Dossier
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EC number: 201-766-0 | CAS number: 87-69-4
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity: oral
- 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:
- secondary source
- Title:
- Safety Assessment for Tartaric Acid, CAS Number 82-69-4
- Author:
- Tobacco Documents Library
- Year:
- 1 996
- Bibliographic source:
- Tobacco Documents Library
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test evaluated the ability of the compound at varying dose levels to modulate the host resistance to infectious challenge with LD10-30 dose of
Listeria monocytogenes bacteria and to alter the numbers of antibody plaque forming cells produced following immunization with sheep red blood cells. - GLP compliance:
- not specified
Test material
- Reference substance name:
- L- tartaric acid
- IUPAC Name:
- L- tartaric acid
- Test material form:
- not specified
- Details on test material:
- No details on test material identity are available.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- no data
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- for 5 days
- Frequency of treatment:
- no data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
3000
Basis:
other: mg/kg/day
- Remarks:
- Doses / Concentrations:
1500
Basis:
other: mg/kg/day
- Remarks:
- Doses / Concentrations:
750
Basis:
other: mg/kg/day
- Remarks:
- Doses / Concentrations:
0
Basis:
other: mg/kg/day
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
Examinations
- Observations and clinical examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Cell viabilities:
- The effect upon spleen, thymus, spleen ccllularity, and spleen cell viability were determined.
- Humoral immunity examinations:
- no data
- Specific cell-mediated immunity:
- no data
- Non-specific cell-mediated immunity:
- no data
- Other functional activity assays:
- no data
- Other examinations:
- no data
- Positive control:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Gross pathological findings:
- not specified
- Details on results:
- no data
Specific immunotoxic examinations
- Cell viabilities:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose-related decreases in PFC/10 viable spleen cells and PFC/spleen were observed.
- Humoral immunity examinations:
- not specified
- Specific cell-mediated immunity:
- not specified
- Non-specific cell-mediated immunity:
- not specified
- Other functional activity assays:
- not specified
- Other findings:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 3 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no effects upon host resistance
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Conclusions:
- L-tartaric acid had no effects upon host resistance at dose levels as high as 3000 mg/kg. Dose-related decreases in PFC/10viable spleen cells and PFC/spleen were observed at the highest dose, but these changes were not statistically significant. These finding suggest a lack of significant immunosuppressive potential attributable to L-tartaric acid at subtoxic dose levels.
- Executive summary:
The chemical did not produce immunosuppressive effects in rodents.
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