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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Immunotoxicity

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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:
1996
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

Constituent 1
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.

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.