Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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.