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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Endpoint-specific justification for readacross
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
other: Bibliographic source
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although reported GLP the information originated from a detailed review study that refers to an unpublished study. Thereby full details are nonot available for examination.
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Report states CAS for L-tartaric acid (natural isomer)
Species:
mouse
Strain:
CBA
Sex:
female
Vehicle:
dimethylformamide
Concentration:
25 microliters of test material. According to OECD Guideline.

Concentrations used: 5.0, 10.0 and 25% tartaric acid
No. of animals per dose:
According to OECD Guideline. No further detail reported in review.
Parameter:
SI
Remarks:
At 5.0%
Value:
ca. 1
Parameter:
SI
Remarks:
At 10.0%
Value:
ca. 0.9
Parameter:
SI
Remarks:
At 25.0%
Value:
ca. 1.5
Parameter:
EC3
Remarks on result:
other: not calculated
Interpretation of results:
other: not sensitising
Conclusions:
Tartaric acid can be considered as a non-sentitiser as determined by OECD test guideloin 429. This information is fully relevant towards read across to potassium sodium tartrate as the salt dissociates in solution into the tartrate group, yielding an identical active organic group in solution.
Executive summary:

Tartaric acid can be considered as a non-sentitiser as determined by OECD test guideline 429. This information is fully relevant towards read across to potassium sodium tartrate as the salt dissociates in solution into the tartrate group, yielding an identical active organic group in solution.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks:
At 5.0%
Value:
ca. 1
Parameter:
SI
Remarks:
At 10.0%
Value:
ca. 0.9
Parameter:
SI
Remarks:
At 25.0%
Value:
ca. 1.5
Parameter:
EC3
Remarks on result:
other: not calculated

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Read-across from supporting substance (structural analogue or surrogate). In this case the analogue substance selected was Tartaric acid. Tartaric acid can be considered as a non-sentitiser as determined by OECD test guideloin 429. This information is fully relevant towards read across to potassium sodium tartrate as the salt dissociates in solution into the tartrate group, yielding an identical active organic group in solution.
Executive summary:

Tartaric acid can be considered as a non-sentitiser as determined by OECD test guideline 429. This information is fully relevant towards read across to potassium sodium tartrate as the salt dissociates in solution into the tartrate group, yielding an identical active organic group in solution.