Potassium sodium tartrate

Endpoint summary

Description of key information

Tartaric acid can be considered as a non-sensitiser as determined by a GLP conducted 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. This result is supported by the prediction obtained using the validated QSAR MultiCase model (A33) for

the potassium sodium tartrate.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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other: Although reported GLP the information originated from a detailed review study that refers to an unpublished study.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

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

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 on result:

other: At 5.0 %: 1.0 At 10.0%: 0.9 At 25.0%: 1.5 LLNA EC3% - Not calculated

Interpretation of results:

not sensitising

Remarks:

Migrated information

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.

Reference 2

Endpoint:

skin sensitisation, other

Remarks:

Skin Sensitization, MultiCASE commercial model (A33)

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

In accordance with section 1 of REACH Annex XI, testing is not scientifically neccessary based on use of qualitative or quantitative structure - activity relationship (QSAR).

Guideline:

other: REACH guidance on QSARs R.6, May/July 2008

Principles of method if other than guideline:

Fragment-based statistical system used in the QSAR model.

Specific details on test material used for the study:

Data reported for the anhydrous salt.
SMILES: [Na]OC(=O)C(O)C(O)C(=O)OK

Parameter:

other: Data predicted from QSAR: data from GPMT or human experiences.

Value:

ca. -1

Remarks on result:

no indication of skin sensitisation based on QSAR/QSPR prediction

Endpoint: Skin

Value=-1 (negative)

Training set = 1033

LGO (10%) gave: Sensitivity = 69 -89 %; Specificity = 89 -94 %; Concordance = 82 -89 %; Applicability of domain = 0.58

Data from GPMT or human experiences.

Interpretation of results:

other: not sensitising

Conclusions:

Based on the prediction result indicated above the substance potassium tartrate (SMILES: [Na]OC(=O)C(O)C(O)C(=O)OK) has not to be classified for Sensitisation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)