Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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other: Although reported GLP the information originated from a detailed review study that refers to an unpublished study.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

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Report states CAS for L-tartaric acid (natural isomer)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

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.

Results and discussion

In vivo (LLNA)

Results
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

Applicant's summary and conclusion

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.