Registration Dossier
Registration Dossier
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EC number: 221-621-5 | CAS number: 3164-34-9
Skin sensitisation
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- other: Although reported GLP the information originated from a detailed review study that refers to an unpublished study.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:
- 2 010
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- (+)-tartaric acid
- EC Number:
- 201-766-0
- EC Name:
- (+)-tartaric acid
- Cas Number:
- 87-69-4
- Molecular formula:
- C4H6O6
- IUPAC Name:
- (2R,3R)-2,3-dihydroxybutanedioic acid
- Details on test material:
- Report states CAS for L-tartaric acid (natural isomer)
Constituent 1
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.
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