Registration Dossier
Registration Dossier
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EC number: 217-699-5 | CAS number: 1934-21-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- 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:
- propylene glycol
- Concentration:
- 1; 2,5 and 5%
- No. of animals per dose:
- 4 females per group
- Positive control substance(s):
- not specified
- Positive control results:
- No data
- Parameter:
- SI
- Value:
- ca. 1.48
- Test group / Remarks:
- 1% : 1,48
- Parameter:
- SI
- Value:
- 1.46
- Test group / Remarks:
- 2,5%: 1.46
- Parameter:
- SI
- Value:
- 2.16
- Test group / Remarks:
- 5 %: 2.16
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Per group: Vehicle: 309.20 1%: 458.7 2,5%: 450.02 5%: 667.02 Per node: Vehicle: 38.65 1%: 57.34 2,5%: 56.25 5%: 83.38
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EEC (European Economie Community) and CLP classification the tested substance Acid yellow 23 is not a skin sensitizer.
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of Acid Yellow 23 when administered to the skin of CBA mice following OECD 429, murine local lymph assay.
Based on the results, the tested item should not be considered as skin sensitizer under defined experimental conditions in the two vehicles tested.
Reference
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Concerning the lymphoproliferative response, no positive lymphoproliferative response (SI > 3) and no dose-response relationship were noted.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for selection of skin sensitisation endpoint:
Study well reported, acceptbale for the assessment.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The results of the available tests about the evaluation of dermal effects on human showed no sensitizing effects.
Therefore the Acid Yellow 23 should not be considered to be a sensitizer.
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