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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
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

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.

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.

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.