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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Vehicle:
other: mixture ethanol/water (50/50)
Parameter:
SI
Value:
0
Test group / Remarks:
Reading: 1st reading. . Hours after challenge: 28.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
Parameter:
SI
Value:
1.1
Test group / Remarks:
dose 2.5% and 5%
Parameter:
SI
Value:
1.59
Test group / Remarks:
dose 10%

No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.

Conceming the lymphoproliferative response, the incorporation of tritiated methyl thymidine in the treated groups was similar to that ofthe vehicle control group.

disintegrations per minute (DPM)P
er Node:  Negative control: 43.43  2.5%: 47.90 5%: 47.88 10%: 69.20  

Per group:  Negative control: 347.47  2.5%: 383.17 5%: 383.04 10%: 553.59

Interpretation of results:
GHS criteria not met
Conclusions:
According to EEC (European Economie Community) and CLP classification the tested substance Acid Orange 7 is not a skin sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of Acid Orange 7 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The results of the available tests abotu the evaluation of dermal effects on human showed no sensitizing effects.

Therefore the tested substance should not be considered to be a sensitizer.

Justification for selection of skin sensitisation endpoint:

The study was performed on a tested substance with a higher content of active ingredient.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Acid Orange 7 should not be considered to be a sensitizer according to Regulation CLP (CE n. 1272/2008).