Antimony nickel titanium rutile

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

ANALOGUE APPROACH JUSTIFICATION
The analogy in physico-chemical properties as well as the behaviour in the bioaccessability studies indicate that both test compounds are of low bioavailability after dermal exposure. The bioaccessability study as well as the additional bioelution study on Sicotan Yellow K 1010 show that the release of Ni is negligible and well below the threshold of 0.5 g/cm2/week (CLP, Annex I, Note U, point 7). Structure and composition of the substances is virtually identical in regard to side components and impurities. Both substances do not show an irritation potential when applied onto skin (or into eyes).
Thus, based on the above mentioned similarities the read across for the endpoint skin sensitization from Sicotan Yellow K 2011 to Sicotan Yellow K 1010 is considered to be acceptable.

The full read across justification is attached in chapter 13 of this IU6 dossier.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

10%

Key result

Parameter:

SI

Value:

1.69

Test group / Remarks:

25%

Key result

Parameter:

SI

Value:

1.2

Test group / Remarks:

50%

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available