Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: not sensitising (modified OECD 429; GLP)

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:
The two pseudobrookite type pigments are structurally very similar with similar composition. Both show a very low solubility in different artificial and aqueous media. Since the target substance and the source substance release the same (eco-)toxicological relevant units under environmental/physiological relevant conditions, the biological target will be the same for both substances.
Based on the above explanation an analogue approach for read-across of the endpoint “Skin sensitisation ” from the structural analogue to the target substance is considered justified (see also attached document under in section 13 of this technical dossier).
Reason / purpose for cross-reference:
read-across source
Key result
Parameter:
SI
Value:
1.066
Test group / Remarks:
10% (w/w) test item
Remarks on result:
other: 10 % (w/w) test item; lymph node cell count
Key result
Parameter:
SI
Value:
1.006
Test group / Remarks:
10 % (w/w) test item
Remarks on result:
other: 10 % (w/w) test item; ear weight
Key result
Parameter:
SI
Value:
0.842
Test group / Remarks:
25 % (w/w) test item
Remarks on result:
other: 25 % (w/w) test item; lymph node cell count
Key result
Parameter:
SI
Value:
1.067
Test group / Remarks:
25 % (w/w) test item
Remarks on result:
other: 25 % (w/w) test item; ear weight
Key result
Parameter:
SI
Value:
1.258
Test group / Remarks:
50 % (w/w) test item
Remarks on result:
other: 50 % (w/w) test item; lymph node cell count
Key result
Parameter:
SI
Value:
1.055
Test group / Remarks:
50 % (w/w) test item
Remarks on result:
other: 50 % (w/w) test item; ear weight
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

One reliable animal study described in Haferkorn (2017) (modified OECD 429; method according to Ehlings et al. 2005; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

The substance does not possess a skin sensitisation potential and does not require classification as skin sensitiser according to Regulation (EC) No 1272/2008 and subsequent adaptations.