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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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 spinel 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 iron, zinc and chromium under environmental/physiological relevant conditions, the biological target will be the same for both substances. The target substance also releases titanium ions at a minute amount, which are not known to show signs of systemic toxicity (OECD SIDS, 2013). The source substance liberates small amounts of the toxic unit nickel, without showing any signs of systemic or local toxicity in various studies (acute oral and inhalation, skin/eye irritation, sensitisation).
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
Positive control results:
The positive control group caused the expected increases in lymph node cell count and lymph node weight (statistically significant at p ≤ 0.01). The values for the stimulation index of lymph node cell count and lymph node weight were 1.715 and 1.544, respectively. Therefore, the study can be regarded as valid.
Key result
Parameter:
SI
Value:
1.051
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:
1.018
Test group / Remarks:
10 % (w/w) test item
Remarks on result:
other: 10% (w/w) test item, lymph node weight
Key result
Parameter:
SI
Value:
0.951
Test group / Remarks:
10 % (w/w) test item
Remarks on result:
other: 10 % (w/w) test item; ear weight
Key result
Parameter:
SI
Value:
1.017
Test group / Remarks:
10 % (w/w) test item
Remarks on result:
other: 10% (w/w) test item; ear thickness
Key result
Parameter:
SI
Value:
0.917
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:
0.965
Test group / Remarks:
25% (w/w) test item
Remarks on result:
other: 25% (w/w) test item, lymph node weight
Key result
Parameter:
SI
Value:
0.975
Test group / Remarks:
25 % (w/w) test item
Remarks on result:
other: 25 % (w/w) test item; ear weight
Key result
Parameter:
SI
Value:
1.06
Test group / Remarks:
25% (w/w) test item
Remarks on result:
other: 25% (w/w) test item; ear thickness
Key result
Parameter:
SI
Value:
0.907
Test group / Remarks:
50 % (w/w) test item; ear weight
Remarks on result:
other: 50 % (w/w) test item; lymph node cell count
Key result
Parameter:
SI
Value:
1.053
Test group / Remarks:
50% (w/w) test item
Remarks on result:
other: 50% (w/w) test item; lymph node weight
Key result
Parameter:
SI
Value:
0.901
Test group / Remarks:
50 % (w/w) test item
Remarks on result:
other: 50 % (w/w) test item; ear weight
Key result
Parameter:
SI
Value:
1.043
Test group / Remarks:
50% (w/w) test item
Remarks on result:
other: 50% (w/w) test item; ear thickness

In the main study treatment with the test item at concentrations of 10%, 25% or 50% did not reveal statistical significantly increased values for lymph node cell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Hence, the test item is classified as not sensitising.

The threshold level for the ear weight of 1.1 was not exceeded and no increase of ear thickness was observed, i.e. no irritating properties were noted.

No signs of local or systemic intolerance were recorded. The animal body weight was not affected by the treatment.

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 (2013) (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.