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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation, other
Remarks:
other: prediction from hazard class
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Automatic calculation with MeCLas tool
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2014

Materials and methods

Principles of method if other than guideline:
Skin sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.
GLP compliance:
no
Remarks:
other quality assurance was applied

Test material

Constituent 1
Reference substance name:
Matte leaching residue
IUPAC Name:
Matte leaching residue
Constituent 2
Reference substance name:
Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
EC Number:
310-050-8
EC Name:
Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
Cas Number:
102110-49-6
IUPAC Name:
Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.
Details on test material:
No further details

Results and discussion

In vitro / in chemico

Results
Remarks on result:
not measured/tested

In vivo (non-LLNA)

Results
Remarks on result:
not measured/tested

In vivo (LLNA)

Results
Remarks on result:
not measured/tested

Any other information on results incl. tables

 According to MeClas the substance is classified as Skin sensitiser Cat 1 - H317.

Applicant's summary and conclusion

Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as Skin sensitiser Cat 1 - H317.
Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.