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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
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: calculation tool MeClas (www.meclas.eu) is used
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:
2013

Materials and methods

Principles of method if other than guideline:
The C&L for toxic to specific target organ after repeated dose application of Matte, precious metal 1 was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Matte, precious metal
EC Number:
308-506-6
EC Name:
Matte, precious metal
Cas Number:
98072-52-7
IUPAC Name:
diiron(3+) copper(2+) lambda2-cobalt(2+) lambda2-iron(2+) lambda2-lead(2+) disilver(1+) (trinickel-1-ylidene)-1lambda4-disulfene tellurium octasulfanediide
Test material form:
other: solid
Details on test material:
see "confidential details on test material"

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

"Matte, precious metal" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Matte, precious metal" may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of "Matte, precious metal".

MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.

 

From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.

 

The following data were used as input of MeClas:

 

1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.

 

2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.

Applicant's summary and conclusion

Conclusions:
Classification driver for STOT RE 2 are:
(i) Lead and lead compounds - oral
STOT RE 1; H372: C ≥ 0.5 %
STOT RE 2; H373: 0.05 % ≤ C < 0.5 %
(ii) Cadmium sulfide – oral and inhalation
STOT RE 1; H372: C ≥ 10 %
STOT RE 2; H373: 0.1 % ≤ C < 10 %

Classification of UVCB substances as being toxic to specific target organs is based on the presence of one or more constituents ≥ 1 % classified for STOT RE 1 and the presence of one or more constituents ≥ 10 % classified for STOT RE 2. However, for lead compounds and cadmium sulfide there are specific concentration limits given for STOT RE classification assigned by the lead industry and according to Regulation (EC) 1272/2008 Annex VI, respectively. According to this previously mentioned regulation “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Hence, the SCLs for lead compounds and cadmium sulfide are used for C&L of Matte, precious metal 1. Since, Matte, precious metal 1 contains ≥ 0.05 % but <0.5 % lead and lead compounds and 0.1 – 1 % cadmium sulfide, Matte, precious metal1 meets the classification criteria for STOT RE 2 (H373) as required in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Matte, precious metal 1, derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.