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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro
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 considering mutagenicity of "Slimes and Sludges, precious metal refining" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.5.3.1 “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
Type of assay:
other: prediction from hazard class (calculation)

Test material

Constituent 1
Reference substance name:
Slimes and Sludges, precious metal refining
EC Number:
308-516-0
EC Name:
Slimes and Sludges, precious metal refining
Cas Number:
98072-61-8
IUPAC Name:
Slimes and Sludges, precious metal refining
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
see "confidential details on test material"

Results and discussion

Any other information on results incl. tables

"Slimes and Sludges, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Slimes and Sludges, precious metal refining" 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 “Slimes and Sludges, precious metal refining”.

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:
Interpretation of results (migrated information):
negative

"Slimes and Sludges, precious metal refining" (composition profile 1 - composition profile 2) neither contains any constituent ≥ 0.1 % (w/w) classified as mutagen Muta. 1, nor any constituent ≥ 1 % (w/w) classified as mutagen Muta. 2. In conclusion, "Slimes and Sludges, precious metal refining" ( composition profile 1 - composition profile 2) does not possess mutagenic potential in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of“Slimes and Sludges, precious metal refining ", 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.