Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No information on animal testing of “Matte leaching residue" is available. “Matte leaching residue" contains ≥ 1 % nickel sulfate (specific concentration limits of nickel sulfate; see "justification for classification and non-classification" below). Nickel sulfate with a content ≥ 1% meets the classification criteria for STOT RE 1 via the inhalation route that triggers therefore C&L as STOT RE 1 for all composition profiles of “Matte leaching residue".
However, “Matte leaching residue" with a lead and lead compound content of ≥ 0.3% is considered to be toxic to specific target organs following repeated dosing via the oral route and requires labelling with STOT-RE (specific concentration limits of lead compounds; see "justification for classification and non-classification" below), in accordance with Regulation (EC) 1272/2008.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral, 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
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
Repeated dose toxicity potential of the UVCB 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
Remarks on result:
not measured/tested
Critical effects observed:
not specified

 According to MeClas the substance is classified as STOT-RE Cat. 1 - H372.

Conclusions:
The study provides a conservative estimate of the repeated specific target organ toxicity. The analysed UVCB sample is classified for STOT-RE Cat. 1.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation, other
Remarks:
other: predicted 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
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
Repeated dose toxicity potential of the UVCB 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
Remarks on result:
not measured/tested
Critical effects observed:
not specified

According to MeClas the substance is classified as STOT-RE Cat. 1 - H372.

Conclusions:
The study provides a conservative estimate of the repeated specific target organ toxicity. The analysed UVCB sample is classified for STOT-RE Cat. 1.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Repeated Dose Toxicity". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L it was agreed within the consortium to use the classification information from the individual constituents and calculate the resulting classification by using the generic concentration limits of ingredients of the mixture classified as a specific target organ toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.9.3.4. “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool.

In total three different“Matte leaching residue"grades were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. However, for“Matte leaching residue" onlyone C&L entry (STOT RE 1, oral and inhalation route) for repeated dose toxicity was generated, since all composition profiles contains substances in a content relevant for C&L in category STOT RE 1.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
i.e., lead and lead compounds

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
i.e., nickel sulfate

Justification for classification or non-classification

General notes:

According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification (oral) are as follows:

STOT RE 1; H372: C ≥ 0.5 %

STOT RE 2; H373: 0.05 % ≤ C < 0.5 %

 

According to the self-classification of nickel sulfate the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:

STOT RE 1; H372: C ≥ 1 %

STOT RE 2; H373: 0.1 % ≤ C < 1 %

 

Therefore, the following C&L driver were identified for “Matte leaching residue":

(i) classification driver: lead and lead compounds (oral route; systemic effects):

(ii):classification driver: nickel sulfate (inhalation route; local effects)

 

Classification of UVCB substances as being toxic to specific target organs after repeated dosing is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. However, for lead compounds and nickel sulfate there are specific concentration limits given for STOT RE classification assigned by the lead industry and in accordance to Regulation (EC) 1272/2008 Annex VI, respectively. According to CLP “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Hence, theSCLsfor lead compounds and nickel sulfate are used for C&L of“Matte leaching residue".

 

“Matte leaching residue" contains lead and lead compounds in concentrations relevant for C&L (lead compounds ≥0.3 %). Furthermore,“Matte leaching residue" contains nickel sulfate with a content ≥1 %. In conclusion,“Matte leaching residue”, meets classification criteria for specific target organs toxicity and requires classification as STOT RE 1 (H372).