Registration Dossier

Administrative data

Description of key information

No information on animal testing of "Slags, precious metal" refining is available. However, "Slags, precious metal refining" contained lead compounds, nickel oxide and crystalline respirable silica with concentration relevant for STOT RE classification of mixture. 

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
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for toxic to specific target organ after repeated dose application of "Slags, precious metal refining" 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
Critical effects observed:
not specified

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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.

Conclusions:
Classification driver for STOT RE 1 are:
(i) Lead and lead compounds - oral (both grades)
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%
(ii) Silica – crystalline respirable (position paper -www.crystallinesilica.eu) - inhalation (both grades)
STOT RE 1; H372: C ≥ 10%
STOT RE 2; H373: 1% ≤ C < 10%

(iii) Nickel oxide – 1stATP - inhalation (grade 1)

Classification of UVCB substances as being toxic to specific target organs after repeated dose application 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 there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification.

The classification driver for STOT RE classification of “Slags, precious metal refining” (composition profile 1 - composition profile 2) are lead and lead compounds (oral route) and crystalline, respirable silica (inhalation route) in concentration relevant for C&L as STOT RE 1. An additional driver is nickel oxide for grade 1. Therefore, “Slags, precious metal refining” meets classification criteria as STOT RE 1 and requires labelling with H372 (causes damage to organs).

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Slags, 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for toxic to specific target organ after repeated dose application of "Slags, precious metal refining" 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
Critical effects observed:
not specified

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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.

Conclusions:
Classification driver for STOT RE 1 are:
(i) Lead and lead compounds - oral (both grades)
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%
(ii) Silica – crystalline respirable (position paper -www.crystallinesilica.eu) - inhalation (both grades)
STOT RE 1; H372: C ≥ 10%
STOT RE 2; H373: 1% ≤ C < 10%

(iii) Nickel oxide – 1stATP - inhalation (grade 1)

Classification of UVCB substances as being toxic to specific target organs after repeated dose application 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 there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification.

The classification driver for STOT RE classification of “Slags, precious metal refining” (composition profile 1 - composition profile 2) are lead and lead compounds (oral route) and crystalline, respirable silica (inhalation route) in concentration relevant for C&L as STOT RE 1. An additional driver is nickel oxide for grade 1. Therefore, “Slags, precious metal refining” meets classification criteria as STOT RE 1 and requires labelling with H372 (causes damage to organs).
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Slags, 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
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:
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 "Slags, precious metal refining" 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 of these constituents it was decided to use the classification information from the individual constituents and to 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. This approach has been presented and discussed with ECHA in several meetings.

In total, two different grades of "Slags, precious metal refining" (composition profile 1 – composition profile 2) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Based on the composition profiles 1 & 2 for "Slags, precious metal refining" one C&L entry (one for inhalation toxicity and one for dermal toxicity) for specific target organs toxicity (i.e., STOT RE 1) was generated.


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 oxide, silica (crystalline, respirable)

Justification for classification or non-classification

Classification driver for STOT RE 1 are:

(i) Lead and lead compounds - oral (both grades)

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

STOT RE 1; H372: C ≥ 0.5%

STOT RE 2; H373: 0.05% ≤ C < 0.5%

(ii) Silica – crystalline respirable (position paper -www.crystallinesilica.eu) - inhalation (both grades)

STOT RE 1; H372: C ≥ 10%

STOT RE 2; H373: 1% ≤ C < 10%

 

(iii) Nickel oxide – 1stATP - inhalation (grade 1)

 

Classification of UVCB substances as being toxic to specific target organs after repeated dose application 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 there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification.

 

The classification driver for STOT RE classification of “Slags, precious metal refining” (composition profile 1 - composition profile 2) are lead and lead compounds (oral route) and crystalline, respirable silica (inhalation route) in concentration relevant for C&L as STOT RE 1. An additional driver is nickel oxide for grade 1. Therefore, “Slags, precious metal refining” meets classification criteria as STOT RE 1 and requires labelling with H372 (causes damage to organs).