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Description of key information

 No information on animal testing for skin and eye irritation of “Matte leaching residue" is available. The approach followed on C&L of UVCB substances as irritant or corrosive to skin and eye in case where data are available on the constituents, but not on the UVCB substance as a whole, is based on the theory of additivity (CLP guideline, section 3.2.3.2.3.2, November 2013). Hence, The UVCB substance “Matte leaching residue" composition profile 1&3) has to be classified as skin irritant Skin Irrit. 2 (causes skin irritation) and has to be labelled with H315. Furthermore, the substance “Matte leaching residue" (composition profile 1&3) has to be classified as Eye Damage 1 (Causes serious eye damage) in accordance with Regulation (EC) 1272/2008 (theory of additivity was applied) and labelled with H318. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, 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:
Skin irritation/corrosion 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
Remarks on result:
not measured/tested
Remarks on result:
not measured/tested

According to MeClas the substance is classified as Skin corrosive/irritant Cat 2 - H315.

Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as Skin corrosive/irritant Cat 2 - H315.
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 (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, 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:
Eye irritation/corrosion 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
Remarks on result:
not measured/tested
Remarks on result:
not measured/tested

According to MeClas, the substance is classified as Eye corrosive/irritant Cat1 - H318.

Conclusions:
The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as Eye corrosive/irritant Cat1 - H318..
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 (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Irritation/Corrosion". 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 “theory of additivity" (Regulation (EC) No 1272/2008, section 3.2.3.and 3.3.3.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. Thus, for “Matte leaching residue" one C&L entry for skin irritation (i.e., Skin Irrit. 2) and two C&L entries for eye irritation (i.e., Eye irrit. 2 and Eye damage1) were calculated. Each group is described in a separate endpoint study record and endpoint summary.


Effects on skin irritation/corrosion:irritating

Effects on eye irritation:corrosive

Justification for classification or non-classification

Skin irritation:
The UVCB substance“Matte leaching residue" (composition profile 1&3) meets classification criteria as Skin Irrit. 2 (causes skin irritation) in accordance with Regulation (EC) 1272/2008 (theory of additivity was applied) and requires labelling with H315.

Eye irritation:
The UVCB substance“Matte leaching residue" (composition profile 1&3) meets classification criteria as Eye Damage 1 (Causes serious eye damage) in accordance withRegulation (EC) 1272/2008(theory of additivity was applied) and labelled with H318.

 

Respiratory irritation:

The generic term respiratory tract irritation (RTI) covers two different effects: (i) sensory irritation and (ii) local cytotoxic effects. The classification is usually covered under the endpoint specific target organ toxicity- single exposure (endpoint IUCLID 7.2) and - repeated exposure (endpoint IUCLID 7.5). Please refer to the endpoint summaries on acute toxicity and repeated dose toxicity for further information.

 

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