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Toxicological Summary

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Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The UVCB is a complex inorganic metals containing substance. The physico-chemical characterization of the UVCB (see relevant section in IUCLID) demonstrates that metal species; intermetallic, metal sulfides resulted in relatively high solubilisation potential in water for most of the metals present in the UVCB.

 

Hazard conclusions for the purpose of classification

 

The UVCB is treated as a complex metal containing substance with a number of discrete constituting compounds (metals, metal compounds, non-metal inorganic compounds). The hazard classifications of each compound are then factored into a combined classification of the UVCB as a whole. For health endpoints, UVCB classifications are based on the combined hazards of the compounds whereby additivity or key cut off levels, specified in look-up tables are used, depending on the endpoint and amount of information available for the constituting compounds. The classification was derived using Meclas (MEtals CLASsification tool - see www.meclas.eu), a calculation tool that follows classification guidance and implementation in accordance to legal rules and technical guidance from ECHA and CLP see IUCLID section 13 attachment for MeClas Classification conclusions.

 

Table28:Summary of the information on toxicological information for the purpose of classification

UVCB constituent

Variabiliy of elemental composition

Classification according each relevant endpoint

Element

Speciation* taken forward for Tier 1 classification

 

 

Ag

Ag massive

Maximum

Not classified

As

As compounds

Maximum

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

 

NiAs

Maximum

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Ca

Ca

Maximum

Not classified

Co

Co

Maximum

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Cu

Cu massive

Maximum

Not classified

 

CuS

Maximum

Self-classification of the speciation, see MECLAS report in CSR Annex I

Fe

Fe/Fe compounds (e.g. FeS2)

Maximum

Not classified

Na

Na2S

Maximum

Harmonised classification of the speciation +self classification for eye damage, see MECLAS report in CSR Annex I

Ni

Ni3S2

Maximum

Self-classification of the speciation, see MECLAS report in CSR Annex I

 

Ni massive

Maximum

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Pb

Lead compounds with the exception of those specified elsewhere in Annex VI

Maximum

Harmonised classification of the speciation +self classification for carcinogenicity, see MECLAS report in CSR Annex I

S

Metal sulphides/sulphates

Maximum

Classification see metal specific entry

Sb

Sb metal

Maximum

Not classified

Se

Se

Maximum

Harmonised classification of the speciation, see MECLAS report in CSR Annex I

Si

Si

Maximum

Not classified

Sn

Sn

Maximum

Not classified

Te

Te

Maximum

Self-classification of the speciation, see MECLAS report in CSR Annex I

Zn

ZnS

Maximum

Not classified

 

·      see IUCLID/CSR section 1.2 composition and IUCLID 4.23 additional Physico-chemical Information

 

Selection of the DNEL(s) for the purpose of risk assessment

 

The UVCB is an intermediate, with a very limited life cycle (manufacturing and industrial uses only). Testing the UVCB is difficult because of the large uncertainty involved when selecting representative samples due to the variable elemental concentrations in the composition of the UVCB.Derivation of a DNEL for the UVCB as such is therefore difficult to interpret and to extrapolateresults of testing to the entirety of variations of the UVCB because of the uncertainty related to the representativeness of the testing. Also, exposure to the UVCB cannot be measured or odeled because of the multi-constituent character of the UVCB. For these reasons, the UVCB toxicological assessment is driven by the assessment of the individual UVCB constituents.

 

The human health assessment is based on all hazardous constituents for human health of the UVCB.

 

The scope of the exposure assessment and type of risk characterization required for workers for each constituent is described in section 9 of this CSR.

 

Table29:Summary of the information on toxicological information for the purpose of risk assessment

 

UVCB constituent

Variability in chemical composition

DNELs for systemic and local effects, inhalation and dermal route, short term and long term.

Element

Speciation used for occupational exposure assessment

As

As compounds

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

 

NiAs

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

Co

Co

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

Na

Na2S

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

Ni

Ni3S2

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

 

Ni massive

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

Pb

Lead compounds with the exception of those specified elsewhere in Annex VI

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in IUCLID and table below

Se

Se

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

Cu

Cu massive

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

 

CuS

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

Zn

ZnS

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

Sn

Sn

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

Sb

Sb metal

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

Te

Te

Hazard assumed as if UVCB consists of 100% worst-case speciation

See respective DNEL summary in table below

 

Different speciation is relevant to consider. In some cases, human health toxicity is driven by free metal ion. In other cases, human health toxicity is different per species and since the speciation of the exposure is not always known, the species with the worst-case DNEL was further considered for the assessment. Toxicological information on the individual UVCB constituents is reported in each constituent summary for which a quantitative exposure and risk assessment was conducted (the information is taken from the respective constituent IUCLID dossiers).

 

The relevant copper speciations for occupational exposure are Cu2+ion, CuS, CuSO4, Cu2O and CuO. There is no difference between the DNEL values of these speciations (apart from the molecular weight conversion). The DNEL values are therefore based on the soluble form. There is no separate DNEL derived for powder form. The common DNEL values are taken forward to risk characterisation.

 

The relevant lead speciations for occupational exposure are lead metal and Pb sulphide. All DNELs are based upon systemic biomarkers of exposure and not on external exposure. The DNEL values used for occupational exposure assessment are therefore based on internal concentration of soluble lead concentrations.

 

Workers can be exposed to arsenic under different speciations i.e. arsenic metal, arsenic sulfide, arsenic sulphate and diarsenic trioxide. Only DNEL values are available for diarsenic trioxide. It is assumed that the arsenic ion is the driver for toxicity. The DNEL for arsenic can therefore be calculated based on the DNEL of arsenic oxide using the molecular weight conversion. These recalculated DNEL values are used for the risk assessment of arsenic. The same rationale holds for antimony.

 

The relevant nickel speciations are Ni metal, Ni sulphates, Ni sulfide and Ni oxide. There are differences in DNEL values between these speciations for a few type of effects. The DNEL values of the worst-case speciation form are therefore taken forward to risk characterisation. Ni sulphate has the lowest systemic acute inhalation DNEL of 16 mg Ni/m3(16-680 mg Ni/m3). Ni sulfide has a DNEL of 0.47 mg/m3for the local acute inhalation effects (range 0.47-4 mg Ni/m3). The local long-term dermal DNEL of 0.00044 mg Ni/cm2/day (range 0.00044 -0.07 mg Ni/cm2/day) is taken forward to risk characterisation.

 

Zn substances are divided in 2 solubility groups: “soluble” substances or “slightly soluble”/“insoluble” substances. The “soluble” DNEL values are selected since these have the lowest (worst-case) DNEL values.

 

SnSO4has the lowest DNEL values compared to SnS and Sn metal and are taken forward to risk characterisation. For Co the same approach has been taken for the relevant metallic, sulfide, sulfate, and oxide speciations.

 

For Ca and Na, these elements are considered to be non-hazardous at the levels of potential exposure. Any potential toxicological effects from these elements are due to the oxide or sulphate speciation. These effects are already covered by the existing metal elements.


Table30: Human health hazard conclusions taken forward to CSA

 

Route

Type of effect

Cu

Pb

As

Ni

Ni metal

NiSO4

NiS

NiO

Assessment rationale for different speciation

Conservative read-across from Cu2+

Lead cation is the primary mediator of lead toxicity

Arsenic ion is the driver for toxicity

Difference between Ni metal and Ni sulphate,

Ni sulphide, Ni oxide

Inhalation

Systemic Long Term

See internal DNEL

See internal DNEL

1.9mg As/m3(read across from As2O3: 5mg/m3)

0.05 mg/m3

(inhalable)

0.05 mg/m3

(inhalable)

0.05 mg/m3

(inhalable)

0.05 mg/m3

(inhalable)

Systemic Acute

20.0 mg/m3

DNEL not relevant (Pb is not acutely toxic)

No hazard

680 mg/m3

16 mg/m3

16.8 mg/m3

520 mg/m3

Local Long Term

OEL

1 mg/m3

DNEL not relevant

DNEL not relevant

0.05 mg/m3

0.05 mg/m3

0.05 mg/m3

0.05 mg/m3

Local Acute

OEL

1 mg/m3

DNEL not relevant (Pb is not acutely toxic)

DNEL not relevant

4 mg/m3

0.7 mg/m3

0.47 mg/m3

3.9 mg/m3

OEL (Long Term)

1 mg/m3

(Inhalable)

0.1-0.2 mg/m3(respirable)

0.05-0.15 mg/m3(Inhalable)

0.01 -0.05 mg/m3(Inhalable)

0.05-1 mg/m3

(Inhalable)

Dermal

Systemic Long Term

137 mg/kg bw/day

See internal DNEL

As2O3: 112μg/kg bw/day

As acid: 85 μg/kg bw/d

Negligible absorption

Negligible absorption

Negligible absorption

Negligible absorption

Systemic Acute

273 mg/kg bw/day

DNEL not relevant (Pb is not acutely toxic)

No hazard

Not relevant (negligible absorption)

Not relevant (negligible absorption)

Not relevant (negligible absorption)

Not relevant (negligible absorption)

Local Long Term

Exposure based waiving

DNEL not relevant

DNEL not relevant

0.07 mg/cm2/day

0.00044 mg/cm2/day

0.0048 mg/cm2

0.024 mg/cm2/day

Local Acute

Exposure based waiving

DNEL not relevant (Pb is not acutely toxic)

DNEL not relevant

Not applicable

Not applicable

Not applicable

Not applicable

Internal

Systemic Long Term

Internal DNEL (using MPPD model) 0.04075 mg/kg/day

DNEL:

Male: 40 μg/dL blood

Female: 30 μg/dLblood

Female of reproductive capacity: 10 μg/dL blood

BLV 0.9739 μg/dL blood, 30 μg/g creatinine in urine

Notassessed (indicative 1μg/dL blood)

 

Eye

Not to be assessed since safety goggle are used where needed.

*PTWI: Provisional Tolerable Weekly Intake (FAO/WHO)

**Arsenic drinking water:http://www.who.int/water_sanitation_health/dwq/chemicals/nitratenitritesum.pdf

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Route

Type of effect

Zn

Sn

Co

Sb

Si

Ag

Se

Fe

Na, Ca

Te

Assessment rationale for different speciation

2 solubility groups:

1) "soluble" substances

2) "slightly soluble" and 'insoluble" substances

Not in multimetallic database

Not in multimetallic database

Read across from antimony trioxide

(Data are for Sb)

Metallic speciation

 

Not in multimetallic database

 

Not in multimetallic database, non-crystalline speciation

Not in multimetallic database,

Inhalation

Systemic Long Term

1.25 mg/m3(soluble)

5 mg/m3(insoluble)

8 mg/m3(SnSO4)

Not derived, since the available data are considered insufficient for a quantitative hazard assessment. Testing proposal is issued.

Not derived

4 mg/m3

0.1mg/m3

0.05 mg/m3

 

No DNEL needs to be derived

cation no hazard, anion covered by metal speciation

Insufficient info, testing proposal

Systemic Acute

No threshold effect and/or no dose-response information available

8 mg/m3(SnSO4)

Not derived. No reason of concern for systemic toxicity because high exposure levels not covered by the long-term DNEL are not expected.

No acute effects

No-threshold effect available

Not derived

/

No DNEL needs to be derived

 

Low hazard (no threshold level)

Local Long Term

No threshold effect and/or no dose-response information available

8 mg/m3(SnSO4)

40 ug/m3Co

0.5 mg/m3

No-threshold effect available

Not derived

/

No DNEL needs to be derived

 

Hazard unknown (no further info necessary)

Local Acute

No threshold effect and/or no dose-response information available

8 mg/m3(SnSO4)

No DNEL derived, since there is no reason of concern for systemic toxicity, because high exposure levels not covered by the long-term DNEL are not expected.

No acute local effects

No-threshold effect available

Not derived

/

No DNEL needs to be derived

 

No hazard identified

OEL (Long Term)

ZnO fume: 4-5 mg/m3

ZnO dust: 3-15 mg/m3

ZnCl: 0.5-5 mg/m3

2 mg/m3

 

0.5mg/m3

No-threshold effect available

Not derived

0.05-0.2mg/m3

No DNEL needs to be derived

 

Insufficient info, testing proposal

Dermal

Systemic Long Term

83.3 mg/kg bw/day

0.11 mg/kg bw/day

(SnSO4)

Not required: overall, there is no reason of concern for systemic toxicity with respect to long-term dermal exposure, because absorption can be regarded as negligible.

234.7 mg Sb/kg bw/day

 

No-threshold effect available

Not derived

7 mg/kg bw/day

No DNEL needs to be derived

 

Hazard unknown (no further information necessary)

Systemic Acute

No threshold effect and/or no dose-response information available

0.11 mg/kg bw/day

(SnSO4)

Not derived, because dermal absorption is negligible and there is no data available which indicate systemic toxicity.

No acute effects

No-threshold effect available

Not derived

/

No DNEL needs to be derived

 

No hazard identified

Local Long Term

No threshold effect and/or no dose-response information available

/

No DNEL derived, because with no dose-response relationship available

No local long term effects expected

No-threshold effect available

Not derived

/

No DNEL needs to be derived

 

Hazard unknown (no further info necessary)

Local Acute

No threshold effect and/or no dose-response information available

/

Not relevant, because no acute local effects are expected.

No acute local effects

 

Not derived

/

 

 

No hazard identified

 

Eye

Not to be assessed since safety goggle are used where needed.

 

 


General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The UVCB is an intermediate, with a very limited life cycle (manufacturing and industrial uses only). Exposure of the general population to the UVCB as such is highly unlikely, derivation of DNELs for the UVCB as such is not appropriate - in addition of being meaningless.