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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
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: Read-across from oral route based on bioelution data
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Acute inhalation toxicity potential of the UVCB substance was determined by reading across from the results of an acute oral toxicity study and information on gastric and alveolar bioaccessibility, resulting in an inhaled acute toxicity estimate.
GLP compliance:
no
Test type:
other: calculation using existing data
Limit test:
no

Test material

Constituent 1
Reference substance name:
Matte, nickel
EC Number:
273-749-6
EC Name:
Matte, nickel
Cas Number:
69012-50-6
Molecular formula:
Not applicable
IUPAC Name:
Nickel matte
Details on test material:
Compositions Tested:

Nickel Sulphidic Matte with Copper >8% (including Cobalt 0.1 -<1%)

Nickel Sulphidic Matte with Copper >8% (including Cobalt ≥1 - <3%)

Nickel Sulphidic Matte (including Cobalt 0.1 -<1%)

Nickel Sulphidic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt 0.1 -<1%)

Nickel Metallic Matte (including Cobalt ≥1 - <3%)

Nickel Metallic Matte (including Cobalt ≥3%)

Reasonable worst-case speciations across industry, as reported in Section 1.2.

Results and discussion

Effect levels
Dose descriptor:
other: Acute Toxicity Estimate (ATE)
Effect level:
> 1 - < 5 mg/L air
Based on:
test mat.
Remarks on result:
other: prediction

Any other information on results incl. tables

The calculations were performed as follows:

Nickel Matte (sulphidic high-copper) group

>5000 mg/kg (oral LD50) X 28.2 % (gastric nickel bioelution percentage) X 30% (gastric nickel absorption) = >423 mg/kg systemically absorbed by oral route

>423 mg/kg X 0.0052 mg/L/4h (CLP extrapolation factor between inhlated and oral routes) = >2.2 mg/L/4hr

>2.2 mg/L/4h / 0.04% (alveolar nickel bioelution percentage) = > 55mg/L/4h

Thus, the oral LD50 for Nickel Matte (sulphidic high-copper) of >5000 mg/kg is equivalent to an inhalation exposure of > 55 mg/L/4h. This indicates that Nickel Matte (sulphidic high-copper) should not be classified for acute toxicity by inhalation, since the classification criteria apply to concentrations less than or equal to 5 mg/l/4hr.

Nickel Matte (sulphidic low-copper) group

>5000 mg/kg (oral LD50) X 42.5 % (gastric nickel bioelution percentage) X 30% (gastric nickel absorption) = >638 mg/kg systemically absorbed by oral route

>638 mg/kg X 0.0052 mg/L/4h (CLP extrapolation factor between inhlated and oral routes) = >3.3 mg/L/4hr

>3.3 mg/L/4h / 0.01% (alveolar nickel bioelution percentage) = > 332 mg/L/4h

Thus, the oral LD50 for Nickel Matte (sulphidic high-copper) of.>5000 mg/kg is equivalent to an inhalation exposure of > 332 mg/L/4h. This indicates that Nickel Matte (sulphidic low-copper) should not be classified for acute toxicity by inhalation, since the classification criteria apply to concentrations less than or equal to 5 mg/l/4hr.

Nickel Matte (metallic)

>5000 mg/kg (oral LD50) X 77.4 % (gastric nickel bioelution percentage) X 30% (gastric nickel absorption) = > 1161 mg/kg systemically absorbed by oral route

>1161 mg/kg X 0.0052 mg/L/4h (CLP extrapolation factor between inhlated and oral routes) = >6.0 mg/L/4hr

>6.0 mg/L/4h / 0.02% (alveolar nickel bioelution percentage) = > 301 mg/L/4h

Thus, the oral LD50 for Nickel Matte (sulphidic high-copper) of.>5000 mg/kg is equivalent to an inhalation exposure of > 301 mg/L/4h. This indicates that Nickel Matte (metallic) should not be classified for acute toxicity by inhalation, since the classification criteria apply to concentrations less than or equal to 5 mg/l/4hr.

Applicant's summary and conclusion

Conclusions:
According to read-across calculations based on oral toxicity and gastric and alveolar bioelution data, the substance is not classified as acutely toxic by inhalation. 
Executive summary:

As Ni matte is considered a UVCB with variable composition, the availability of reliable data on multiple samples, read-across based on bioelution data, and MeClas calculations can be combined to provide important information regarding the potential toxicity of nickel mattes. Taken together, nickel matte is not classified for acute toxicity.

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