Titanium dioxide

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.01 % wt; Brown (2020): inhalable dustiness: moderate; thoracic dustiness: very low; respirable dustiness: very low

Key result

Percentile:

other: 0.01 %wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample E171-E is 0.01 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item E171-E (triplicate analysis):

- Average material weight charged to the drum: 19.08 g for 35 cm³

- Inhalable dustiness: moderate (711 mg/kg)

- Thoracic dustiness: very low (<80 mg/kg)

- Respirable dustiness: very low (<10 mg/kg)

Conclusions:

The test item E171-E has a moderate (711 mg/kg) inhalable dustiness, a very low (<80 mg/kg) thoracic dustiness and a very low (<10 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample E171-E was 0.01 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Reference 2

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.01 % wt; Brown (2020): inhalable dustiness: moderate; thoracic dustiness: very low; respirable dustiness: very low

Key result

Percentile:

other: 0.01 %wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G3-1 is 0.01 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G3-1 (triplicate analysis):

- Average material weight charged to the drum: 26.73 g for 35 cm³

- Inhalable dustiness: moderate (1046 mg/kg)

- Thoracic dustiness: very low (<80 mg/kg)

- Respirable dustiness: very low (<10 mg/kg)

Conclusions:

The test item G3-1 has a moderate (1046 mg/kg) inhalable dustiness, a very low (<80 mg/kg) thoracic dustiness and a very low (<10 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G3-1 was 0.01 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Reference 3

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.01 % wt; Brown (2020): inhalable dustiness: moderate; thoracic dustiness: low; respirable dustiness: very low

Key result

Percentile:

other: 0.01 %wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G4-19 is 0.01 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G4-19 (triplicate analysis):

- Average material weight charged to the drum: 30.99 g for 35 cm³

- Inhalable dustiness: moderate (1106 mg/kg)

- Thoracic dustiness: low (131 mg/kg)

- Respirable dustiness: very low (<10 mg/kg)

Conclusions:

The test item G4-19 has a moderate (1106 mg/kg) inhalable dustiness, a low (131 mg/kg) thoracic dustiness and a very low (<10 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G4-19 was 0.01 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Reference 4

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.01 % wt; Brown (2020): inhalable dustiness: low; thoracic dustiness: low; respirable dustiness: very low

Key result

Percentile:

other: 0.01 %wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G5-4 is 0.01 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G5-4 (triplicate analysis):

- Average material weight charged to the drum: 23.74 g for 35 cm³

- Inhalable dustiness: low (516 mg/kg)

- Thoracic dustiness: low (136 mg/kg)

- Respirable dustiness: very low (<10 mg/kg)

Conclusions:

The test item G5-4 has a low (516 mg/kg) inhalable dustiness, a low (136 mg/kg) thoracic dustiness and a very low (<10 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G5-4 was 0.01 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Reference 5

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.08 % wt; Brown (2020): inhalable dustiness: moderate; thoracic dustiness: moderate; respirable dustiness: high

Key result

Percentile:

other: 0.08 % wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G7-5 is 0.08 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G7-5 (triplicate analysis):

- Average material weight charged to the drum: 19.13 g for 35 cm³

- Inhalable dustiness: moderate (1853 mg/kg)

- Thoracic dustiness: moderate (941 mg/kg)

- Respirable dustiness: high (666 mg/kg)

Conclusions:

The test item G7-5 has a moderate (1853 mg/kg) inhalable dustiness, a moderate (941 mg/kg) thoracic dustiness and a high (666 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G7-5 was 0.08 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Reference 6

Endpoint:

particle size distribution (granulometry)

Remarks:

Dustiness

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020-11-16 to 2020-12-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EN15051-2 “Workplace Exposure: Measurement of dustiness of bulk materials – Part 2: Rotating drum method”.

Deviations:

not specified

GLP compliance:

no

Type of method:

rotating drum method

Type of distribution:

mass based distribution

Remarks on result:

other: TDMA (2021): Content of particles with aerodynamic diameter ≤ 10 µm: 0.03 % wt; Brown (2020): inhalable dustiness: moderate; thoracic dustiness: moderate; respirable dustiness: high

Key result

Percentile:

other: 0.03 %wt

Mean:

<= 10 µm

Remarks on result:

other: content of particles with aerodynamic diameter <= 10 µm

TDMA (2021):

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G9-5 is 0.03 % wt (determined by the rotating drum method according to EN 15051-2).

 

Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G9-5 (triplicate analysis):

- Average material weight charged to the drum: 26.43 g for 35 cm³

- Inhalable dustiness: moderate (709 mg/kg)

- Thoracic dustiness: moderate (314 mg/kg)

- Respirable dustiness: high (224 mg/kg)

Conclusions:

The test item G9-5 has a moderate (709 mg/kg) inhalable dustiness, a moderate (314 mg/kg) thoracic dustiness and a high (224 mg/kg) respirable dustiness.

The percent particles below 10 μm aerodynamic diameter using EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G9-5 was 0.03 % wt (determined by the rotating drum method according to EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for particle size distribution (IUCLID section 4.5).

Description of key information

Dustiness:

- Inhalable dustiness: low (516 mg/kg) to high (1853 mg/kg)

- Thoracic dustiness: very low (<80 mg/kg) to moderate (941 mg/kg)

- Respirable dustiness: very low (<10 mg/kg) to high (666 mg/kg)

- Content of particles with aerodynamic diameter ≤ 10 μm: 0.01 - 0.08 % wt (EN 15051-2).

On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), these titanium dioxide forms do not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report.