Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Type of composition:

boundary composition of the substance

State / form:

solid: nanoform

Reference substance:

calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Type of information reported:

single nanoform

Name of nanoform:

Pigment Red 247 - joint submission

Shape category:

spheroidal

Remarks:

multimodal shapes containing >85 - <100% spheroidal and >0-<15% elongated particles

Shape:

cubic

Pure shape:

no

Range:

> 60 - < 100 %

Shape category:

spheroidal

Remarks:

multimodal shapes containing >85 - <100% spheroidal and >0-<15% elongated particles

Shape:

spherical

Pure shape:

no

Range:

> 0 - < 25 %

Shape category:

elongated

Remarks:

multimodal shapes containing >85 - <100% spheroidal and >0-<15% elongated particles

Shape:

rod

Pure shape:

no

Range:

> 0 - < 15 %

Shape category:

spheroidal

Remarks:

multimodal shapes containing >85 - <100% spheroidal and >0-<15% elongated particles

Percentile:

D10

Range:

ca. 0.015 - ca. 0.095 μm

Percentile:

D50

Range:

ca. 0.05 - ca. 0.095 μm

Percentile:

D90

Range:

ca. 0.085 - ca. 0.165 μm

Fraction of constituent particles in the size range 1-100 nm:

ca. 50 - ca. 100 %

Shape category:

elongated

Remarks:

multimodal shapes containing >85 - <100% spheroidal and >0-<15% elongated particles

Percentile:

D10

Range:

ca. 0.015 - ca. 0.095 μm

Percentile:

D50

Range:

ca. 0.05 - ca. 0.095 μm

Percentile:

D90

Range:

ca. 0.085 - ca. 0.165 μm

Range of length:

ca. 0.115 - ca. 0.445 μm

Range of aspect ratio (:1):

>= 3 - <= 4.5

Fraction of constituent particles in the size range 1-100 nm:

ca. 50 - ca. 100 %

Structure:

crystalline

Name:

Pigment Red 247

Pure structure:

yes

Range of specific surface area:

>= 5 - <= 200 m²/g

Surface treatment applied:

no

Reference 2

Name:

calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Type of composition:

legal entity composition of the substance

State / form:

solid: nanoform

Related composition:

calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Reference substance:

calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Type of information reported:

single nanoform

Name of nanoform:

Pigment Red 247 - joint submission

Shape category:

spheroidal

Remarks:

multimodal shapes containing about 92% spheroidal particles and about 8% elongated particles

Shape:

cubic

Pure shape:

no

Typical composition:

ca. 69.6 %

Range:

> 60 - < 100 %

Shape category:

spheroidal

Remarks:

multimodal shapes containing about 92% spheroidal particles and about 8% elongated particles

Shape:

spherical

Pure shape:

no

Typical composition:

ca. 22.4 %

Range:

> 0 - < 25 %

Shape category:

elongated

Remarks:

multimodal shapes containing about 92% spheroidal particles and about 8% elongated particles

Shape:

rod

Pure shape:

no

Typical composition:

ca. 8 %

Range:

> 0 - < 15 %

Shape category:

spheroidal

Percentile:

D10

Typical value:

ca. 0.056 μm

Range:

ca. 0.03 - ca. 0.08 μm

Percentile:

D50

Typical value:

ca. 0.088 μm

Range:

ca. 0.06 - ca. 0.1 μm

Percentile:

D90

Typical value:

ca. 0.126 μm

Range:

ca. 0.1 - ca. 0.155 μm

Additional information:

The determined particle size distribution relates to both shape categories. Due to the very low number of elongated particles, no separate evaluation for rods had been conducted. The smallest dimension of all particles had been considered.

Fraction of constituent particles in the size range 1-100 nm:

ca. 50 - ca. 100 %

Shape category:

elongated

Percentile:

D10

Typical value:

ca. 0.056 μm

Range:

ca. 0.03 - ca. 0.08 μm

Percentile:

D50

Typical value:

ca. 0.088 μm

Range:

ca. 0.06 - ca. 0.1 μm

Percentile:

D90

Typical value:

ca. 0.126 μm

Range:

ca. 0.1 - ca. 0.155 μm

Typical length:

ca. 0.281 μm

Range of length:

ca. 0.155 - ca. 0.305 μm

Typical aspect ratio (:1):

>= 3.5 :1

Range of aspect ratio (:1):

>= 3 - <= 4.3

Additional information:

The determined particle size distribution relates to both shape categories. Due to the very low number of elongated particles, no separate evaluation for rods had been conducted. The smallest dimension of all particles had been considered.

Fraction of constituent particles in the size range 1-100 nm:

ca. 50 - ca. 100 %

Structure:

crystalline

Name:

Pigment Red 247

Pure structure:

yes

Crystal system:

other: unknown

Typical specific surface area:

ca. 27 m²/g

Range of specific surface area:

>= 19 - <= 35 m²/g

Skeletal density:

1.432 g/cm³

Surface treatment applied:

no

PBT status:

the substance is not PBT / vPvB

Justification:

Potentially P

From the data presented on biodegradation (IUCLID section 5.2) it was concluded that the substance is potentially (v)P.

 

- Not B/vB

From the data on bioaccumulation (IUCLID section 5.3) and the log Kow it was concluded that the substance is neither bioaccumulative (not B) nor very bioaccumulative (not vB).

 

- Not T

Based on the results of the aquatic toxicity studies (IUCLID section 6.1) the substance was considered not toxic (not T). Also, relevant mammalian toxicity studies (see (IUCLID section 7) showed no toxicity for long-term endpoints, ruling out the conclusion of being toxic according to Annex XIII of REACH.

 

In conclusion, the submission substance is not PBT / vPvB according to Annex XIII of REACH.

Likely routes of exposure:

 

The submission substances are not PBT or vPvB. Therefore no emission characterisation is required.