Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: Based on the physico-chemical properties and the absence of systemic toxicity in acute and repeated-dose studies, absorption of the study is unlikely.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

There were no studies available in which the toxicokinetic properties of the‘yellow disazo condensation pigments’were investigated. 

The ‘yellow disazo condensation pigments’(molecular weight betweenabout 716 g/mol and 1229 g/mol) are yellow powders at room temperature with an extremely low water solubility (highest measured water solubility of the pigments: < 50 µg/L at 20 °C (CAS 5280-80-8, see chapter "water solubility")). The substances are not prone to hydrolysis and contain the same type of linkages. The data matrices for physico-chemical and toxicological endpoints are provided below:

Tale 1: Overview of physico-chemical data

 

PY 93

PY 94

PY 95

PY 128

PY 155

5580-57-4

5580-58-5

5280-80-8

79953-85-8

68516-73-4

Molecular

weight

937.053 g/mol

957.47 g/mol

916.63 g/mol

1229.18 g/mol

716.65 g/mol

Sate of the substance at 20°C and 101.3 kPa

yellow powder

yellow powder

yellow powder

yellow powder

yellow powder

Melting point

> 300 °C

>300 °C

>300 °C

>300 °C

> 300 °C

Boiling point

Not applicable

(melts above 300 °C)

Not applicable

(melts above 300 °C)

Not applicable

(melts above 300 °C)

Not applicable

(melts above 300 °C)

Not applicable

(melts above 300 °C)

Relative density

1.46 g/cm³

Read-across

PY 93

1.41 g/cm³

1.49 g/cm³

1.45 g/cm³

Vapour pressure

Not relevant

Not relevant

Not relevant

Not relevant

Not relevant

Water solubility

(μg/L)

<10 µg/L at 20 °C

Read-across

PY 93

50 µg/L at 20 °C (Limit of quantification)

<25 µg/L at 23 °C

n.d. (extremely low solubility)

n-octanol solubility

1 µg/L

Read-across

PY 93

50 µg/L

<25 µg/L

not soluble

Log Pow (calculated from solubility)

0

0

0

0

not soluble

Surface tension

Not surface active:

The water solubility is < 1 mg/L

Not surface active:

The water solubility is < 1 mg/L

Not surface active:

The water solubility is < 1 mg/L

Not surface active:

The water solubility is < 1 mg/L

Not surface active:

The water solubility is < 1 mg/L

Flash point

Not relevant

Not relevant

Not relevant

Not relevant

Not relevant

Auto flammability/self-ignition temperature

350 °C at 1013 hPa

Read-across PY 93

350 °C at 1013 hPa

322 °C at 1013 hPa

290 °C at 1013 hPa

Flammability

Non flammable

Non flammable

Non flammable

Non flammable

Non flammable

Explosive properties

Non explosive

Non explosive

Non explosive

Non explosive

Non explosive

Oxidizing properties

No oxidizing properties

No oxidizing properties

No oxidizing properties

No oxidizing properties

No oxidizing properties

Dissociation constant

The substance does not contain any ionic structure

The substance does not contain any ionic structure

The substance does not contain any ionic structure

Not applicable

The substance does not contain any ionic structure


Table 2: Overview of toxicity data

 

PY 93

PY 94

PY 95

PY 128

PY 155

 

5580-57-4

5580-58-5

5280-80-8

79953-85-8

68516-73-4

Skin and eye irritation

Not irritating

K2

Purity: NA

Not irritating

(read-across)

Not irritating

K1/2

Purity: 94.1%

Not irritating

K2

Purity: NA

Not irritating

K2

Purity: NA

Skin sensitization

 

Not sensitizing

K1

Purity: 98%

Not sensitizing (read-across)

Not sensitizing (read-across)

Not sensitizing

(read-across)

Not sensitizing

K1

Purity: NA

Acute oral tox

LD50 >2000 mg/kg bw

K2

Purity: NA

LD50 >2000mg/kg bw

(read-across)

LD50 >5000mg/kg bw

K1

Purity: commercial grade

LD50 >2000mg/kg bw

K2

Purity: NA

LD50 >2000mg/kg bw

K1

Purity: NA, (treated as 100%)

Acute dermal tox

LD50 >2000mg/kg bw

K4

Purity: NA

LD50 >2000mg/kg bw

(read-across)

LD50 >2000mg/kg bw

K4

Purity: NA

LD50 >2000mg/kg bw

(read-across)

LD50 >2000mg/kg bw

(read-across)

Acute inhalation tox

LC50 >1.7 mg/L

K2

Purity: NA

LC50 >1.7 mg/L

(read-across)

LC50 >1.7 mg/L

(read-across)

LC50 >1.7 mg/L

(read-across)

LC50 >1.7 mg/L

(read-across)

Subacute toxicity

NOAEL = 1000mg/kg bw

(OECD 407)

K1

Purity: 98%

NOAEL = 1000mg/kg bw(read-across)

NOAEL = 1000mg/kg bw(read-across)

NOAEL = 1000mg/kg bw(read-across)

NOAEL = 1000mg/kg bw(OECD 422)

K1

Purity: 99.1%

Bacterial mutagenicity

Non mutagenic

K1

Purity: > 97%

Non mutagenic

K1

Purity: > 99%

Non mutagenic

K2

Purity: NA

Non mutagenic

K1

Purity: 97%

Non mutagenic, four strains

K2

Purity: NA, (treated as 100%)

Clastogenicity in vitro

Non clastogenic (read-across)

Non clastogenic (read-across)

Non clastogenic

K1

Purity: 99.4%

Non clastogenic (read-across)

Non clastogenic (read-across)

Mutagenicity in mammalian cells in vitro

Non mutagenic (read-across)

Non mutagenic (read-across)

Non mutagenic

K1

Purity: 99.4%

Non mutagenic (read-across)

Non mutagenic

K1

Purity: NA, (treated as 100%)

Genetic toxicity in vivo

No data available

No data available

No data available

No data available

No data available

Toxicity to reproduction

NOAEL = 1000 mg/kg bw (read-across)

NOAEL = 1000 mg/kg bw (read-across)

NOAEL = 1000 mg/kg bw

(read-across)

NOAEL = 1000 mg/kg bw (read-across)

NOAEL = 1000 mg/kg bw (OECD 422)

K1

Purity: 99.1%

Carcinogenicity

No data available

No data available

No data available

No data available

No data available

Overview of toxicity data on amine building blocks (data sources: *OECD QSAR Toolbox v2.3/literature, **ECHA Dissimination view, accessed Oct 30, 2012 or ***unpublished company data)

 

PY 93

Amine (end)

PY 93, PY 128

Amine

(core)

PY 93,94,95, 128

Amine

(Mid)

PY 155

Amine

(core)

 

PY 94, 95er

Amine (end)

CAS

87-60-5

5307-03-9

2840-28-0

106-50 -3

95-79-4

Acute oral toxicity (LD50, mg/kg bw)

681  ***

1700*** (male/female)

>8000***

Ca 300 (minimum lethal dose = 75)**

630*

Other

 

Methaemoglobin formation postulated

 

 

 

Methaemoglobin formation*

Bacterial mutagenicity

Negative***

Positive***

Negative*

Equivocal*

Negative*

Clastogenicity in vitro

 

 

 

 

Negative*

Mutagenicity in mammalian cells in vitro

 

 

 

 

Negative *

Clastogenicity in vivo (MN)

Negative*

 

 

 Negative**

(OECD 474)

 

Subchronic or chronic toxicity in rats

 

 

 

NOAEL = 16 mg/kg bw (OECD 408)**

LOEL = 125 mg/kg bw (feed, chronic), rat*

Toxicity to reproduction

 

 

 

NOEL(maternal) = 5 mg/kg

NOAEL(developmental) = 10 mg/kg

(OECD 414)** 

 

carcinogenicity

 

 

 

Not carcinogenic*

IARC Cat 3 (not classifyable)

 

Carc Cat 2

CAS 

PY 94

Amine

core

PY 94, PY 95

Amine

end

PY 95

Amine

core

PY 128er

Amine

(end)

PY155er

Amine (mid)

20103-09-7

95-79-4

6393-01-7

349-20-2

none

Acute oral toxicity

(LD50, mg/kg bw)

>5000***

700**

27***

 

 

Acute dermal toxicity (LD50 mg/kg bw)

 

 

 

 

 

Bacterial mutagenicity

 

Negative*, ambiguous**

positive*

 

 

Clastogenicity in vitro

 

Negative**

 

 

 

Mutagenicity in mammalian cells in vitro

 

Negative**

 

 

 

Genotoxicity in vivo

 

 

 

 

 

Repeated dose toxicity

 

 

 

 

 

Toxicity to reproduction

 

 

 

 

 

Carcinogenicity

 

IARC Cat 3 (not classifyable)

 

Carc Cat 2

 

 

 

ABSORPTION

In acute oral toxicity studies done with the‘yellow disazo condensation pigments’common clinical signs as dyspnea, exophthalmos, ruffled fur, curved body position, diarrhea and sedation were seen when the substances were applied in high concentrations. These systemic toxic effects were all transient. No indication of a substance specific systemic toxicity can be found in acute toxicity study in rats with dermal or inhalative administration (see chapter „acute toxicity“) as well as in a subacute toxicity study and a reproductive toxicity screening study in rats with oral application (see chapter „repeated dose toxicity“ and "reproductive toxcity"). Therefore absorption and bioavailability of the test substance after oral administration is not expected (see chapter "acute oral toxicity" and chapter "repeated dose toxicity").

Furthermore, calculation of the dermal absorption potential based on the criteria of the Danish EPA resulted in a very low absorption potential of 10%. Therefore, systemic absorption through the skin is expected to be low.

The test substance is a non-volatile powder at room temperature (the melting point is above 300 °C, see chapter "vapour pressure"). Furthermore, the substances decompose before boiling so that inhalation of test substances vapour is not relevant. In conclusion, based on the physical-chemical properties and the absence of systemic toxicity in acute inhalation studies, absorption of the test substances through the lung are unlikely.

 

DISTRIBUTION

There is no experimental evidence of distribution.

 

METABOLISM

There is no experimental evidence of metabolism. In theory the chemical structure indicates that the most likely route of biotransformation is by reductive cleavage of the azo bond either by bacterial enzymes in the gut or by microsomal azo reductase in the liver. In that theoretical case, uptake and metabolism of these substances should result in the release of aromatic amines. Such compounds have a characteristic toxicity profile as shown in the overview table on amine toxicity above. As no toxicity was observed, the substances are not considered to have been taken up by the body. As a consequence, metabolism is not expected due to lack of absorption after oral administration of the test substance. Studies on genetic toxicity (bacterial reverse mutation assay (Ames-Test), in vitro mammalian cell gene mutation and chromosome aberration test, see chapter “genetic toxicity”) were negative and gave no indications of a reactivity of the test substances or its metabolites under the test conditions (i.e. no increased mutagenicity in treatments with and without metabolic activation).

 

EXCRETION

The observation of yellowish faeces in the repeated oral study is assessed as indication of intestinal passage of the pigment. The extremely low water solubility of the test substance makes absorption from the gastro-intestinal tract unlikely and the substance is expected to be eliminated unchanged (ECHA guidance document R.7c, 2017).