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 substances of the disazocondensation pigment yellow category were investigated. 

The substances of the disazocondensation pigment yellow category (molecular weight between about 716 g/mol and 1229 g/mol) are yellow powders at room temperature with an extremely low water solubility (highest measured water solubility in this category: < 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:

 

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

1229.17 g/mol

716.65 g/mol

State 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 densitiy

1.46 g/cm³

1.46 g/cm³

1.41 g/cm³

1.49 g/cm³

1.45 g/cm³

Vapour pressure

Not relevant

Not relevant

Not relevant

Not relevant

Not relevant

Log Pow (calculated from solubilities)

0

1.77

0

0

not measurable

Water solubility

< 10 µg/L at 20 °C

< 10 µg/L at 20 °C

< 0.05 mg/L (detection limit)

< 0.025 mg/L

not soluble

n-octanol solubility

< 0.01 mg/L

0.001 mg/L

< 0.05 mg/L

< 0.025 mg/L

not soluble

Surface tension

The water solubility is < 1mg/l.

Not surface active: The water solubility is < 1mg/L

Not surface active: The water solubility is < 1mg/L

Not surface active: The water solubility is < 1mg/L

Not surface active: The water solubility is < 1mg/L

Flash point

Not relevant

Not relevant

Not relevant

Not relevant

Not relevant

Auto flammability/self-ignition temperature

350°C at 1013 hPa

350°C at 1013 hPa

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

Oxidising 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.


 

PY 93

PY 94

PY 95

PY 128

155

5580-57-4

5580-58-5

5280-80-8

79953-85-8

68516-73-4

Skin and eye irritation

Not irritating

K2

Not irritating

(read across)

Not irritating

K1/2

Not irritating

K2

Not irritating

K2

Skin sensitzation

Not sensitizing

K1

Not sensitizing

(read across)

Not sensitizing

(read across)

Not sensitizing

(read across)

Not sensitizing

 K1

acute oral tox (LD50 in mg/kg bw)

> 15000

K2

> 2000

(read across)

> 5000

K1

> 5000

K2

> 2000

 K1

 

acute dermal tox (LD50 in mg/kg bw)

> 5000

K4

> 5000

(read across)

> 5000

K4

> 5000

(read across)

> 5000

(read across)

acute inhalation tox

LC50 > 1.7 mg/L

K2

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 = 1000

K1 (OECD 407)

NOAEL = 1000

(read across)

NOAEL = 1000

(read across)

NOAEL = 1000

(read across)

NOAEL = 1000

K1 (OECD422)

Bacterial mutagenicity

Non mutagenic

K1

Non Prival

Non mutagenic

K1

Prival

Non mutagenic

K2

Non Prival

Non mutagenic

K1

Non Prival

Non mutagenic, four strains

K2

Non Prival

Clastogenicity in vitro

 

Non clastogenic

(read across)

 

Non clastogenic

(read across)

 

Non clastogenic

K1

 

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

 

Non mutagenic

(read across)

Non mutagenic

K1

 

Genetic toxicitiy

in vivo

No data available

No data available

No data available

No data available

No data available

Toxicity to reproduction

(OECD 422)

NOAEL = 1000

(read across)

NOAEL = 1000

(read across)

NOAEL = 1000

(read across)

NOAEL = 1000

(read across)

NOAEL = 1000

K1

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*

 

 

 

 

Subchronic or chronic toxicity in rats

 

 

 

NOAEL = 16 mg/kg bw (OECD 408).NOAEL < 25 mg/kg bw (chronic) (Spleen, liver and kidney) *

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

Toxicity to reproduction

 

 

 

 

 

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 substances of the disazocondensation pigement yellow category 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. Furthermore, uptake and metabolism of these substances should result in the release of aromatic amines. Such compounds have a characteristic toxicity profile. As this was not observed, the substances are not considered to have been taken up by the body. So 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 7c, 2008).