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Diss Factsheets

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 for CAS 5280-80-8). 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



0



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).