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EC number: 939-992-3 | CAS number: 1195028-55-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The toxicokinetics of the substance CAS 1195028-55-7/ EC 939-992-3 has been assessed based on the physicochemical properties and available toxicological data following the ECHA Guidance R.7c from November 2012 (version 1.1).
As a result, it has been found that the substance is expected to be absorbed from the gastro-intestinal tract. The respiratory deposition is assessed to be low and the dermal absorption could occur on certain extent.
Distribution in the body is expected to take place, mainly based upon the water solubility and the clinical observations and target organs seen in the toxicity studies.
Limited data were available for estimation of metabolism (increased kidney weights were observed in rats). Based on the chemical structure it is known that the present double bonds -C=C- or –N=N- might react with strong acids (pH << 4) to give new structures. From the biodegradability testing it was concluded that the test item was not readily biodegradable but showed biodegradation and is considered as inherently biodegradable. Bioaccumulation is not expected, based on the log Kow and the calculated BCF values.
Based on the physicochemical properties of the substance only one route of excretion (urine) was assessed as possible.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 50
Additional information
The assessment below is based on theECHA Guidance on information requirements and chemical safety assessment (Chapter R.7c: Endpoint specific guidance, November 2012 Version 1.1), for which physicochemical data may be used for a qualitative Toxicokinetics assessment. All data needed are part of the REACH registration dossier of the substance.
Absorptionof CAS 1195028 -55 -7/ EC 939 -992 -31 was assessed based on physicochemical and available toxicological data. The substance is a solid with a molecular weight of ca 1155 and a water solubility of 149 g/L. The octanol-water partition coefficient (log Kow) is -4.47. These values of log Kowand molecular mass of the substance don’t suggest an absorption into the body.
(a) Oral/GI absorption:
The compound is ionisable and highly soluble in water. Its high molecular weight and because of the log Kowvalue of -4.47 (not in the range -1 to 4), the compound should not be easily involved in a micellular solubilisation and this fact doesn’t favor the oral absorption.
No signs of toxicity appeared in acute oral toxicity studies that support the substance is not easily absorbed by oral route. However there are certain signs of toxicity in repeated dose toxicity studies that indicate the compound is absorbed from the gastro-intestinal tract in a certain level.
The considered value for Chemical Safety Assessment of oral absorption 50% is the value taken from the ECHA Guidance.
(b) Respiratory absorption:
N-octanol/water partition coefficient and molecular weight of the substance doesn’t favor absorption. The substance is a solid and not volatile and it is not expected a high exposure by inhalation route. However if some of the substance is inhaled, it can be expected to be absorbed, based on the high solubility. In practice, absorption is assumed to be low based on the physical properties and the physical status (solid) with a particle size >100 μm.
The considered value for Chemical Safety Assessment of inhalation absorption 50% is considered to better reflect the substance behaviour than the value of the ECHA Guidance proposed to be 100%.
(c) Dermal absorption:
This route of exposure is the most probable one.
Based upon the fact that the substance is a solid with a high molecular weight, log Kowof -4.47 and not showing skin irritation, sensitization and/or acute dermal toxicity, it might be expected that the substance is not absorbed by the skin. The dermal absorption degree is increased when the substance is in a water solution form.
Having all this factors into account the dermal absorption is considered to be low to moderate.
The value considered for Chemical Safety Assessment of dermal absorption is the value proposed in ECHA Guidance for dermal absorption, 50%.
For the assessment of distribution, metabolism and excretion, physicochemical and available toxicological properties are also taken into account according to ECHA guidance Chapter R.7c.
Distribution:
Based upon the molecular weight ca.1155 g/mol, high water solubility of 149 g/L and logKowof -4.47, distribution in the body is expected to take place slowly but in certain extent. This is further confirmed by effects in clear target organs (kidneys) and observations from the toxicity studies.
Metabolism and accumulation potential:
Metabolism
cannot be deduced from the data available, except for the increase in
kidney weights in male and female rats dosed at 750 mg/kg bw and 300
mg/kg bw day, and haemotogical changes in the repeated dose toxicity
study.
Regarding bioaccumulation potential, the available data from biodegradation studies show that although the substance can’t be classified as “readily biodegradable” a 48% of degradation is observed after 21 days and the substance will biodegrade along time. The BCF calculated value is 3.162 L/kg ww, which is well below the threshold value of 2000 L/kg for a PBT substance as indicated by the REACH Guidance on PBT assessment. Therefore, the substance is not expected to bio-accumulate in the body.
Excretion:
Based
on the high molecular weight and pKavalue the urinary
excretion of the parent compound would not be expected. However the high
water solubility, could favor this route of elimination. Excretion via
the saliva and sweat is considered less possible based on the low log Kowvalue
(-4.45). Also
exfoliation should not be applicable. Excretion in the breast milk is
not considered to be the main route. Therefore only one route of
excretion is available to reduce the substance in the body.
However it should be considered that the substance could be degraded at gastro-intestinaI pH 1-4 and won’t be eliminated as such.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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