Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Theoretical assessment
- Adequacy of study:
- key study
- Study period:
- 07 October 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP assessment report based on expert judgement
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- An expert assessment was made based on all data available.
- GLP compliance:
- no
Test material
- Reference substance name:
- N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide
- Molecular formula:
- C29H27N3O4S
- IUPAC Name:
- N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Off-white powder
- Storage condition: At room temperature protected from light
Constituent 1
Test animals
- Species:
- other: none
Administration / exposure
- Route of administration:
- other: Oral, dermal and inhalation
- Vehicle:
- other: Not applicable
- Details on study design:
- A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data of the substance.
Results and discussion
Any other information on results incl. tables
After exposure, a substance can enter the body via the gastrointestinal tract, the lungs and the skin. Since different parameters are relevant to estimate adsorption depending on the route of exposure, the three routes will be addressed individually.
In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration1. Pergafast 425 has a relatively high molecular weight (513.6), which will limit passage through biological membranes. Pergafast 425 shows low water solubility of 0.00474 mg/L and a high partition coefficient (Log Pow: 4.3) which makes the substance not favorable for absorption by the GI-tract via passive diffusion.
However, the substance could be taken up via micellular solubilization by bile salts and uptake via the lymphatic system or transport via pinocytosis. Based on these physicochemical properties of Pergafast 425, a moderate uptake by the GI-tract is anticipated, and for risk assessment purposes the oral absorption of Pergafast 425 is set at 50%. The results of the toxicity studies do not provide reasons to deviate from the proposed oral absorption.
For inhaled substances the process of deposition of the substance on the surface of the respiratory tract and the actual absorption have to be differentiated. Pergafast 425 has a low vapour pressure (20°C: < 8.4 x 10-7 Pa) and was found to decompose before a boiling point was reached, which indicates that the substance is not very volatile and exposure to the substance as a vapour is unlikely. Pergafast 425 is a powder. Since 90% of the particles is smaller than 55.0 μM, the largest part of the substance has the potential to be inhaled and may reach the thoric region. Furthermore, 50% is smaller than 12.9 μM, which means that at least 50% of the substance may reach the alveolar region of the respiratory tract. If these particles reach these regions, Pergafast 425 is likely to be taken up via micellular solubilization.
Therefore, it is concluded that for risk assessment purposes the inhalation absorption of Pergafast 425 is set at 100%.
As Pergafast 425 is a powder, uptake through the skin is unlikely to occur unless it is dissolved in a body fluid (sweat). Pergafast 425 is poorly soluble in water (below 1 mg/L), therefore is the partition from the stratum corneum into the epidermis is expected to be limited. Its ability to dissolve in lipids will favour uptake into stratum corneum. Its high molecular weight makes the substance not favourable for dermal uptake. According to the guidance2, a default value of 10% skin absorption is used when the molecular mass is above 500 and log Pow is outside the range [-1, 4]. Since the substance has a molecular weight of 513.6 and a log Pow of 4.3, it those meet both criteria and the dermal absorption of Pergafast 425 for risk assessment purposes is thus set at 10%. The dermal toxicity data do not provide reason to deviate from the proposed dermal absorption factor.
Generally, substances with a high log Pow value have long biological half-lives. Daily exposure to substances with a log Pow of around 4 or higher could result in a buildup of that substance within the body. Pergafast 425 showed a BCF below 100, which indicates a low bioaccumulation potential. Therefore, the bioaccumulation potential of Pergafast 425 is expected to be low.
REFERENCES
Ref. 1 Martinez MN, Amidon GL. Mechanistic approach to understanding the factors
affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42:
620-43.
Ref. 2 Guidance for the implementation of REACH. Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific
guidance. European Chemical Agency, Version 6.0 November 2016.
Applicant's summary and conclusion
- Conclusions:
- A toxicokinetic assessment was performed based on the available data of the substance.
Based on the physical/chemical properties of the substance, absorption factors for this
substance are derived to be 50% (oral), 100% (inhalation) and 10% (dermal) for risk
assessment purposes. The bioaccumulation potential is expected to be low.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.