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EC number: 606-384-1 | CAS number: 19797-08-1
- 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
Experimental studies on toxicokinetics are not available. The molecular weight, physicochemical properties including water solubility and octanol-water partition coefficient of the substance suggest that oral, inhalative and dermal absorption occur. The substance is expected to distribute throughout the body due to its high water solubility and low molecular weight. Although the substance is expected to dissolve in lipids, accumulation in adipose tissue due to its log Pow is considered unlikely. Excretion of the test item is expected to occur mainly via urine.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
The theoretical assessment was based on the REACH Guidance: Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c Endpoint specific guidance, taking into account the physical/chemical properties and the toxicity data of the substance.
After
exposure, a substance can enter the body via the gastrointestinal tract,
the lungs, and the skin.
Since different parameters are relevant for absorption via the different
routes of exposure, the uptake via these three routes will be addressed
individually.
After
oral administration, in general, a compound needs to be dissolved before
it can be taken up
from the gastrointestinal tract (1).
Since the water solubility of N-ethylcaprolactam is very high with >1000
g/L at 20 °C, the substance can be expected to completely dissolve into
the gastrointestinal
fluids and become available for uptake. Based on its molecular weight
(approx. 141 g/mol), uptake via passive diffusion (passage of small
water-soluble molecules through aqueous pores or carriage across
membranes with the bulk passage of water) is possible. Nethylcaprolactam
has a moderate partition coefficient (log Pow = 0.6), which implies that
this substance will dissolve in lipids and can thus cross epithelia by
passive diffusion. The substance does not have ionisable groups that
could hamper uptake.
For
risk assessment purposes oral absorption of N-ethylcaprolactam is set at
100%, based on its
high water solubility, its low molecular weight and its moderate log
Pow. The oral toxicity data
do not provide reason to deviate from the proposed oral absorption
factor. Once
absorbed, distribution of the substance throughout the body is expected
based on its high water solubility and moderate molecular weight.
Absorbed N-ethylcaprolactam is expected to be excreted mainly via urine (2).
Based on its moderate partition coefficient (log Pow = 0.6), it is
unlikely that N-ethylcaprolactam will accumulate significantly in
adipose tissue.
N-ethylcaprolactam
has been found to have a low vapour pressure (8.8 Pa at 25 °C), which indicates
that exposure via air is expected to be limited. N-ethylcaprolactam is a
liquid at room temperature, which implies that exposure via aerosols is
possible. Aerosols can reach the tracheobronchial region, in which case
N-ethylcaprolactam will dissolve in the mucus lining the respir atory
tract and will get absorbed. Furthermore, N-ethylcaprolactam can
dissolve in lipids and is therefore able to cross biological membranes.
Taking these considerations intonaccount it is concluded that for risk
assessment purposes as worst case the inhalation absorption of
N-ethylcaprolactam should be set at 100%.
N-ethylcaprolactam is a liquid, which may enable uptake through the skin. The compound’s ability to dissolve in lipids will furthermore favour easy crossing of epidermal barriers. The water solubility of N-ethylcaprolactam is high, allowing partitioning from the stratum corneum into the epidermis. Its moderate molecular size is expected to facilitate uptake through dermal epithelium. According to the criteria given in the REACH Guidance (3), 10% dermal absorption will be considered in case MW >500 and log Pow < -1 or > 4, otherwise 100% dermal absorption should be used. As the physical/chemical properties of N-ethylcaprolactam do not meet the criteria for limited dermal absorption (MW 141.21 g/mol; log Pow = 0.3), for risk assessment purposes dermal absorption should be set at 100%.
References:
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.
2. Parkinson A. In: Casarett and Doull’s Toxicology, The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics. McGraw-Hill, New York, 2001.
3. 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.
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.