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EC number: 221-221-0 | CAS number: 3033-77-0
- 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
Description of key information
Repeated dose toxicity, oral: LOAEL = 3.16 mg/kg bw/day based on (OECD 407, GLP) based on the effects on the kidney proximal convoluted
tubules (vacuolisation, necrosis, hyperplasia) already seen as minimal at 3.16 mg/kg but evident at 10 mg/kg in the kidney .
Repeated dose toxicity, inhalation: no data
Repeated dose toxicity, dermal: no data
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 3.16 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Repeated dose toxicity: oral
One study was available, considered as valid (Kr:2) and was used for Harmonised classification (Degussa, 1990). The study was conducted under GLP regulations and OECD guideline 407 was followed as the study protocol. Wistar rats were administered by oral gavage 0, 3.16, 10.0, 31.6 or 100 mg/kg EPTAC (72.6 %) for 28 days. The control and high dose group had 10 males and 10 female whereas the low- and mid-dose groups had five rats of each sex. Five high and five control group animals also had a 4-week post-exposure observation period. 2,3 -epoxypropyltrimethylammonium chloride (EPTAC) is lethal to rats at a dose of 100 mg/kg bw/day. Reduced food consumption and decreased in body weight gain and slight effects in hematology parameters are considered to be treatment related. Microscopical examinations showed that the kidneys are the most sensitive target organ. Other treatment related changes were mainly observed in organs, that contain fastly dividing cell population (bone marrow, spleen, thymus, gonads, uterus, stomach, intestines. Abnormal mitosis were noted in some of these organs. The findings in stomach and small intestine were attributed to the locally irritant properties to EPATC.
Based on the effects on the kidney proximal convoluted tubules (vacuolisation, necrosis, hyperplasia) already seen as minimal at 3.16 mg/kg but evident at 10 mg/kg in the kidney a LOAEL of 3.16 mg/kg can be set.
EPTAC is therefore classified as STOT RE 2, H373 (May cause damage to organs through prolonged or repeated exposure ) according to criteria of the CLP regulation ((No. 1272/2008 EC), and as Harmful: danger of serious damage to health by prolonged exposure if swallowed, (Xn, R48/22) according to the criteria of Directive 67/548/EEC.
This sub-acute toxicity study in the rats isacceptableand satisfies the guideline requirement for a sub-acute oral study (OECD 407) in rats.
Repeated dose toxicity: inhalation
No data was available.
Repeated dose toxicity: dermal
No data was available.
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
Harmonised classification:
2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) is classified as:
STOT RE 2, H373 (May cause damage to organs through prolonged or repeated exposure ) in the CLP regulation ((No. 1272/2008 EC), Annex VI, Table 3.1) and as Harmful: danger of serious damage to health by prolonged exposure if swallowed, (Xn, R48/22) in the CLP regulation ((No. 1272/2008 EC), Annex VI, Table 3.2).
No additionnal self-classification is proposed
Repeated dose toxicity: dermal and inhalation routes
No-self classification is proposed due to lack of data.
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