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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
Carcinogenicity
Administrative data
Description of key information
In a two-year cancer study, EPTAC was applied on CF1 mouse skin (Kr: 2, Doak, 1983): EPTAC is a skin carcinogen, probably; it is also a systemic carcinogen. EPTAC is classified as carcinogen in the Annex VI of the CLP regulation (1272/2008/EC).
Key value for chemical safety assessment
Carcinogenicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- BMD05
- 9.7 mg/kg bw/day
Justification for classification or non-classification
Harmonised classification:
EPTAC is classified as carcinogenic Cat.1B, H350 (may cause cancer) in the Annex VI, Table 3.1 of the CLP regulation (1272/2008/EC) and as carcinogenic Cat.2, R45 in the Annex VI, Table 3.2 of the CLP regulation (1272/2008/EC).
No additionnal self-classification is proposed
Additional information
Carcinogenicity: dermal
One study was available, considered as valid (Kr:2) and was used for Harmonised classification (Doak, 1983).
In a two-year cancer study, EPTAC was applied on CF1 mouse skin at concentrations 0.1, 0.3 and 1.0% (w/v) (1% was a nonirritant concentration in a pre-test). Each dose level had 50 male and 50 female mice, except the solvent (ethanol/nonident) which had 100 mice per group and sex. A concentration of 10 mg/ml beta-propiolactone was used to act as the positive control. The test and control substances were applied twice weekly, 0.2 ml at a time, and the treatment continued for up to 104 weeks. Expressed as weight the doses are 0.2, 0.6, 2.0 mg/animal/application. In the absence of data on average animal weight during the exposure (no weight records were available and there is no mention that these data was collected), we use an average weight TGD default assumption of 40 g. Using this assumption, the doses are 5, 15 and 50 mg/kg/application or 10, 30 and 100 mg/kg/week. Based on the in vitro absorption assay with mouse skin, 22.6 to 43.6 % of CHPTAC ((3-chloro-2-hydroxypropyl)trimethylammonium chloride) passed through the skin at this concentration. The clinical observations were made twice daily and detailed records of skin lesions and site were kept. In necropsy, a macroscopical examination was performed and when gross abnormalities were found the organ was sectioned for microscopical preparation. At histological examination, a distinction between malignant and benign tumours was made and the tumours were grouped as either originating from the treated site or from an untreated area.Decreased survival time were observed especially among females. There was a statistically significant increase of skin tumours when mice where treated topically with 1 % EPTAC (~50 mg/kg/application). In females, there was also a statistically significant increase of lung tumours, mammary gland tumours, lachrymal gland tumours and reticulum cell sarcoma in the 1 % EPTAC treatment group. Of systemic tumours, a statistically significantly increased number of thymic lymphosarcoma in males of the 1 % dose group was reported. Although EPTAC is a genotoxic, the mode of action, which caused the occurrence of the systemic tumours, is somewhat unsure. While authors speculated viral interaction may have been involved, it is also unsure whether EPTAC reaches the body further than the dermis in sufficient quantities to have caused the systemic tumours. Because EPTAC is a mutagen, the mode of action of the tumour formation is presumed not to have a threshold. A BMD0.1 (5d) of 9.7 mg/kg bw (malignant and benign tumours combined) can be used in the risk characterisation.
EPTAC is classified as carcinogenic Cat1B, H350 (May cause cancer) according to the criteria of the CLP regulation (1272/2008/EC) and as carcinogenic, Cat.2, R45according to criteria of the Directive 67/548/EEC.
Carcinogenicity: oral and inhalation routes
No data was available.
Carcinogenicity: via dermal route (target organ): other: skin
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