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EC number: 303-085-5 | CAS number: 94158-14-2
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline no. 427 (Draft, 2000)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
- EC Number:
- 303-085-5
- EC Name:
- 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
- Cas Number:
- 94158-14-2
- Molecular formula:
- C9H11NO3.ClH
- IUPAC Name:
- 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
- Test material form:
- solid: crystalline
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar Kyoto (WKY)
- Sex:
- female
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: acetone/water 1:1
- Details on exposure:
- Dermal application: Approximately 24 h prior to treatment, a 5 x 6 cm area of the fur on the back of the animals and a 4 x 4 cm area of the fur in the abdominal region was shaved. On the shaved skin on the back an area of 2.5 x 4 cm was marked as application site. The shaved area in the abdominal region served as negative control. Immediately prior to treatment, the application site was cleaned with a 10 % shampoo solution and water, and then dried. 10 mg/kg bw (1.5 % Hydroxyethyl-3,4-Methylenedioxyaniline HCl in acetone/water 1:1; 0.15 mg/cm²) was applied uniformly onto the skin of the application site. Application, exposure and removal were done under anaesthesia. After the treatment period of 30 minutes, the application site was rinsed with an aqueous shampoo formulation. During the entire study period, animals wore plastic collars to avoid licking of the treated area.
- Duration and frequency of treatment / exposure:
- Single application. Study duration 48 h (group 8), 72 h (groups 5-7) and 96 h (groups 1-4)
Doses / concentrations
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- Group 4 and 8
- No. of animals per sex per dose / concentration:
- 4 females per group for Mass balance studies (group 4)
5 females (group 8) for Toxicokinetics - Details on dosing and sampling:
- Urine and faeces were collected at the following time intervals (group 4): 0-8, 8-24, 24-48, 48-72 and 72-96 h after administration, and the metabolite profiles were determined by means of HPLC. In the toxicokinetic groups, blood was sampled at 10, 20, 40 min and at 1, 2, 4, 8, 24, 48 and 72 hours after dosing.
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- 5 % (equal to 8 µg/cm²) of the administered dose for dermal application
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The absorption after dermal application was slower compared to oral application, but still relatively fast, as the maximum blood levels were noted after 1 h.
- Details on excretion:
- The most important route of excretion of 14C- HYDROXYETHYL-3,4-METHYLENE-DIOXY-ANILINE HCL and its metabolites for all routes of administration was the urine. Excretion via faeces was significantly less important in all groups. Since the observed proportion of the radioactivity excreted through the faeces was similar after i. v. and after oral application, the amount found in the faeces after oral application is considered to represent phase II metabolites of the dye that have been excreted via the bile.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The metabolite profile in the urine samples and faeces extracts was similar between the different dosing routes. Only metabolised HYDROXYETHYL-3,4-METHYLENE-DIOXY¬ANILINE HCL was detected in urine and faeces, thus demonstrating that the test substance is rapid and extensively metabolised in the Wistar Kyoto rat.
Applicant's summary and conclusion
- Conclusions:
- After dermal application the absorbed amount of HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL was very limited, although the test item was applied with a penetration enhancer. Once absorbed, the routes and rates of elimination were similar for all three routes of administration (i.v., oral and dermal). No differences in the metabolite profile between the routes of administration or between gender were observed and no tendency for bio-accumulation was noted in this study.
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