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Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar outbred rat / Crl: (WI) WU BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 9 – 10 weeks
- Weight at study initiation: 167 – 177 g
- Fasting period before study: yes, overnight
- Diet: standard laboratory diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL aqueous suspension of the test substance
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Only a single dose level of 300 mg/kg bw of the test substance was examined. Because the test material has been verified as corrosive to skin, any treatment of the animals with standard dose of 2000 mg/kg bw was anticipated to result in extreme pain and distress to the animals. Moreover, the corrosive and surface active effect of the test substance on the gastro-intestinal tract would prevent a meaningful evaluation of the systemic toxic properties - Doses:
- 300 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations of clinical signs within 1 hour and within 4 hours after dosing and subsequently in surviving animals at least once daily throughout an observation period of 14 days; body weight was recorded immediately before dosing on day 0, and of the surviving animals on days 3, 7 and 14 of the study
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- One female was found dead on day 1, 27 hours after dosing, showing sluggishness, encrusted nose, piloerection and a soiled fur prior to its death. No other mortality was observed during the study.
- Clinical signs:
- other: Clinical signs generally observed after dosing consisted of sluggishness, vocalization, encrustated nose and piloerection.
- Body weight:
- other body weight observations
- Remarks:
- Apart from a slight dip in body weight on day 3, the surviving animals gained weight during the 14-day study. The one animal found dead showed body weight lass.
- Gross pathology:
- Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 (rat, female) of the registration substance was determined to be between 300 and 2000 mg a.i/kg bw. According to the criteria laid down in Regulation (EC) No 1272/2008 as well as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations the registration substance is classified for Acute oral toxicity, Category 4.
- Executive summary:
The acute oral toxicity of the registration substance (99.4% a.i.) was tested in female Wistar rats according to EC method B.1 tris (1996) and OECD guideline 423 (2001). Two groups of 3 female rats received 300 mg/kg bw of test substance by gavage. After exposure the animals were observed for clinical signs, mortality, body weight and gross pathology for 14 days.
One female was found dead on day 1, 27 hours after dosing, showing sluggishness, encrusted nose, piloerection and a soiled fur prior to its death. No other mortality was observed during the study.
Clinical signs generally observed after dosing consisted of sluggishness, vocalization, encrustated nose and piloerection.
Over the 14 day study period the surviving animals gained weight, apart from a light reduction in body weight on day 3. The one animal found dead showed body weight loss.
Examination at necropsy of the animals did not reveal distinct treatment-related gross alterations.
Since 5 out of 6 animals survived the 300 mg/kg bw application of the test substance, the LD50 is estimated to be between 300 and 2000 mg/kg bw. A 2000 mg/kg bw dose level was not examined because of the corrosivity of the test material. The LD50 cut-off is 500 mg/kg bw.
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