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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
- Study period:
- 11 April 2016 - 28 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-Propanol, 2-methyl-, reaction products with 1,5-diisocyanatopentane
- Cas Number:
- 1357171-37-9
- Molecular formula:
- not applicable (a generic formula cannot be provided for this UVCB substance)
- IUPAC Name:
- 1-Propanol, 2-methyl-, reaction products with 1,5-diisocyanatopentane
- Test material form:
- liquid
- Details on test material:
- - Physical appearance: colourless or light yellow liquid
- Storage conditions: at room temperature, in air-tight containers filled with nitrogen and protected from light
Constituent 1
- Specific details on test material used for the study:
- The test item was used as it was received from the sponsor. Since 1 mL of the test item weighed 1.20 g, the conversion factor (weight/volume) was set at 0.83.
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 210-222 g
- Fasting period before study: overnight (approx. 18 hours)
- Housing: in groups of 3 animals in plastic cages with bedding.
- Diet: CR-LPF pelleted diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 23 ±3 (actual: 23-25°C)
- Humidity (%): 50 ±20 (actual: 44-47%)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 April 2016 To: 11 May 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.66 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: it was expected that the acute oral toxicity of the test item was low and therefore the starting dose level was set at 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 for the first dose step and 3 for the second dose step (females only)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* clinical observations: 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after administration and once daily thereafter for 14 days.
* body weight: day 0 (pre-administration), 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other: external appearance and organs/tissues in the cranial, thoracic and abdominal cavities were examined macroscopically.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred in any animal in the first and the second dosing step.
- Clinical signs:
- other: No abnormal clinical signs in any animal in the first or second dosing step were observed.
- Gross pathology:
- There were no abnormal findings in external appearance or in organs/tissues in the cranial, thoracic or abdominal cavities in any animal in the first or second dosing step.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study performed in accordance with OECD guideline 423, the LD50 for acute toxicity of D-370N in rats exceeded 2000 mg/kg bw. Based on these results, the test item is not classified according to GHS.
- Executive summary:
An acute oral toxicity study was performed according to OECD guideline 423 and GLP principles to assess the toxic potential of D-370N in female Wistar rats. The test item was applied as such by oral gavage in a stepwise manner, starting with a first dosing step of 2000 mg/kg bw. Based on the results of the first dosing step, a second dosing step was performed with a test item concentration of 2000 mg/kg to confirm the results of the first dosing step. Test groups for both dosing steps consisted of 3 female rats of approximately 8 weeks of age. Mortality, clinical signs and body weights were recorded for 14 days after administration. After the observation period, all animals were sacrificed and pathological examination was performed.
No mortality occurred and no abnormal clinical signs were observed in any of the animals in any of the dosing steps. Body weight changes were considered normal. There were no abnormal pathological findings. The LD50 was determined to exceed the highest dose tested (LD50 >2000 mg/kg bw). Based on these results, D-370N is not classified for oral toxicity according to GHS.
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