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EC number: 230-745-9 | CAS number: 7300-34-7
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,3'-[butane-1,4-diylbis(oxy)]bispropanamine
- EC Number:
- 230-745-9
- EC Name:
- 3,3'-[butane-1,4-diylbis(oxy)]bispropanamine
- Cas Number:
- 7300-34-7
- Molecular formula:
- C10H24N2O2
- IUPAC Name:
- 3-[4-(3-aminopropoxy)butoxy]propan-1-amine
Constituent 1
- Specific details on test material used for the study:
- - Purity: 99.7 %
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 200-300 g +/- 20% of the mean weight
- Housing: single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet ad libitumn
- Water (e.g. ad libitum): Tap water ad libitumn per day.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The test item solution was administered to about 50 cm2 (corresponds to at least 10 % of the body surface area) of the previously clipped skin (dorsal and dorsolateral parts of the trunk); following 24 h incubation with the test item, the dressing was removed and the application site rinsed with warm water
- Duration of exposure:
- 24 h
- Doses:
- female: 400, 1000 and 2000 mg/kg
male: 400 and 1000 mg/kg - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- animals were observed for 14 days
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Remarks on result:
- other: no mortality occurred
- Mortality:
- No mortalities occured at any dose level
- Clinical signs:
- other: No systemic signs of toxicity were noted in all animals.
- Gross pathology:
- Local effects observed in the 400, 1000 and 2000 mg/kg dose group comprised very slight to severe erythema, very slight or slight edema, scaling, crust formation, bleeding and eczematous skin changes. Additionally, necrosis was observed in the 2000 mg/kg dose group. Due to severe local effects in the female animals of the 2000 mg/kg dose group no further investigation at this dose level was performed in male animals.
- Other findings:
- Necropsy findings of 4 female animals of the 2000 mg/kg dose group and 1 female animal of the 1000 mg/kg dose group sacrificed at the end of the study comprised several focal skin lesions in the region of the application site, crust formation at the surface and slight focal erythema. No abnormalities were observed in all other animals sacrificed at the end of the study.
The necrotic skin changes in female animals of the 2000 mg/kg dose group assessed by histo-pathological examination indicating full thickness necrosis.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study the acute dermal median lethal dose (LD50) of the test substance was found to be greater than 2000 mg/kg bw for female rats and greater than 1000 mg/kg bw for male rats. Due to the severe local effects (necrosis) observed at the dose level of 2000 mg/kg bw in the female rats no higher dose levels were assessed in male rats. However, due to lacking systemic effects the acute dermal median lethal dose (LD50) of the test substance is very likely to be greater than 2000 mg/kg bw also in the male animals.
- Executive summary:
The study was performed to determine the acute dermal median lethal dose (LD50) of the test substance, applied as a solution in doubly distilled water, in Wistar rats.
The study procedure was based on the EEC, OECD and EPA/OPPTS guidelines.
The test material was applied as a solution in doubly distilled water to the clipped epidermis (dorsal and dorsolateral parts of the trunk) and was covered by a semiocclusive dressing for 24 hours. Dose levels of 400 and 1000 mg/kg bw were applied to groups of 5 male and female rats each. 2000 mgkg bw were given to 5 female rats.
No systemic signs of toxicity were noted in all animals.
The expected body weight gain was generally observed in the course of the study, with the exception of 2 female animals of the 2000 mg/kg bw dose group, which showed stagnation of body weight in the first week of observation.
Local effects observed in the 400, 1000 and 2000 mg/kg bw dose group comprised very slight to severe erythema, vry slight edema, scaling, crust formation, bleeding and eczematoid skin change. In the 2000 mg/kg bw dose group additionally necrosis was observed. Due to severe local effects in the female animals of th 2000 mg/kg bw dose group no further investigation at this dose level was performed in male animals.
No mortality occurred.
Necropsy findings of 4 female animals of the 2000 mg/kg bw dose group and 1 female animal of the 1000 mg/kg bw dose group sacrificed at the end of the study comprised several focal skin lesions in the region of the application site, crust formation at the surface and slight focal erythema. No abnormalities were observed in all other animals sacrificed at the end of the study.
The necrotic skin changes in female animals of the 2000 mg/kg bw dose group assessed by histopathological examination indicating full thickness necrosis.
Under the conditions of this study the acue dermal median lethal dose (LD50) of the test substance was found to be greater than 2000 mg/kg bw for female rats and greater than 1000 mg/kg bw for male rats. Due to the severe local effects (necrosis) observed at the dose level of 2000 mg/kg bw in the female rats no higher dose levels were assessed in male rats. However, due to lacking systemic effects the acute dermal median lethal dose (LD50) of the test substance is very likely to be greater than 2000 mg/kg bw also in the male animals.
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