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EC number: 225-007-8 | CAS number: 4605-14-5
- 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
Endpoint summary
Administrative data
Description of key information
oral:
The oral LD50 value of the test substance was determined to be 736 mg/kg bw (1970, reliability 2).
inhalation:
After 8 h exposure to a saturated vapor atmosphere of the test substance no animals died (1970, reliability 2).
dermal:
Based on a weight of evidence-approach (CAS 107 -15 -3, 56 -18 -8, 111 -40 -0, 112 -24 -3, 109 -76 -2) the substance is classified as acute tocix via the dermal route cat. 3.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Aug - 27 Aug 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study protocol is in principle similar to OECD TG 401, limited documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-Test: Animals were treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
- GLP compliance:
- no
- Test type:
- other: BASF-Test
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Gassner rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: young adults
- Weight at study initiation: 142 - 188 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- aqueous emulsion with Traganth
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%, 10%, 8%, 4%, 2% aqueous emulsion with Traganth - Doses:
- 200, 400, 500, 640, 800, 1000, 1250, 1600 mm3/kg bw (corresponding to 184, 386, 460, 588.8, 736, 920, 1150, 1472 mg/kg bw; calculated using the density of 0.92 g/cm³)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs
- Frequency of observations: several times on the day of application and daily thereafter
- Pathologically investigated: heart, lung, liver, kidney, adrenal gland, stomach, intestine, bladder, genitals, trachea, central nervous system, bone marrow, tumor, blood, urine - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 736 mg/kg bw
- Mortality:
- 1472 mg/kg 10/10 m, 10/10 w
1150 mg/kg 4/10 m, 10/10 w
920 mg/kg 4/10 m, 5/10 w
736 mg/kg 1/10 m, 9/10 w
588.8 mg/kg 0/10 m, 0/10 w
460 mg/kg 0/10 m, 2/10 w
386 mg/kg 0/10 m, 0/10 w
184 mg/kg 0/10 m, 0/10 w - Clinical signs:
- 1472 mg/kg bw: No symptoms on the first day of the trial, the following day rough fur, irregular breathing, apathy. Within 24 hours post applicaion, all animals died
1150 - 460 mg/kg : Huddled together about 10 minutes after application, quiet restrained, shock or irregular breathing and semi-closed eyes. The first six animals died within the first 24 hours,
386 - 184 mg/kg: No symptoms on the first day of the trial, but on the second day rough fur and irregular breathing. - Body weight:
- no data
- Gross pathology:
- Sacrificed animals: Frequently strongly dilated stomachs and sagging intestinal tract. Rot.
- Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 736 mg/kg bw
- Quality of whole database:
- Scientifically acceptable study report, comparable to guideline with acceptable restrictions (mostly due to reduced reporting in times before GLP).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Aug - 27 Aug 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study protocol is in principle similar to OECD TG 403, limited documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). 6 rats per sex were exposed to the vapours or aerosol, generated by bubbling 200 L air/h through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 7 days.
- GLP compliance:
- no
- Test type:
- other: inhalation hazard test
- Species:
- rat
- Strain:
- other: Gassner rat
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- saturated vapor atmosphere
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs
- Frequency of observations: several times on the day of application and daily thereafter
- 7 days post exposure animals were sacrificed and underwent necropsy.
- Pathologically investigated: heart, lung, liver, kidney, adrenal gland, stomach, intestine, bladder, genitals, traches, central nervous system, bone marrow, tumor, blood, urine - Sex:
- male/female
- Dose descriptor:
- other: Inhalation Risk Test
- Exp. duration:
- 8 h
- Remarks on result:
- other: no mortality occured
- Mortality:
- No deaths
- Clinical signs:
- other: violent escape attempts, mucosal irritation
- Body weight:
- no evaluable data
- Gross pathology:
- no findings
- Conclusions:
- The inhalation of a highly saturated vapor-air-mixture caused no mortality but clincal signs, after 8 h of exposure.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- orientating information of inhalation toxicity; inhalation exposure duration: 8 hours; extrapolation of an exact LD50 (4h) is not possible
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
oral:
An acute oral toxicicty study in rats is available (1970). The study was conducted according to acceptable scientific principles. The oral LD50 value of the test substance was determined to be 736 mg/kg bw (reliability 2).
inhalation:
After 8 h exposure to a saturated vapor atmosphere of the test substance no animals died (study year: 1970). The study was conducted according to BASF standard (inhalation hazard test) (reliability 2).
dermal:
An acute dermal toxicity study is available (1970). In this dermal toxicity study on rabbits the LD50 of the test substance was determined to be < 200 mg/kg bw (reliability 4). However, there is no specification of test substance identity available. The todays substance specification has changed. Previous purity was approximately 80 to 90%. Todays new technical processes lead to an increased purity of approximately 99.7%. N,N'-Bis(3-aminopropyl)propane-1,3-diamine is a corrosive substance and is classified and labelled as Skin Corrosion Category 1B, H314. The albino rabbit is the preferable laboratory animal for testing of dermal irritation/ corrosivity because it is highly sensitive to irritating/ corrosive effects. Thus, rabbits are not the preferred species for acute dermal toxicity studies with corrosive substances. It is unclear if death of rabbits was due to systemic toxicity following dermal administration, or due to severe local effects (destroyed skin tissue as corrosion response), and in addition, if damage of the skin facilitated increased systemic exposure to the substance. In contrast, the oral LD50 in rats was determined to be 736 mg/kg, indicating that N,N'-Bis(3-aminopropyl)propane-1,3-diamine is of low toxicity after single ingestion. A retrospective analysis of data from acute oral and dermal toxicity testing, performed on pesticide active substances and new chemical entities submitted for the Notification of New Substances Regulations (a total of 240 substances), has demonstrated that there is a relationship between dermal acute toxicity and oral acute toxicity, and there are no significant numbers of compounds that are classified as a potential hazard only via the dermal route (Creton et al. 2010 Acute toxicity testing of chemicals - Opportunities to avoid redundant testing and use alternative approaches. Critical Reviews in Toxicology; 40(1), 50-83). Thus, the availablae study is not used for classification and a weight of evidence approach is used. The following substances have been taken for the weight of evidence approach: CAS 107-15-3 (1,2-Ethanediamine), CAS 111-40-0 (1,2 -Ethanediamine, N1 -(2 -aminoethyl)-), CAS 112 -24 -3 (1,2-Ethanediamine, N1,N2-bis(2-aminoethyl)-), CAS 109-76-2 (1,3-Propanediamine), CAS 56-18-8 (1,3-Propanediamine, N1-(3-aminopropyl)-). With increasing chain length, no significant changes can be seen in acute oral and dermal toxicity.
intraperitoneal:
After intraperitoneal administration, the LD50 of the test substance was determined to be 32,2 mg/kg bw (1970) The study was conducted according to BASF standard.
Justification for classification or non-classification
Based on the available data N,N'-Bis(3-aminopropyl)propane-1,3-diamine needs to be classified as acute toxic via the oral route category 4, and acute toxic via the dermal route category 3 according to Regulation (EC)No 1272/2008 (CLP).
The acute inhalation toxicity study (inhalation hazard test) performed could not be used for classification according to Regulation (EC) No 1272/2008 (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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