Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-476-4 | 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 07 July 2004 to 02 February 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- EC Number:
- 219-145-8
- EC Name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Cas Number:
- 2372-82-9
- Molecular formula:
- C18H41N3
- IUPAC Name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Clear liquid
- Analytical purity: 30.2% (aqueous solution)
- Lot/batch No.: DEGE909567
- Storage condition of test material: At 25 ˚C, in a tightly closed container, protected from heat, direct sunlight and humidity
- Expiry date: February 2005
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Hamburg, Germany; branch facility: LPT Löhndorf
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.37-3.26 kg
- Housing: Individually in breeding cages with wire floor (surface of ca. 0.2 m2)
- Diet: Ssniff K-Z V2323, ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/ 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance preparations were prepared freshly every day. The test substance was suspended in the vehicle to appropriate dose levels.
VEHICLE
- Amount of vehicle (if gavage): 2 mL/kg bw
- Concentration in vehicle: 3, 4.5 and 10 mg/mL - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical determinations of the test substance in aqueous solution and in test substance-carrier were performed.
- Details on mating procedure:
- - Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: Until copulation was ascertained by observation
- Verification of same strain and source of both sexes: Yes
- Proof of pregnancy: Signs of copulation referred to as Day 0 of pregnancy - Duration of treatment / exposure:
- Days 6-28 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- Until Day 29 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 6, 9 and 20 mg/kg bw/day (pure substance)
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 animals per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on the results of a dose-range finding study (NOEL of 7.5 mg/kg bw/day, based on reduced food intake and local intolerance reactions).
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least once daily
- Cage side observations included: Behavioral changes, reaction to treatment or illness. In addition animals were observed for viability early in the morning and in the afternoon.
BODY WEIGHT: Yes
- Time schedule for examinations: Daily, starting at Day 0 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day # 29
- Organs examined: Internal organs - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: Placenta weight was determined. - Fetal examinations:
- - External examinations: Yes, all per litter
- Soft tissue examinations: Yes, all per litter
- Skeletal examinations: Yes, all per litter
- Head examinations: Yes, all per litter - Statistics:
- The following statistical analysis was used:
For numeric values: Bartlett chi-square test, Dunnett test (for homogeneous variances), Student's t-test (for heterogeneous variances).
For the comparison of classification measurements the Fisher's exact test was employed.
Analytical determinations of Lonzabac in aqueous solution and in test item-carrier were performed.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal toxicity was indicated at 20 mg/kg/day by the death of two dams, by marginally reduced body weight and food intake during the last days of pregnancy. At 20 mg/kg/day, the body weight was marginally reduced during the last gestion days. There was a reduction in food consumption at 20 mg/kg/day from gestation Day 16 onwards, which was up to 36% below the control value (p = 0.05).
Necropsy revealed an irritation of the gastrointestinal tract in 5 dams and an increased incidence of resorptions.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 9 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- At 20 mg/kg bw/day there was a marginal increased incidence of resorptions suggesting early embryonic deaths secondary to maternal toxicity.
- No test substance-related influence was detected on the prenatal foetal development. The incidences of foetal malformations, variations and retardations were similar in all groups. Under the conditions of the study no teratogenic effects (as indicated by the incidences of foetal malformations, variations and retardations) were found up to 20 mg/kg bw/day of the test substance.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 9 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 20 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test substance was not considered to be a developmental toxicant. The NOAELs for maternal effects and embryotoxicity was set at 9 mg a.i./kg bw/day and the NOAEL for teratogenicity was set at 20 mg a.i./kg bw/day respectively.
- Executive summary:
A pre-natal developmental toxicity study was conducted to assess the developmental or teratogenic potential of N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine in Himalayan rabbits according to the OECD Guideline 414 and in compliance with GLP.
Groups of 20 pregnant females received the substance by gavage at dose levels of 0, 6, 9 and 20 mg a.i./kg bw/day during Days 6 -28 of gestation. Animals were sacrificed on gestation Day 29.
Maternal toxicity was indicated at 20 mg a.i./kg bw/day by the death of two dams and by marginally reduced body weight and food intake during the last days of pregnancy. Necropsy revealed an irritation of the gastrointestinal tract in 5 dams and an increased incidence of resorptions. Marginal increased incidence of resorptions suggesting early embryonic deaths secondary to maternal toxicity was observed at 20 mg a.i./kg bw/day. No substance-related influence was detected on the pre-natal foetal development. The incidences of foetal malformations, variations and retardations were similar in all groups. As a result, the NOAELs for both maternal and embryotoxicity were set at 9 mg a.i./kg bw/day and the NOAEL for teratogenicity was set at 20 mg a.i./kg bw/day.
Under the conditions of the study, the test substance was not considered to be a developmental toxicant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
