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EC number: 229-761-9 | CAS number: 6711-48-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-04-20 - 1999-06-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-aminopropyldimethylamine
- EC Number:
- 203-680-9
- EC Name:
- 3-aminopropyldimethylamine
- Cas Number:
- 109-55-7
- Molecular formula:
- C5H14N2
- IUPAC Name:
- N,N-dimethylpropane-1,3-diamine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 3-Dimethylaminopropylamin
- Analytical purity: 99.8 %
- Lot/batch No.: Mixture from January 27, 1999
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, Biberach/Riss
- Age at study initiation: 89-90 days
- Weight at study initiation: Males: 399.7 (365.8 - 430.9) g; Females: 262.5 (235.6 - 291.5) g
- Housing: individually in type DK 111 stainless steel wire mesh cages.
- Diet: Kliba Iaboratory diet rat/mouse/hamster ad libitum
- Water: tap water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTION: The preparations were prepared twice a week, every 96 hours latest.
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: maximum 2 weeks
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test substance solutions were analyzed by gas chromatography.
- Duration of treatment / exposure:
- males: 28 days
females: 46-56 days - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
10 mg/kg body weight/day: as the expected no observed adverse effect level.
50 mg/kg body weight/day: as the intermediate dose level.
200 mg/kg body weight/day: as the dose level with possible toxic effects.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily. The nesting, littering, and lactation behavior of the dams was generally evaluated in the mornings in connection with the daily clinical inspection of the dams.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes - Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
testis weight, epididymis weight - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals after themating period.
- Maternal animals: All surviving animals after the last litter of each generation was weaned.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Postmortem examinations (offspring):
- All surviving pups, all stillborn pups andthose pups that died before schedule, were examined externally, eviscerated and their organs were assessed macroscopically.
- Statistics:
- DUNNETT-test, FISHER'S EXACT test, WILCOXON-test
- Reproductive indices:
- Fertility index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One high dose male animal showed piloerection on study day 2. Another male animal of this test group had respiratory sounds between days 11-23.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- There were no substance-related mortalities in any of the male and female F0 parental animals in any of the groups.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Lowered mean body weight and impaired body weight gain were observed
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- The food consumption of the high dose F0 male animals was statistically significantly reduced during study weeks 0 - 1 and remained slightly reduced for the whole study period without attaining statistical significance. This was in-line with lowered mean body weight and impaired body weight gain.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- With the exception of the clay colored discoloration of the kidneys of one animal (male, high dose group), all gross lesions could be correlated with a meaningful microscopic finding. Histopathology of testes, epididymides and ovaries did not reveal any treatment related microscopic finding.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive performance:
- effects observed, non-treatment-related
- Description (incidence and severity):
- With the exception of two F0 parental females all mated females of test groups 0 - 3 (0, 10, 50, 200 mg/kg body weight/day) became pregnant. Therefore, the fertility index varied between 90 and 100 %. This difference concerning the female fertility index was regarded to be spontaneous in nature and not associated with the treatment of the animals.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- other: fertility
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
Details on results (F1)
There were no substance-related differences concerning pup viability and mortality.
CLINICAL SIGNS (OFFSPRING)
The F1 pups did not show any clinical signs which could be attributed to the treatment. An unilateral microphthalmia was the only clinical observations which occurred in one high dose pup. However, this finding was considered to be spontaneous in nature in respect to the known historical background data of the rat strain investigated in the present study.
BODY WEIGHT (OFFSPRING)
Mean body weights/body weight gains were not influenced by the test substance administration.
GROSS PATHOLOGY (OFFSPRING)
The macroscopic examination of all pups did not reveal any differences between the test groups neither in the type nor in the number of pup necropsy observations.
OnIy spontaneous findings were seen at necropsy (e.g. post mortem autolysis, dilated renal pelvis and microphthalmia) in a few of the large number of examined F1 pups of all groups including the controls generally without a dose-response relationship.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
Under the conditions of this reproduction/developmental toxicity screening test, the oral administration by gavage of 3-Dimethylaminopropyl- amin had no adverse effects on reproductive performance or fertility of the F0 parental animals of all substance-treated groups. There were no signs of developmental toxicity in the progeny of the F0 parents up to and including the high dose group (200 mg/kg body weight/day).
Signs of general, systemic toxicity in the F0 parental animals were confined to the male rats of the 200 mg/kg body weight/day group. Toxicity was characterized by decreased food consumption.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions the oral administration of DMAPA by gavage to rats had no adverse effects on reproductive performance or fertility of the F0 parenteral animals of all substance-treated groups. Signs of general, systemic toxicity in the F0 parental animals were confined to the male rats of the 200 mg/kg bw/day group. Signs of general, systemic toxicity in the F0 parental animals were confined to the male rats of the 200 mg/kg bw/day group.
NOAEL: reproductive performance and fertility = 200 mg/kg bw/day (male/female)
NOAEL: developmental toxicity = 200 mg/kg bw/day (male/female)
NOAEL: systemic toxicity = 50 mg/kg bw/day (male)
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