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EC number: 237-732-7 | CAS number: 13952-84-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study with well-documented methodology
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- note: not mentioned in ACC IUC5
- Deviations:
- yes
- Remarks:
- Food consumption was not measured, while a deviation from standard reproductive toxicity testing, considered an acceptable deviation.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- Molecular formula:
- C3H9N
- IUPAC Name:
- propan-2-amine
- Details on test material:
- - Name of test material (as cited in study report): Isopropylamine (2-aminopropane)
- Substance type: organic
- Physical state: clear liquid
- Analytical purity: 99.77 %
- Lot/batch No.: LP-606
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- - Age (males): 10 weeks
- Weight at day 0 of gestation (females): 214-282 g
- Weight at day 0 of gestation (males): 317-389 g
- Number of animals: 25 females/group
- Thirty air changes per hour
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- days 6-15 of gestation
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Method: Gas analyser
- Sampling time: at least 5 times/day (treatment); the control was checked for the presence of test material
twice during the study - Details on mating procedure:
- - Mating: 1 female / 1 male
- Day 0 of gestation: presence of vaginal plug - Duration of treatment / exposure:
- - Gestation days 6-15
- Frequency of treatment:
- - Six hours per day
- Duration of test:
- - Twenty days, Cesarean section on gestation day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/m³ air (analytical)
- Dose / conc.:
- 499 mg/m³ air (analytical)
- Dose / conc.:
- 1 000 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 25 females/group
- Control animals:
- yes
- Details on study design:
- rat (Sprague-Dawley)
inhalation: vapour (whole body)
50, 500, 1000 mg/m3 (nominal conc.)
50, 499, and 1000 mg/m3 (analytical conc. (stable and homogeneous (within 4% difference between chamber locations)))
Vehicle: air
Exposure: - Gestation days 6-15 (- Six hours per day)
equivalent or similar to OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Examinations
- Maternal examinations:
- - Mortality: twice daily
- Clinical observations: on gestation days 0 and 6-20 (on treatment days after exposure)
- Body weight gain: gestation days 0, 6, 10, 13, 16 and 20
- Food consumption: not measured
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopy: findings dams recorded
- Microscopy: not performed - Ovaries and uterine content:
- - Examination of uterine content: number of corpora lutea; relative position and number of live and dead foetuses and early and late resorptions
- Fetal examinations:
- - Examination of fetuses: sex; weight; external, visceral (1/2 of each litter) and skeletal (1/2 of each litter) findings
- Statistics:
- - Dunnett's test; Mann-Whitney U test; Fisher's Exact test
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Mortality and day of death: no deaths
- Body weight(gain): decreased at 1000 mg/m3 on gestation days 10, 13, 16 and 20 and during day 6-20;
at 500 mg/m3, lower gains during gestation days 6-10 and overall 6-20
- Number early delivery: 1 female at 500 mg/m3
- Number of resorptions (early/late): at 500 mg/m3: slightly increased (1.0/dam vs 0.6/dam in the control)
- Number of implantations: no differences
- Pre and post implantation loss: Pre-implantation loss no differences; post-implantation loss, at 500 mg/m3
slightly increased (1.0/dam vs 0.6/dam in the control)
- Number of corpora lutea: no differences
- Duration of pregnancy: scheduled sacrifice on gestation day 20
- Gross pathology incidence and severity: at 1000 mg/m3: reduced abdominal fat in 9 females;
at 50 mg/m3: reduced abdominal fat in 2 females
Incidental hydronephosis, kidney stones and dilated ureter were observed without relationship to treatment.
- Organ weight/histopathology: no da
- Clinical signs: at 1000 mg/m3: rales, laboured breathing and vaginal discharge (one female). An increased
incidence of sneezing, fur staining/encrustration and nasal discharge;
at 500 mg/m3: an increased incidence of sneezing
- Number mated/pregnant at 0, 50, 500 and 1000 mg/m3: 25/22, 25/25, 25/24, 25/24
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 500 mg/m³ air
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- 50 mg/m³ air
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- Sex ratio: no differences
- Body weight gain: no differences
- External abnormalities: no treatment-related differences
- Visceral abnormalities: no treatment-related differences
- Skeletal abnormalities: reduced ossification of the 13th rib and bent ribs at the high dose group
without clear evidence of a dose-response (not significant)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 000 mg/m³ air
- 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:
- The following information is taken into account for any hazard / risk assessment:
In the offspring of rats exposed at up to 1000 mg/m³ during gestation days 6-15, no adverse developmental or teratogenic effects were observed after intrauterine exposure to isopropylamine.
Value used for CSA (route: inhalation):
No adverse effect observed NOAEC: 1000 mg/m³ (subacute; rat) - Executive summary:
In a study conducted in a manner quivalent or similar to OECD Guideline 414 (Prenatal Developmental Toxicity Study), groups of 25 female Sprague-Dawley rats were exposed by whole body vapor inhalation to isopropylamine at 50, 500 or 1000 mg/m3on gestation days 6-15 (Kier and Thake, 1988). Embryonal and fetal development was not impaired following inhalation exposure of pregnant rats to high levels of isopropylamine. Maternal toxicity was observed at 1000 mg/m3, based on effects on bodyweight, treatment-related clinical signs (nasal discharge, rales, labored breathing, sneezing and fur staining/encrustation) and macroscopically observed reduced abdominal fat. The NOAEC (maternal) was 500 mg/m3, and the NOAEC (offspring) was 1000 mg/m3.
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