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EC number: 203-462-3 | CAS number: 107-10-8
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study that is similar to OECD Test Guidelines with acceptable deviations.
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 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- yes
- Remarks:
- (1) No information on male pre-mating exposure regimen (needs to be 70 days in rats) (2) No information on termination of male rats
- Principles of method if other than guideline:
- Toxicity to fertility
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- IUPAC Name:
- propan-2-amine
- Details on test material:
- isopropylamine, purity 99.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age: 54 days
- Mean weight at study initiation (females): 183-184 g
- Mean weight at study initiation (males): 273 g
- Number of animals: 25 females/treatment
Administration / exposure
- Route of administration:
- inhalation
- Details on exposure:
- - Groups of 20 male rats were exposed for 10.5 weeks before mating
- Groups of 25 female rats were exposed for 10.5 weeks before mating - Details on mating procedure:
- - 1:1 until copulation or up to 7 days (if no mating occurred, the male was replaced once)
- Mating success was determined by presence of copulatory plugs and/or spermatozoa in a vaginal smea
- During mating, exposure continued - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Method: Gas Analyzer/IR
- Sampling times: 5 times/exposure - Duration of treatment / exposure:
- - Exposure period: 12-13 weeks (males)
- Exposure period: 14-15 weeks (females) - Frequency of treatment:
- - Six hours per day, 5 days per week
- Details on study schedule:
- - Duration of test: up to 15 weeks (males)
- Duration of test: 17-18 weeks (females)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 100, and 499 mg/m3
Basis:
analytical conc.
- Corresponding to nominal concentrations of 21, 109 and 526 mg/m3
- No. of animals per sex per dose:
- - Twenty male rats per treatment
- Twenty-five female rats per treatment - Control animals:
- yes
- Details on study design:
- - Female exposures were terminated 13 days after copulation (presence of vaginal plug or sperm in vaginal smear)
Examinations
- Parental animals: Observations and examinations:
- ADMINISTRATION / EXPOSURE:
- Premating period: 10.5 weeks
- Route of administration: inhalation
- Post exposure period: from day 21 of gestation until day 21 of lactation
- Exposure duration: 6 hours/day, 5 days/week (after mating 7 days/week until day 20 of gestation)
- Preparation of particles: using a Laskin-style nebulizer
- Air changes: 12/hour
STANDARDIZATION OF LITTERS:
- On day 4 of lactation litters were culled to 4 pups/sex
PARAMETERS ASSESSED IN PARENTS:
- Detailed observations and body weight were assessed on a weekly basis
- Mortality/clinical observations: daily during and after exposure
- Body weight females: weekly until mating, thereafter on day 0, 6, 13 and 20 of gestation and on day 0, 4, 7, 14 and 21 of lactation
- Number of live pups at delivery
- After termination, females were examined and the number of implantations and the number of corpora lutea were determined
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross necropsy of dams and pups on day 21 of lactation
- Histopathology on tissues of pups of control and high dose group - Litter observations:
- OFFSPRING:
- Body weight: day 0, 4, 7 and 14 of lactation (litter weight by sex) and on day 21 (individual weights)
- External examination on day 0, 4, 7, 14 and 21 of lactation
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Gross necropsy of dams and pups on day 21 of lactation
- Histopathology on tissues of pups of control and high dose group - Statistics:
- - Dunnett's test, (uncorrected) chi-square test
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
- Distribution: range 1.8-10%
- Stability: range 11-15%
PATERNAL TOXIC EFFECTS BY DOSE LEVEL:
- Two males in the high dose group died (week 1 and first week of mating)
- Males in the high dose group had a significantly lower body weight during the majority of the study
- No significant differences appeared in mating and fertility parameters
- Maternal mortality: none
- Body weight: no treatment related effects
- Clinical signs: incidentally fur discoloration and focal hair loss (not treatment-related)
- Mating success: 23/25, 25/25, 23/25 and 25/25 at 0, 20, 100 and 500 mg/m3, respectively
- Number pregnant per dose level: 21, 19, 17 and 19 at 0, 20, 100 and 500 mg/m3, respectively
- Gestational length: 22-23 days
- Gross pathology incidence and severity: no treatment related effects
- The number of corpora lutea, implantations and resorptions was not affected by treatment
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: - No significant effects on mating or fertility parameters
Results: F1 generation
Details on results (F1)
- Mean litter size (day 0): 14, 13, 14 and 14 at 0, 20, 100 and 500 mg/m3, respectively
- Mean litter size (day 21): 8, 8, 8 and 8 at 0, 20, 100 and 500 mg/m3, respectively
- Sex ratio: no treatment related effects
- Body weight (day 0): 6.3, 6.6, 6.5 and 6.2 g at 0, 20, 100 and 500 mg/m3, respectively
- Body weight (day 21): 55, 58, 57 and 56 g at 0, 20, 100 and 500 mg/m3, respectively
- External abnormalities: none
- Histopathology: no treatment related effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No effects on mating or fertility parameters were observed in Sprague-Dawley rats after exposure to an aerosol of isopropylamine at analytical concentrations up to 499 mg/m^3, resulting in a NOAEL of 499 mg/m^3.
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