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EC number: 200-860-9 | CAS number: 75-31-0
- 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:
- comparable to guideline study
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
- Test material form:
- liquid
- 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
- 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 mated females per group
- Control animals:
- yes
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
- Indices:
- not calculated
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs of rales, labored breathing and vaginal discharge (one female) were uniquely observed in the high exposure level maternal animals. Sneezing was observed in both the high and mid exposure groups with higher incidence in the high exposure group. Fur staining/encrustation/nasal discharge was obsened at a higher incidence in the high exposure group maternal animals than the other exposure groups or the control group. During exposure, clear nasal discharge was observed in the high exposure group and sneezing was observed in the high exposure group
Low incidence of nasal discharge and sneezing were observed in the mid dose group. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- High exposure level: Mean maternal body weights were significantly lower than control values (about 14% lower on gestation day 20) and body weight loss or lower weight gains were observed for the periods of gestation days 6-10, 10-13, 13-16 and 6-20.
Mid exposure level: Reduced body weight gain for gestation days 6-10 and the overall period of gestation days 6-20. Absolute maternal body weights of mid exposure group animals were not significantly lower than control group values. - Food consumption and compound intake (if feeding study):
- not examined
- 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:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced abdominal fat was observed in 9 high exposure level and 2 mid exposure level animals
Incidental hydronephosis, kidney stones and dilated ureter were observed without relationship to treatment. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Early resorption and consequently postimplantation loss were slightly elevated above control values in the mid exposure
group (mean of l.O/dam vs. 0.6/dam); the difference was not statistically significant at the 5% confidence level with the
Bonferroni inequality. Early resorption for the high and low exposure groups were not statistically different from the control
value - Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
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
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: unspecific signs of toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One malformation finding, bent limb bones, was observed in a single fetus in the high exposure group and eight fetuses from this litter exhibited bent rib variation findings. The malformation and variation findings observed in this litter are considered to be the result of factors unique to the dam that were not related to exposure. The fact that the dam of this litter uniquely exhibited a large body weight loss on gestation days 13-16 supports this conclusion. On a litter basis no significant increase in bent rib findings were observed and the increased number of fetuses with bent ribs in the high exposure group because of multiple findings in a single litter is not considered to be evidence for a treatment related effect.
An elevation in reduced 13th rib ossification was observed for the high exposure group, but the difference was not statistically different from the control group with the Bonferroni inequality applied and no supportive treatment related growth retardation findings such as reduced fetal weight or other reduced ossification findings were observed. For these reasons the elevation in reduced 13th rib ossification in the high exposure group was concluded not to be treatment related. - Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 000 mg/m³ air
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, there was no developmental toxicity observable in rats, even at maternal toxic levels
- Executive summary:
Groups of 25 mated female Sprague-Dawley rats were exposed to target isopropylamine concentrations of 50, 500, or 1000 mg/m3 by inhalation, six hours per day, on days 6-15 of gestation. A concurrent control group received house-conditioned air only. Dams were sacrificed on gestation day 20, implantations were described, and fetuses were removed from the uterus. Fetuses underwent a gross external examination and were processed for subsequent visceral or skeletal examination. Analytically measured study mean exposure levels and standard deviations were 50 +/- 1, 499 +/- 5 and 1000 +/- 8 mg/m3 for the low, mid and high exposure levels. No spontaneous deaths occurred in any of the exposure groups or the control group. There were clear signs of maternal toxicity at the high exposure level. Mean maternal body weights were significantly lower than control values (about 14% lower on gestation day 20) and body weight loss or lower weight gains were observed for the periods of gestation days 6-10, 10-13, 13-16 and 6-20. Rales, labored breathing and vaginal discharge (one female) were uniquely observed clinical signs in high exposure group females. Treatment related clinical signs of nasal discharge, sneezing and fur staining/encrustation were also observed in high exposure group females. Slight toxicity was observed at the mid exposure level as evidenced by reduced body weight gain for gestation days 6-10 and the overall period of gestation days 6-20. Absolute maternal body weights of mid exposure group animals were not significantly lower than control group values. Low incidence of nasal discharge and sneezing were observed in the mid dose group. There was no apparent maternal toxicity at the low exposure level. The only maternal postmortem findings that were considered treatment related were observations of reduced abdominal fat in 9 high exposure level and 2 mid exposure level animals.There were no clear indications of embryotoxicity or fetotoxicity at any of the exposure levels. Pregnancy rates, numbers of fetuses and preimplantation loss were comparable between all exposure groups and the control group. Increased mean early resorptions/dam above the control value (less than two fold) in the mid exposure group were not considered to be treatment related because of lack of statistical significance with the Bonferroni inequality and lack of a dose response pattern. Fetal weights and sex distributions were comparable between all treatment groups and the control group. Morphological malformation findings were confined to sporadic incidence in a few fetuses and litters. No statistically significant malformation increases or dose response patterns were observed. One malformation finding, bent limb bones, was observed in a single fetus in the high exposure group and eight fetuses from this litter exhibited bent rib variation findings. The malformation and variation findings observed in this litter are considered to be the result of factors unique to the dam that were not related to exposure. The fact that the dam of this litter uniquely exhibited a large body weight loss on gestation days 13-16 supports this conclusion. On a litter basis no significant increase in bent rib findings were observed and the increased number of fetuses with bent ribs in the high exposure group because of multiple findings in a single litter is not considered to be evidence for a treatment related effect. An elevation in reduced 13th rib ossification was observed for the high exposure group, but the difference was not statistically different from the control group with the Bonferroni inequality applied and no supportive treatment related growth retardation findings such as reduced fetal weight or other reduced ossification findings were observed. For these reasons the elevation in reduced 13th rib ossification in the high exposure group was concluded not to be treatment related.
In conclusion, treatment of Sprague-Dawley rats by the inhalation exposure route at mean analytical levels of 50, 499 or 1000 mg/m3 during the period of major organogenesis did not induce embryotoxic, fetotoxic or teratogenic effects, although slight maternal toxicity was observed at the 499 mg/m3 exposure level and substantial maternal toxicity was observed at the 1000 mg/m3 level.
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