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EC number: 212-740-3 | CAS number: 865-47-4
- 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:
- two-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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented publication similar to guideline
Data source
Reference
- Reference Type:
- publication
- Title:
- Two-generation Reproduction Toxicity Study with Isopropanol in Rats
- Author:
- C. Bevan
- Year:
- 1 995
- Bibliographic source:
- JOURNAL OF APPLIED TOXICOLOGY, VOL . 15(2), 117-123 (1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- Oestrus cycle and sperm parameters including sperm motility and morphology were not evaluated
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- IUPAC Name:
- propan-2-ol
- Test material form:
- other: colorless liquid
- Details on test material:
- - Name of test material (as cited in study report): Isopropanol
- Physical state: colorless liquid
- Analytical purity: 99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY
- Housing: during mating co-housed, afterwards single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-80°F
- Humidity (%): 18-70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material was administered by gavage as a single daily dose in reverse osmosis water at a volume of 5 ml/kg.
- Details on mating procedure:
- - M/F ratio per cage: 1 male rat was co-housed with 1 female
- Length of cohabitation: 7 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: observation of a copulatory plug or presence of sperm in a vaginal rinse .
- After 7 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: yes, same procedure was repeated after 7 days
- After successful mating each pregnant female was caged (how): single - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses for concentration were performed periodically throughout the study to confirm isopropanol concentrations in dosing solutions.
- Duration of treatment / exposure:
- 10 weeks prior to mating, during mating, gestation, lactation and until the day prior to euthanasia, following weaning of the offspring
- Frequency of treatment:
- once daily
- Details on study schedule:
- Offspring of the P1 generation were designated as F1 generation. At weaning on postnatal day 21 (PND 21), two pups of each sex per litter were selected to become a pool of animals from which the P2 generation would be chosen. The selected P2 populations consisted of 30 neonates of each sex, while the selected P2 of the 1000 mg/kg group consisted of 26 neonates of each sex. They began receiving treatment on PND 21 .
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500 or 1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 rats per sex per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): increased body weight gain in P1 females at 1000 mg/kg bw and P2 females at 500 and 1000 mg/kg bw; no effects on food consumption occurred
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Male mating index was significantly reduced in the P2 generation at 1000 mg/kg.
ORGAN WEIGHTS (PARENTAL ANIMALS): Absolute (abs) and relative (rel) liver weights of P1 male animals treated with 1000 mg/kg were increased. Abs liver weights of P2 males were increased in the 500 mg/kg group, rel. liver weights of the P2 male animals were increased in the 500 and 1000 mg/kg groups. Rel. kidney weights were increased in P2 males receiving 1000 mg/kg. Abs. liver weights of the P2 females were increased in the 1000 mg/kg group, whereas rel. liver weights were increased in P1 and P2 females receiving 500 and 1000 mg/kg. Rel. kidney weights were increased in the P1 and P2 female animals dosed with 1000 mg/kg.
GROSS PATHOLOGY (PARENTAL ANIMALS): no treatment-related finding were observed
HISTOPATHOLOGY (PARENTAL ANIMALS): Kidney effects at the mid- and high-dose group of male animals were characterized by an increased number of hyaline droplets in epithelial cells of the proxima convoluted tubules, increased incidence and severity of epithelial degeneration and hyperplasia, increase incidence of proteinaceous casts in the renal tubules and increased incidence of focal interstitial mononuclear cell infiltration.
Regarding liver effects centrilobular hepatocyte hypertrophy was observed in six of 26 P2 male animals dosed with 1000 mg/kg (P<0 .01).
OTHER FINDINGS (PARENTAL ANIMALS): No treatment-related microscopic changes could be observed in the reproductive tissues, liver, kidneys or tissues with gross abnormalities at post-mortem examination.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decreased male mating index
Results: F1 generation
Details on results (F1)
CLINICAL SIGNS (OFFSPRING): no effects were observed
BODY WEIGHT (OFFSPRING): were significantly decreased during the first 4 days in the highest dose group
GROSS PATHOLOGY (OFFSPRING): no treatment related findings
HISTOPATHOLOGY (OFFSPRING):
OTHER FINDINGS (OFFSPRING): no treatment-related abnormalities could be detected, milk was present in the stomach
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reduced body weight and reduced survival during the first 4 days
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: decreased body weight and decreased survival during the first 7 days
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Increased female liver weights in the absence of histopathological findings were considered to be adaptive changes in response to increased metabolism. The kidney effects noted in the treated male rats are characteristic of hyaline droplet nephropathy, also known as a2u-globulin nephropathy and are not considered to be relevant for human beings.
Applicant's summary and conclusion
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