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EC number: 205-517-7 | CAS number: 141-98-0
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Propan-2-ol (Isopropyl alcohol) is both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamate . Therefore, Propan-2-ol (Isopropyl alcohol) need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate .
Data source
Reference
- Reference Type:
- publication
- Title:
- Research Triangle Park report № 311C-4557 to CMA
- Author:
- Tyl, R.W., Masten, L.W., Marr, M.C., Myers, C.B., Slauter, R.W., Gardiner, T.H., Strother, D.E., McKee, R.H., and Tyler, T.R.
- Year:
- 1 994
- Bibliographic source:
- Fundam. Appl. Toxicol. 22:139- 151.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- O-isopropyl ethylthiocarbamate
- EC Number:
- 205-517-7
- EC Name:
- O-isopropyl ethylthiocarbamate
- Cas Number:
- 141-98-0
- Molecular formula:
- C6H13NOS
- IUPAC Name:
- N-ethyl(propan-2-yloxy)carbothioamide
- Test material form:
- liquid
- Details on test material:
- IPETC is prepared through reacting ethoxycarbonyl isothiocyanate/ Ethyl isothiocyanatoformate (CAS 16182-04-0) with propan-2-ol/ isopropyl alcohol (CAS Number 67-63-0) and Butan-1-ol/ butyl alcohol (CAS Number 71-36-3).
IPETC/O-isopropyl ethylthiocarbamate contains propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) which are an integral part of the substance.
Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) are both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamate. Therefore, Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate.
EC Name: propan-2-ol
CAS Number :67-63-0
EC Number:200-661-7
CAS Name: isopropyl alcohol
EC Name: Butan-1-ol
CAS Number : 71-36-3
EC Number: 200-751-6
CAS Name: butyl alcohol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC.
- Age at study initiation: Female rats = 10 weeks of age on Gestational Day 0
- Weight at study initiation: 213.6 - 274.6 g on Gestational Day 0
- Housing: Males were housed singly in solid bottom polycarbonate cages (5" x 11 1/2" x 7"), non-mated females were group housed (maximum 3/cage), and mated females were singly housed in solid bottom polycarbonate cages (6" x 19" x 10 1/2") with stainless steel wire lids
- Diet (e.g. ad libitum): #5002 Purina Certified Rodent Chow ad libitum
- Water (e.g. ad libitum): Deionized/filtered tap water ad libitum
- Acclimation period: 7-day quarantine period
ENVIRONMENTAL CONDITIONS
- Temperature: Reported in the study as 72.0 ± 0.5 °F (approximately 22.2 ºC)
- Humidity (%): . Mean relative humidity = 59.0 ± 0.55% with a range of 46.7 - 70.0%
- Photoperiod (hrs dark / hrs light): 12 hours: 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized/distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The concentration of isopropanol in the dosing solutions varied with dose. Dilutions of isopropanol in deionized/distilled water were formulated independently for each concentration and were prepared in a quantity sufficient for the period of dosing.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- An aliquot of each formulation of isopropanol and vehicle was analyzed to verify the concentration of the test compound. Dosing formulations with assayed values of 90-110% of the nominal concentration were considered to be suitable for use in these studies. Personnel, other than the laboratory supervisor and those involved in analysis of dosage formulations for isopropanol concentration, were not informed of the formulation concentrations until all laboratory work had been completed.
For analysis of the dosing formulations, triplicate 0.100 mL samples of the vehicle control solution (deionized/distilled water) and of the dosing formulations were pipetted into separate GC auto-sampler vials each containing 0.80 mL of methanol. An 0.10 mL aliquot of the internal standard solution, 0.493 g of butanol/mL of water was added for each vial. The samples were mixed and analyzed by gas chromatography. Standards encompassing the range of dosing formulation concentrations were prepared in the same way and also analyzed. - Details on mating procedure:
- - Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: Individual females were placed in the home cage of singly housed males (i.e., 1:1)
- Length of cohabitation: Overnight
- Proof of pregnancy: Sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Gestational Days 6 through 15
- Frequency of treatment:
- Single-dose administration
- Duration of test:
- From Feb. 26, 1990 to March 28, 1990
- No. of animals per sex per dose:
- 25 females/group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily on Gestational Day 0-5 (prior to dosing period) and on Gestational Day 16-20 (after dosing period) and twice daily, at dosing and 1-2 hours after dosing, throughout the dosing period (Gestational Day 6 through 15).
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: At sacrifice, the body, liver and uterus of each sperm-positive female were weighed - Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes- Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- Analyses of Variance(ANOVA) and Bartlett’s test for homogeneity of variance. A one-tailed test (i.e., Williams’ Test and/or Dunnett’s Test) was used for all pairwise comparisons except that a two-tailed test was used for maternal body and organ weight parameters, maternal food consumption, fetal body weight, and percent males per litter. Nominal scale measures were analyzed by Chi-Square Test for Independence for differences among treatment groups.
- Indices:
- Not reported
- Historical control data:
- Not reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No pregnant surviving female aborted, delivered early or was removed from study. Two females (8%) died in the 1200 mg/kg bw/day group and one female (4%) died in the 800 mg/kg bw/day group. Maternal body weights were equivalent across all groups and for all timepoints. The statistically reduced maternal weight gain (Gestational Days 0-20) in the 1,200 mg/kg bw/day group was likely due to significantly reduced gravid uterine weights. Corrected maternal weight gain for Gestational Days 0-20 was statistically equivalent across all groups. There were no treatment related clinical signs apparent in maternal animals. Maternal food consumption was statistically equivalent across all groups for all intervals evaluated although a significant downward trend for Gestational Days 6-9 and 6-15 (treatment period) with no significant pairwise comparisons was evident.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
A total of 22-25 litters were evaluated per group. No litter was fully resorbed. All gestational parameters were equivalent across groups, including pre- and post-implantation loss. Fetal body weights/litter were significantly reduced in the 800 and 1,200 mg/kg bw/day groups. There were no treatment-related increased incidences in individual or pooled external, visceral, skeletal or total fetal malformations or variations.
Effect levels (fetuses)
- Basis for effect level:
- other:
- Remarks on result:
- other: Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no adverse maternal or developmental effects at 400 mg/kg. No evidence of increased teratogenicity was observed at any dose tested. Therefore, isopropanol was not teratogenic to CD rats.
Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate and need to be considered in the assessment of IPETC/ O-isopropyl ethylthiocarbamate . - Executive summary:
There were no adverse maternal or developmental effects at 400 mg/kg. No evidence of increased teratogenicity was observed at any dose tested. Therefore, isopropanol was not teratogenic to CD rats.
Propan-2-ol (Isopropyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate and need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate.
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