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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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:
- Multi-generation rat reproduction study with isopropanol
- Author:
- Bevan, C., Tyler, T.R., Gardiner, T.H., Kapp, R.W., Jr., Andrews, L. and Beyer, B.K.
- Year:
- 1 995
- Bibliographic source:
- B.K. Journal of Applied Toxicology, Vol. 15(2) pp. 117- 123 (1995).
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc, Kingston facility, Stone Ridge, New York.
- Age at study initiation: (P) 8 wks; (F1) 8 wks
- Weight at study initiation: (P) Males: 265.5-331.9 g; Females: 175.2-228.4 g; (F1) Males: 265.2-265.4 g; Females: 181.1-181.2 g
- Fasting period before study: None
- Housing: stainless steel and wire mesh cage, individually housed, except during the first week of quarantine, during mating, and during lactation
- Diet (e.g. ad libitum): Purina certified rodent chow ad libitum
- Water (e.g. ad libitum): automatic watering system, ad libitum (Elizabethtown Water Company, Elizabeth, New Jersey)
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24.4°C
- Humidity (%): 40 to 70 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: June 13, 1990 To: April 15, 1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Undiluted test material was thoroughly miscible in carrier (RO water) prior to dispensing. Test material dosing solutions were prepared at 6-15 day intervals, in consideration of laboratory scheduling/ Dosing solutions were aliquoted on or prior to the first scheduled day of dosing. Aliquoted dosing solutions were stored in the Compound Preparation Department refrigerator. Unused portions were returned to the Compound Preparation Lab for disposal.
DIET PREPARATION
not administered in diet
VEHICLE
- Justification for use and choice of vehicle (if other than water): vehicle used was water - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: when pregnant or 7 days had elapsed (then cohabited with a different male)
- Proof of pregnancy: copulatory plug or sperm in vaginal smear referred to as day 0 of pregnancy
- After 7 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: yes 3 attempts
- After successful mating each pregnant female was caged (how): individually - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of isopropyl alchohol dose solutions in reverse osmosis water were analyzed by Gas Chromatography for concentration verification.
- Duration of treatment / exposure:
- All P1 and F1 (P2) male and female animals received test or control material daily for at least 10 weeks prior to mating, throughout the mating period, and until the day prior to euthanasia. Additionally, P1 and F1 (P2) females received test or control material during gestation, lactation, and until the day prior to euthanasia, following weaning of their offspring on day 21 postpartum. F1 neonates prior to selection for mating received test or control material beginning on postnatal day 21.
- Frequency of treatment:
- daily
- Details on study schedule:
- - F1 parental animals not mated until 11 weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were 21 days of age.
- Age at mating of the mated animals in the study: 15 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 30/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: not reported
- Rationale for animal assignment (if not random): random - Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: morning and afternoon
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to selecton, first day of dosing and weekly thereafter until euthanasia (males) or weekly until post partum day 21 (females)
BODY WEIGHT: Yes
- Time schedule for examinations: prior to selecton, first day of dosing and weekly thereafter until euthanasia (males) or weekly until post partum day 21 (females) - Oestrous cyclicity (parental animals):
- not reported
- Sperm parameters (parental animals):
- not reported
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 8 pups/litter (4/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 / F2 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, and physical abnormalities.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals as soon as possible after the last litters in each generation were produced.
- Maternal animals: All surviving animals after the last litter of each generation was weaned.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following organs and tissues were prepared for microscopic examination: liver, kidney, vagina, uterus, ovaries, testes, epididymides, seminal vesicles, prostate, pituitary, liver, and any abnormal tissue - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at 21 days of age.
- These animals were subjected to postmortem examinations macroscopic and microscopic examination
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations - Statistics:
- The following parameters were analyzed statistically for significant differences: mean body weights; mean food consumption; mean organ weights; mean relative organ weights
- Reproductive indices:
- calculated
- Offspring viability indices:
- calculated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Free of any observable abnormalities
1 death in control and 1 death in mid dose group considered to be incidental. 2 deaths in high dose group, cause of death was not determined
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
no significant differences
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
no significant differences
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
no significant differences
ORGAN WEIGHTS (PARENTAL ANIMALS)
Mean absolute and relative liver weights in high dose P1 males were statistically significantly increased compared to controls. In females, relative liver weight was increased in the mid-dose and high-dose groups and relative kidney weight was increased in the high dose group.
GROSS PATHOLOGY (PARENTAL ANIMALS)
no significant effects
HISTOPATHOLOGY (PARENTAL ANIMALS)
no significant effects
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- offspring toxicity
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reduced body weights and increased mortality at 1000 mg/kg bw/day
- Remarks on result:
- other: Generation: F1/F2 (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Increased mortality was observed in high-dose F1 offspring compared with controls from postnatal Days 0 to 2. Several F1 weanlings died or were euthanized prior to P2 selection; 1 each in the low- and mid-dose groups, and 18 in the high-dose group.
CLINICAL SIGNS (OFFSPRING)
no significant effects
BODY WEIGHT (OFFSPRING)
High dose F1 male body weights were significantly lower on postnatal days 0 and 1 compared to controls.
GROSS PATHOLOGY (OFFSPRING)
No significant effects
HISTOPATHOLOGY (OFFSPRING)
No significant effects
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- parental
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased organ weights at 1000 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed at highest dose
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL-500 mg/kg bw/day. 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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