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EC number: 214-482-7 | CAS number: 1134-23-2
- 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:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987 November- 1990 February
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 1. Reproduction toxicity: A review of test protocols for pharmaceuticals, agrochemicals, food additives and industrial chemicals according to European, American and japanese guidelines. Inveresk Res. Int. Ltd. Musselburgh 1986
2. Pesticide Assessment Guidelines - Subdivision F. Hazard Evaluation - Human and Domestic Animals - Revised Edition. U.S. Environmentla Protection Agency, Washington, 1984
3. Barlow, S.M., Sullivan, F.M.: Reproductive hazards of industrial chemicals. Acad. Press. London, 1982 - GLP compliance:
- no
Test material
- Reference substance name:
- S-ethyl N-cyclohexylthiocarbamate
- EC Number:
- 214-482-7
- EC Name:
- S-ethyl N-cyclohexylthiocarbamate
- Cas Number:
- 1134-23-2
- Molecular formula:
- C11H21NOS
- IUPAC Name:
- S-ethyl N-cyclohexylthiocarbamate
- Test material form:
- other: granulates
- Details on test material:
- Cikloát technikai batch number FL 439 purity : 97,6%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Temperature and relative humidity in the animal rooms were recorded daily and the records retained. The avarage values were 21+-3 c for temperature and 30-70% for relative humidity.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Three groups of SPF Wistar rats were dosed with cycloate technical dietary route through 3-generation (P0, P1, P2) .
A fourth group (0 mg cycloate /kg) served as vehicle control. - Details on mating procedure:
- AP0, P1 és P2 generációban dóziscsoportonként hím: nőstény = 1:2 arányt biztosítottunk. A vemhesség kezdetét ( 1. nap) natív hüvelykenet mikroszkópos vizsgálatával ellenőriztük. A hím és nőstény állatokat átlagosan 12 napig tartottuk együtt, majd a hímeket elkülönítettük, az anyákat pedig egyedi ketrecekben helyeztük el az ellésig, illetve a szoptatás időtartamára.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The experimental diet Cycloate content was controlled by gas chromatography Packard 419.
- Duration of treatment / exposure:
- 1987 November - 1990 February
1. generation P0 1987 November - 1988 November
2. generation P11988 June -1989 June
3. generation P2 1989 February -1991 February - Frequency of treatment:
- daily
- Details on study schedule:
- A P0 szülői generációt 7 hetes kor után kezdték etetni a kísérleti tápokkal (15 hím és 30 nőstény dóziscsoportonként) . A P1 és P2 szülői generációt 4 hetes korban kezdtük etetni a kísérleti patkánytáppal. 11 héten keresztül mind a hím, mind a nőstény állatok ezt a diétás takarmányt fogyasztották folyamatosan. Az ezt a periódust követő kétszeri pároztatás, vemhesség és szoptatási idő alatt a P1 és P2 generáció hím és nőstény állatai továbbra is az említett takarmányozásban részesültek. a két pároztatás között egyhetes időszakot iktattunk be, ami alatt az állatok a diétás tápot fogyasztották.
A P0 szülői generációt 7 hetes korában kezdtük etetni a kísérleti patkánytáppal. 12 héten keresztül mind a hím, mind a nőstény állatok ezt a diétás takarmányt fogyasztották folyamatosan. Az ezt a periódust követő kétszeri pároztatás, vemhesség és szoptatási idő alatt a P0 generáció hím és nőstény állatai továbbra is az említett takarmányozásban részesültek. A két pároztatás között egyhetes időszakot iktattunkbe, ami alatt az állatok a diétás tápot fogyasztották.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- PO szülő generation: 15 hím és 30 nőstény
P1 generation : 15 hím és 30 nőstény
P2 generation: 15 hím és 27 nőstény
- Dose / conc.:
- 36 mg/kg bw/day (actual dose received)
- Remarks:
- PO szülő generation: 15 hím és 30 nőstény
P1 generation : 15 hím és 29 nőstény
P2 generation: 15 hím és 30 nőstény
- Dose / conc.:
- 68 mg/kg bw/day (actual dose received)
- Remarks:
- PO szülő generation: 15 hím és 30 nőstény
P1 generation : 15 hím és 30 nőstény
P2 generation: 3 hím és 6 nőstény
- Dose / conc.:
- 85 mg/kg bw/day (actual dose received)
- Remarks:
- PO szülő generation: 15 hím és 30 nőstény
- Dose / conc.:
- 108 mg/kg bw/day (actual dose received)
- Remarks:
- P1 generation : 15 hím és 24 nőstény
- Control animals:
- yes
- Details on study design:
- Az elleni készülő P2 nőstényeket naponta megfigyeltük. A 8 feletti egyedszámú almokat 8-ra csökkentettük, kivéve az F3 generáció középső ; 68 mg/kg bw/day dóziscsoportját. Feljegyeztük anyánként az újszülöttek számát, az élve vagy holtan született állatok számát, a szoptatás alatt eltűnt (kannibalizmus) vagy elhalt állatok számát. Az élő utódok testtömegét az 1., 4., 7., 14., 21. és 28. napon megmértük. Figyeltük az utódok viselkedését az elválasztásig. A következő indexet számoltuk: kopulációs, fertilitási, gesztációs, életképességi, laktációs index.
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- Daily clinical observation:
All experimental animals - Oestrous cyclicity (parental animals):
- vaginal smear examination
- Sperm parameters (parental animals):
- not exiamined
- Litter observations:
- It is examined see it in the full report.
- Postmortem examinations (parental animals):
- It is examined see it in the full report.
- Postmortem examinations (offspring):
- It is examined see it in the full report.
- Statistics:
- Az egyes dószicsoportokban számított, mért adatok kontrolltól való eltérésének statisztikai ellenőrzésére a Student-t próbát alkalmazták.
- Reproductive indices:
- kopulációs, fertilitási, gesztációs, életképességi, laktációs index
- Offspring viability indices:
- viability index calculated: number of pups live on day 4 of lactation/ number of live on day 0 of lactation
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- A P0 generációnál nem volt klinikai tünet.
. - Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A nőstény állatok testtömeggyarapodása minden dóziscsoportban szignifikánsan csökkent a kontrollcsoporthoz képest.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Az emlő mirigyes szerkezete megváltozott. A parenchima helyét dózisfüggő mértékben zsírszövet foglalta el.
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 3 anyánál a legmagasabb dóziscsoportban 1,2,6 holtan született utód fordult elő.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 85 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (P0)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- a legmagasabb dóziscsoportban nőstények csökkent mozgásaktivitása és borzolt szőrzet.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1 kontroll nőstény a 4 héten elullt, és 1 nőstény a 36 mg/ kg bw dóziscsoportban elhullott a 2. héten.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Minden hím és nőstény kezelt csoportban dózisfüggő testtömeg gyarapodás csökkenés volt.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- A nőstények májtömege a legmagasabb dóziscsoportban csökkent.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A 36 mg/kg bw csoportban 3 nőstény álllatban magzati reszorpció fordult elő.
A 108 mg/kg bw csoportban 6 nőstény álllatban magzati reszorpció fordult elő. - Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- A 67 mg/kg bw dóziscsoportban 5 nőstény állat esetén tejmirigy involució fordult elő.
A 108 mg/kg bw dóziscsoportban 7 nőstény állat esetén tejmirigy involució fordult elő, és egy-egy esetben pathológiás zsíros infiltráció és félheveny gócos interstitiális gyulladás , valamint egy esetben myometritist tapasztaltak. - Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- vemhesülés csökkent a kezelt csoportokban. Az újszülöttek száma a két magasabb dóziscsoportban jelentősen csökkent.
Effect levels (P1)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 36 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 36 mg/kg bw/day (actual dose received)
- System:
- hepatobiliary
- Organ:
- liver
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Az újszülöttek száma a két magasabb dóziscsoportban jelentősen csökkent.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A 36 és a 68 mg/kg bw csoportban a nőstényeknél csökkent a testtömeg gyarapodás.
A 36 mg/kg bw csoportban a hímeknél csökkent a testtömeg gyarapodás. - Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A 36 és a 68 mg/kg bw csoportban a nőstényeknél a májtömeg csökkent. A 36 mg/kg bw csoportban a hímeknél a májtömeg csökkent.
- Gross pathological findings:
- not specified
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 68 mg/kg bw csoportban az emlő mirigyes állományának involúiója volt jellemző.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- ca. 35 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 35 mg/kg bw/day (actual dose received)
- System:
- hepatobiliary
- Organ:
- liver
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- A 108 mg/kg bw dózisnál minden utód elpusztult.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A 67 és a 108 mg/kg bw dózisban szignifikáns elmaradás volt a kontrollhoz képest.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A 36 mg/kg bw him és a A 36 mg/kg bw és a 68 mg/kg bw nőstény csoportokban szignifikánsan csökkent a májtömeg.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 68 mg/kg bw nőstény csoportokban az emlő mirigyes állományának involúciója jelentkezett.
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 68 mg/kg bw nőstény csoportokban az emlő mirigyes állományának involúciója jelentkezett.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
- Dose descriptor:
- LOAEL
- Generation:
- F2
- Effect level:
- ca. 36 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity (F2)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 36 mg/kg bw/day (actual dose received)
- System:
- hepatobiliary
- Organ:
- liver
- mammary gland
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 35 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Corresponding to the data evaluated from this study the 3-generation reproduction toxicity no observed effect level (NOEL) is 35 mg/kg bw/day.
- Executive summary:
Three groups of SPF Wistar rats were dosed with Cycloate technical dietary route through 3 -generation A fourth group served as vehicle control.
Corresponding to the data evaluated from this study the 3-generation reproduction toxicity no observed effect level (NOEL) is 35 mg/kg animal/day.
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