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EC number: 415-490-5 | CAS number: 141773-73-1 HELVETOLIDE
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1994-04-27 to 1994-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 401 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Program (inspection date: 1992-10-27 / signed on: 1992-012-04)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE
- Molecular formula:
- C17 H32 O3
- IUPAC Name:
- 2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE
- Reference substance name:
- 2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE
- Molecular formula:
- C17 H32 O3
- IUPAC Name:
- 2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE
- Reference substance name:
- 2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE
- Molecular formula:
- C17H32O3
- IUPAC Name:
- 2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE
- Test material form:
- liquid
- Details on test material:
- - Physical state: clear colourless liquid
- Storage condition of test material: in the dark at approximately 4°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- Crl:CD(SD)BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate Kent.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: approximately 100 g
- Fasting period before study: overnight before dosing
- Housing: in groups of 5, by sex, in grid bottomed cages suspended over cardboard lined excreta trays.
- Diet: pelleted diet ad libitum (SQC rat and mouse maintenance No. 1 Expanded, produced by Special Diets Services, Witham, Essex).
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%): 36-62 %
- Air changes (per hr): no data, air conditioned room
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: delivered on 1994-05-22 for the range-finding study and 1994-04-29 from the main study
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
Range-finding test: 25, 50 and 100 mg/mL
main test: 100 mg/mL
DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- Range-finding test: 500, 1000 and 2000 mg/kg bw
Main test: 2000 mg/kg bw - No. of animals per sex per dose:
- Range-finding test: 2 animals/sex/dose
Main test: 5 animals/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: approximately 30 minutes, 1, 2 and 4 hours afters dosing and thereafter for a further 7 days in the range finding study and 14 days in the main study.
Weighing: on the day of dosing, on days 8 and 15.
- Necropsy of survivors performed: yes, including opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs. Abnormal tissues and organs were preserved in buffered formol saline. Necropsy was not performed on range-finding animals. - Statistics:
- none
Results and discussion
- Preliminary study:
- No deaths occurred and no signs of toxicity were exhibited by any animal in any dose group in the range-finding study
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred.
- Clinical signs:
- other: All animals maintained a healthy appearance throughout the 15 day observation period.
- Gross pathology:
- At necropsy, the submandibular lymph nodes were enlarged and the urinary bladder was distended with fluid in one male. The thymus was red and swollen in one female. No abnormalities were detected in the remaining animals.
- Other findings:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 Combined > 2000 mg/kg bw
- Executive summary:
In a limit acute oral toxicity study performed according to the OECD test guideline No. 401 and in compliance with GLP, groups of fasted, 4 -6 weeks old, Crl:CD(SD) rats (5/sex) were administered a single oral dose of ST 06 C 93 diluted in water at 2000 mg/kg bw by gavage. This limit dose was selected based on the absence of mortality and clinical signs in 2 animals/sex/dose (500, 1000 or 2000 mg/kg bw) in the range-finding study.
The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. At necropsy, the submandibular lymph nodes were enlarged and the urinary bladder was distended with fluid in one male. The thymus was red and swollen in one female. No abnormalities were detected in the remaining animals.
Oral LD50 Combined > 2000 mg/kg bw
Under the test conditions, ST 06 C 93 is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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