Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 2001-03-05 to 2001-05-24
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Occlusive repeated insult patch study in humans
- GLP compliance:
- yes
- Remarks:
- Good Clinical Practices
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: ambient
Constituent 1
Constituent 2
Constituent 3
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 108 subjects completed the study (113 were enrolled)
- Sex: males (21.2 %) and female (78.8 %)
- Age: 18.6 to 70.6
- Race: Asian (1.8 %), Black (0.9 %), Caucasian (86.7 %), Hispanic (9.7 %), Other (0.9 %)
- Demographic information: none - Clinical history:
- Inclusion criteria:
- individuals free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, would have interfered with the study results
- individuals of any skin type or race providing the skin pigmentation would allow discernment of erythema.
Exclusion criteria:
- individuals with any visible skin disease at the study site which, in the opinion if the investigative personnel, would have interfered with the evaluation
- individuals receiving systemic or topical drugs or medication which, in the opinion if the investigative personnel, would have interfered with the study results
- individuals with psoriasis and/or active atopic dermatitis/eczema
- females who were pregnant, planning a pregnancy or nursing a child
- individuals with a known sensitivity to cosmetics fragrances, skin care products or topical drugs as related to products being evaluated. - Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: non-porous, plastic film adhesive bandage with a 2 cm x 2 cm Webril pad affixed with hypo-allergenic tape (Micropore) as needed.
- Vehicle / solvent: diethyl phtalate
- Concentrations: 20 %
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: 9 consecutive applications, 48-hour intervals (72-hour if weekend)
Rest period: 10-15 days
Challenge phase: during the 6th week of the study
- Removal of patches: approximately 24 hours after each application
- Other: patches applied to the infrascapular area of the back, either to the right or left of the midline
EXAMINATIONS
During induction sites were evaluated at 48-hour intervals (72-hour if weekend). After challenge, evaluations were done after 48 and 72 hours.
- Grading/Scoring system:
- = No reaction
? = Minimal or doubtful response, slightly different from surrounding normal skin
+ = Definite erythema. No oedema
++ = Definite erythema. Definite oedema.
+++ = Definite erythema. Definite oedema and vesiculation.
- Statistical analysis: none
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: none
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 108
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study, ST 04 C 91 is not a skin sensitiser at 20% in diethyl phtalate. The NESIL /NOAEL is determined to be 2.3 µg/cm².
- Executive summary:
A panel of 108 male and female human volunteers participated in a repeat insult patch test in which a 20% solution of ST 04 C 91 in Diethyl phthalate applied to the back of the subjects under occlusive patches. During the induction phase nine patch were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 14-day rest period, a challenge patch was applied and the sites scored 48 and 72 hours after application.
Under the conditions employed in this study, there was no evidence of sensitisation to ST 04 C 91 at 20%.
A No Expected Sensitisation Induction level (NESIL) or NOAEL can be derived from this study as follows:
Single 0.2 mL 20% test material induction dose (relative density = 0.938) <=>0.00938 mg
Area of exposure: 2 cm x 2 cm = 4 cm²
NESIL or NOAEL = applied dose / area of exposure = 0.00938 / 4 = 0.0023 mg/cm²= 2.3 µg/cm²
The NESIL / NOAEL is determined to be 2.3 µg/cm².
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.