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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1994-01-12 to 1994-02-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 406 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspection date: 1992-10-27)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of study performance, the LLNA method was not adopted.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Darley Oaks, Burton-on-Trent, Staffordshire, England.
- Age at study initiation: young
- Weight at study initiation: 250-300 g
- Housing: in groups of 5 in stainless steel cages.
- Diet (e.g. ad libitum): antibiotic free diet ad libitum (SQC, FD1 guinea pig diet with added vitamin C produced by Special Diets Services, Witham, Essex).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days for the animals used for the preliminary study and 19 days for those selected for the main tests.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 °C. On 2 occasions the recorded temperature fell by 1 °C below the protocol specified range. These deviations are considered not to have affected the outcome of the study.
- Humidity (%): 28-66 %. On one occasion the relative humidity was recorded to be less than the minimum specified in the protocol. This deviation is considered not to have affected the outcome of the study.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: light liquid paraffin
- Concentration / amount:
- 25 % / 3 x 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100 %
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100 % and 50% / 24 hours
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 preliminary test animals, 20 test animals, 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal injections: 100%, 50%, 25%, 10%, 5%, and 1% v/v in light liquid paraffin. 1 guinea-pig pre-treated 7 d before with 4 intradermal injections of 1:1 FCA/water. The highest concentration which produced an acceptable localised response at each injection site was 25%.
- Topical induction and challenge: 100%, 50%, 25% and 12.5% v/v in ethanol. 4 guinea-pigs pre-treated with FCA/water as described above. Undiluted test article was found to be non-irritant when applied topically and was therefore selected for the topical induction phase of the main study. Undiluted test article and a 50% v/v concentration of the test article in ethanol were selected for the challenge concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intradermal injections and topical application
- Exposure period: 48h for topical application
- Test groups:
INTRADERMAL: 3 pairs of intradermal injection (0.1 mL) on Day 0 as follows:
- 1/ 50% v/v FCA/distilled water
- 2/ test substance 25% in light liquid paraffin
- 3/ test substance 25% in 50:50 distilled water/FCA
Six days after the intradermal induction, as the undiluted test material was non-irritant, the test area of all test and control animal was treated topically with 0.5 mL of 10 % sodium lauryl sulphate in light liquid paraffin in order to produce irritation.
TOPICAL: 7 days after intradermal injections, the test substance (100%) was applied (patches of Whatman No. 3 filter paper, 4cm x 2cm) and covered with a strip of "Blenderm" surgical tape secured in place and wrapped with "Elastoplast" elastic adhesive bandage (occlusive tape).
- Control group: similarly treated with the exception that the ethanol was topically applied instead of the test substance
- Site: shaved dorsal area between the shoulders
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after the topical induction application, i.e. 21 d after study initiation
- Exposure period: 24 hours
- Test groups: 100% on the anterior aspect of the left flank, 50% v/v in ethanol on the posterior aspect of the left flank. Similarly treated than topical induction (patches 2cm x 2 cm)
- Control group: similarly treated with the exception that the test substance was omitted
- Site: left flanks
- Concentrations: 100% and 50% v/v in ethanol
- Evaluation (hr after challenge): approximately 24 and 48 hours after patch removal. - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- Benzocaine
Results and discussion
- Positive control results:
- Ethyl p amino benzoate (Benzocaine) was used as a positive control as this is known to be a mild to moderate sensitiser. The material was administered as a 1 % concentration in propylene glycol for the intradermal injections and a 4 % concentration in acetone for the topical induction. Challenge was conducted at concentrations of 4 % and 3 % in acetone. This positive control study took place during the period from 1993-07-07 to 1993-07-31.
Three animals in the test group gave positive response to 4 % benzocaine resulting in a response incidence of 30 %. Neither challenge concentration elicited a response in any control animal at any of the observation times during the study. These results confirm that benzocaine is a mild to moderate sensitizer under the conditions of this study and the test system is therefore considered to be validated.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1 (discrete or patchy erythema)
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 4 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, ST 06 C 93 is not classified as a skin sensitiser.
- Executive summary:
In a dermal sensitisation study performed according to the EU test method B.6 and in compliance with GLP, ST 06 C 93 was tested in female Hartley guinea-pigs using the Guinea-Pig Maximisation Test method (20 treated animals + 10 controls).
The preliminary study determined the concentration to be used for the induction and challenge phases of the main study.
ST 06 C 93 diluted in light liquid paraffin at 25% (v/v) was administered by injection for intradermal induction. As the substance was not a skin irritant, 24 hours prior to the topical application, the site was pre-treated with 0.5 mL 10% w/w sodium lauryl sulphate in light liquid paraffin. Topical induction was performed with the test material as supplied, 7 days after intradermal injections. For the challenge, 21 days after study initiation, it was tested at 100% and 50 % v/v in ethanol.
ST 06 C 93 produces evidence of skin sensitisation in one animal at 100 %, resulting in a response incidence of 5 %.
No response was exhibited by any animal of the control group.
The historical positive control, benzocaine, produces evidence of skin sensitisation in three of ten animal at 100 %, resulting in a response incidence of 30 %.These results confirmed that benzocaine is a mild to moderate sensitiser under the conditions of this study and the test system was therefore considered to be validated.
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 sensitisation endpoint.
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