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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 446-220-4 | CAS number: 365411-50-3
- 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:
- 11th June - 18th July 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability 2 is assigned because the method is according to standard HRIPT guidelines and the results are reliable but without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- In a human Repeated Insult Patch test according to a modified Shelanski - Shelanski human patch test method, 102 human subjects (male/female) were treated on the (cleaned) upper back to 4% (w/w) of the test article in EtOH: DEP (1:3) with an occlusive patch for 24 hours (0.2 ml on 3.63 cm2 patch) and 100 subjects finalised the study. This results in an exposure of 2360 ug/cm2 (0.2 g x 1.07 (RD x 1000 x 0.04 (%)/ 3.63). This was repeated 9 times on Monday, Wednesday and Friday during the induction period. Sites were graded for dermal irritation 24 hours after removal of the patches on Tuesday and Thursday and 48 hours after removal on Saturday. After a 2-week rest period challenge patches were applied on untreated test sites for 24 hours. Dermal irritation was evaluated 0, 24 and 48 hours after removal of the patches. An extra assessment was done after 96 hours in case of reactions.
- GLP compliance:
- yes
- Remarks:
- In compliance with good clinical practice
Test material
- Reference substance name:
- -
- EC Number:
- 446-220-4
- EC Name:
- -
- Cas Number:
- 365411-50-3
- Molecular formula:
- C16 H26 O2
- IUPAC Name:
- 7,7,8,9,9-pentamethyl-2H,4H,4aH,5H,6H,7H,8H,9H,9bH-indeno[4,5-d][1,3]dioxine
- Test material form:
- other: test substance supplied in preparation
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- 102 individuals were used and 100 finished the study
- Clinical history:
- No subjects were impanelled if they exibited or had a history of any acute or chronic dermal, medical or physiological condition that could interfere with scoring.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: the 9 repeated insult (occlusive) patch test (9 RIPT)
ADMINISTRATION: INDUCTION PHASE
- Type of application: occlusive patch
- Description of patch: Parke-Davis Readi-Bandage
- Vehicle / solvent: test substance 4.0% in DEP, volatilized at least 30 minutes on the patch prior to application.
- Concentrations: 4.0%
- Volume applied: 0.2 ml
- Aria: 3.63 cm2
- Testing/scoring schedule: rest period after removal: on Tuesday and Thursday: 24h, on Saturday: 48h, on Monday and Wednesday: 24h, on Friday: 48h.
Test site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine application of the test article had been made.
- Removal of test substance: 24 hours after application
- Other: if a subject developed a positive reaction of a 2-level erythema or greater during the induction phase or if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred at the new site, no further applications would be made.
ADMINISTRATION: CHALLENGE PHASE
- Rest period after induction: 10 to 21 days
- Type of application: previously unpatched test site (occlusive)
- Testing/scoring schedule: test site was scored 24 and 48h after application
EXAMINATIONS
- Grading/Scoring system: according to a 6-point scale:
0 = no evidence of any effect
1 = barely perceptible
2 = moderate
3 = marked
4 = severe
accompanying oedema was recorded with an "e"
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- There were 100 subjects who completed the study. All 9 scores during induction and challenge (24, 48 and 72 hours) were tabulated and were zero.
Applicant's summary and conclusion
- Conclusions:
- During inducation and during challenge all 100 subjects scored zero during induction and challenge exposure of 4% test concentration. This means that the substance did not show skin sensitising properties in human volunteers up to 4% (2360 ug/cm2).
- Executive summary:
In a human Repeated Insult Patch test according to a modified Shelanski - Shelanski human patch test method, 102 human subjects (male/female) were treated on the (cleaned) upper back to 4% (w/w) of the test article in EtOH: DEP (1:3) with an occlusive patch for 24 hours (0.2 ml on 3.63 cm2 patch). This application results in an exposure of 2360 ug/cm2 (0.2 g x 1.07 (RD) x 0.04 (fraction test substance) x 1000 (conversion to ug) / 3.63 cm2). This application was repeated 9 times on Monday, Wednesday and Friday during the induction period. Sites were graded for dermal irritation 24 hours after removal of the patches on Tuesday and Thursday and 48 hours after removal on Saturday. After a 2-week rest period challenge patches were applied on untreated test sites for 24 hours. Dermal irritation was evaluated 0, 24 and 48 hours after removal of the patches. Hundred subjects completed the study. Challenge reactions were scored at 24, 48 and 72 hours. During inducation and during challenge all scores were zero. This means that the substance did not show skin sensitising properties in human volunteers up to 4% (2360 ug/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.