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EC number: 214-946-9 | CAS number: 1222-05-5
- 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:
- 4 March 1984 to 18 April 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A pre-existing in vivo skin sensitization study was available.
Test material
- Reference substance name:
- 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
- EC Number:
- 214-946-9
- EC Name:
- 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
- Cas Number:
- 1222-05-5
- Molecular formula:
- C18H26O
- IUPAC Name:
- 4,6,6,7,8,8-hexamethyl-1H,3H,4H,6H,7H,8H-indeno[5,6-c]pyran
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Albino Dunkin/Hartley guinea pigs bred in Environmental Safety Laboratory
- Weight at study initiation: (weight 316-350 g)
- Diet (e.g. ad libitum): RGP pellets , hay, cabbage
- Water (e.g. ad libitum): ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other:
- Concentration / amount:
- 1) Two 0.1 mL injections of 50% Freund’s Complete Adjuvant (FCA) in 0.9% saline
2) Two 0.1 mL injections of 0.5% Galoxide 50 (equivalent to 0.325% HHCB) in 0.01% DOBS/saline
3) Two 0.1 mL injections of test substance in 0.01 DOBS/saline mixed 50:50 with FCA such that final concentration of test substance was the same as in 2).
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% Galoxide 50 (equivalent to 65% HHCB)
- Day(s)/duration:
- 48 hours (one week after injections)
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Concentration / amount:
- 25% Galaxolide 50 (equivalent to 16.25% HHCB) in vehicle (70% acetone / 30% polyethylene glycol 400 (aceton/PEG400))
- Day(s)/duration:
- 24 hours (14 days after induction)
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Concentration / amount:
- 25% Galaxolide 50 (equivalent to 16.25% HHCB) in vehicle (70% acetone / 30% polyethylene glycol 400 (aceton/PEG400))
- Day(s)/duration:
- 24 hours (7 days after first challenge)
- No. of animals per dose:
- 10 (six male, four female)
- Details on study design:
- RANGE FINDING TESTS:
Several concentrations of the test substance in 0.01% dodecylbenzene sulphonate in 0.9% physiological saline (0.1% DOBS/saline) were injected intradermally to determine a suitable concentration of the test substance for induction of sensitization. Preliminary occluded patch irritation tests were carried out using several concentrations of the test substance in 70% acetone/30% polyethylene glycol (acetone/PEG400) to determine suitable concentrations of a test substance for both induction of sensitisation and for sensitisation challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections:
1) Two 0.1 mL injections of 50% Freund’s Complete Adjuvant (FCA) in 0.9% saline.
2) Two 0.1 mL injections of 0.5% Galoxide 50 (equivalent to 0.325% HHCB) in 0.01% DOBS/saline.
3) Two 0.1 mL injections of test substance in 0.01 DOBS/saline mixed 50:50 with FCA such that final concentration of test substance was the same as in 2).
Occluded patch application:
- No. of exposures: 1
- Exposure period: 48 hours (one week after injections)
- Site: 2x4 cm clipped and shaved area of the dorsal shoulder
- Concentrations: 100% Galoxide
B. CHALLENGE EXPOSURE
- No. of exposures: 3 (occluded patch application)
- Day(s) of challenge: 7 days after induction, 7 and 14 days after first challenge
- Exposure period: 24 hours
- Concentrations: 25% Galoxide
- Evaluation (hr after challenge): at 24 and 48 hours after removal of the patches - Challenge controls:
- Eight animals were treated as controls and received induction and challenge treatments similar to the test pigs minus the test material.
Another four animals were untreated controls for the third challenge only.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Reading:
- other: 3rd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Reading:
- other: 1st, 2nd and 3rd Reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- None
- Reading:
- other: 1st, 2nd and 3rd Reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5-1)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% Galaxolide
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (score 0.5)
Any other information on results incl. tables
At 24 hours, very faint erythema (score 0.5) was found in 2/10 animals at challenge 1, 3/10 animals at challenge 2, and 1/10 at challenge 3. At 48 hours, 3/10, 1/10 and 0/10 had very faint erythema. At challenge at 24 hours, only one animal showed very faint erythema to faint erythema.
Applicant's summary and conclusion
- Interpretation of results:
- other: Substance is not a skin sensitiser in accordance with EU CLP (1272/2008 and its amendments)
- Conclusions:
- The substance is not a skin sensitizer in the guinea pig maximization test (OECD guideline 406).
- Executive summary:
Test item Galaxolide (65% HHCB in DEP) has been subjected to a guinea pig maximization test (OECD TG 406, non-GLP). The used doses of Galaxolide were 0.5% in 0.01% dodecylbenzene sulphonate in 0.9% saline (DOBS/saline) for the intradermal injection, 100% for the induction patch, and 25% in 70% acetone/30% polyethylene glycol 400 (acetone/PEG400) for the challenge patch. These doses were selected based on preliminary irritation tests using 0.1, 0.25, 0.5, 1.0 and 2.0% Galaxolide concentrations for intradermal injections, however the selection criteria were not clear. The actual concentrations of HHCB are 0.325%, 65%, and 16.25%, respectively. Ten (six male, four female) Albino Dunkin/Hartley guinea pigs (weight 316-350g) were tested on a 2cm x 4cm area of skin in the dorsal shoulder area, clipped and shaved free of fur. Induction consisted of a 0.1 ml intradermal injection of 0.325% HHCB in DOBS/saline and 0.1 ml 50% Freund’s Complete Adjuvant in 0.9% saline. This was followed one week later by a 48 hr occluded patch saturated with 65% HHCB. Challenge applications were made 14 days later with a patch with 16.25% HHCB in 70% acetone/30% PEG 400. Two repeat challenges at weekly intervals were conducted. Observations were made after each challenge at 24 and 48 hours. Eight control animals were received induction and challenge treatments similar to the test pigs minus the test material. At challenge 1, in one animal very faint to faint erythema (score 0.5-1) was noted at 24 hours. In all three challenges three or less per group of ten animals showed very faint erythema (score 0.5) at 24 or 48 hours. There was no evidence of sensitization in any of the guinea pigs at any of the three challenge treatments.
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