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EC number: 260-686-4 | CAS number: 57345-19-4
- 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:
- 20-MAY-1997 to 22-JUL-1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo guinea pig maximisation test was already available (performed in 1997) and reliable to evaluate the skin sensitization potential and the classification determination.
Test material
- Reference substance name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Reference substance name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Cas Number:
- 220432-47-3
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Lot No.: 007806
Purity: 98.9% (major peak)
Expiry date : 17-APR-1998
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Albino Dunkin Hartley Guinea Pig, HsdPoc: DH, SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- Number of animals for main study / pretest : 15 males/3 males
Age at delivery : 4- 6 weeks
Age at beginning of acclimatization period : 5 -7 weeks
Body weight at pretest start : Pretest groups 339-440 g
Body weight at beginning of acclimatization period : Control and test group 352-428 g
Identification : By unique cage number and corresponding ear tags
Randomization : Randomly selected at time of delivery
Acclimatization : One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretests. Only animals without any visible signs of illness were used for the study.
Conditions : Air-conditioned with 10-15 air changes per hour and continuously monitored environment with a target range for room temperature of 22 ± 3 °C and for relative humidity between 40-70 % (values above 70 % during cleaning process possible). The animals were provided with a 12-hour light, 12-hour dark cycle. Music was played during the light period.
Accommodation : Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
Diet : Pelleted standard Nafag Ecosan 845 25W4, batch nos. 18/97 and 29/97 guinea pig breeding / maintenance diet ("Nafag", Nahr- und Futtermittel AG, CH-9202 Gossau), ad libitum. Results of analyses for contaminants are archived at RCC.
Water : Community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid (approx. 1 g/1) via the drinking water was provided. Results of bacteriological, chemical and contaminant analyses are archived at RCC
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline and Com oil.
- Concentration / amount:
- Amount = 0.1 ml/site :
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5 % with com oil.
3) The test article diluted to 5 % by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. - Day(s)/duration:
- injection peformed on test day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Amount : 0.3 g diluted at 50% in corn oil
- Day(s)/duration:
- 48 hours performed on test day 8
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Amount : 0.2 g of the highest non-irritating concentration of 50 % test substance in corn oil vehicule
- Day(s)/duration:
- The dressings were left in place for 24 hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Indutcion: 6 intradermal applications per animal
Challenge: 2 patches are put in place - Details on study design:
- INDUCTION
- INTRADERMAL INJECTIONS/ PERFORMED ON TEST DAY 1
An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
Test Group;
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5 % with com oil.
3) The test article diluted to 5 % by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Com oil.
3) 1:1 (w/w) mixture of com oil in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- EPIDERMAL APPLICATIONS/ PERFORMED ON TEST DAY 8
On test day 7 and approximately 24 hours prior to the epidermal application the scapular area (approximately 6 x 8 cm) of the animals of the control and test group was clipped, shaved free of hair and the test area was pretreated with a 10 % dilution of Sodium-Lauryl-Sulfate (SLS) in paraffinum perliquidum as no primary irritation had been observed in the pretest. The SLS was massaged into the skin with a glass rod without bandaging. This 10 % concentration of SLS enhances sensitization by provoking a mild inflammatory reaction (Magnusson and Kligman 1970).
On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in com oil) and placed over the injection sites of the test animals. The volume of test article applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for 48 hours. The epidermal application procedure described ensured intensive contact of the test article.
The guinea pigs of the control group were treated as described above with com oil only. The volume applied was approximately 0.3 ml.
Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical grading system according to Draize.
CHALLENGE/ PERFORMED ON TEST DAY 22
The test and control guinea pigs were challenged two weeks after the epidermal induction application. The test and control guinea pigs were treated in the same way.
Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches (2 x 2 cm) of filter paper were saturated with the highest non-irritating concentration of 50 % (left flank) and the vehicle only (com oil applied to the right flank) using the same method as for the epidermal application. The volume of test article applied was approximately 0.2 g and for the vehicle 0.2 ml. The dressings were left in place for 24 hours.
Approximately 21 hours after removal of the dressing the test sites treated with the test article were depilated - Challenge controls:
- See details in the study design field above
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The positive control was performed with Alpha-hexylcinnamaldehyde from 06-01-1997 to 13-02-1997.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % test substance in corn oil vehicule
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test substance in corn oil vehicule
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% Corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% in polyethylene glycol
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Strong sensitizer
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25% in polyethylene glycol
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- strong sensitizer
Any other information on results incl. tables
No positive reactions were observed in the animals either when treated with corn oil alone or when treated with the test article at 50%in corn oil. As there were no deaths during the course of the treatment period no necropsies were performed. No symptoms of systemic toxicity were observed in the animals. The body weight of the animals was within the range of physiological variability known for guinea pigs of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study none of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 50 % in com oil. No skin reactions were observed in the control group.
Therefore, the test article AMBERKETAL applied at a concentration of 50 % in com oil is considered not to be a sensitizer when used under the described test conditions - Executive summary:
In order to assess the cutaneous allergenic potential of AMBERKETAL, the Maximization Test in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6 was carried out in 15 (10 test and 5 control) male Albino guinea pigs.
The intraderrnal induction of sensitization was carried out with a 5% dilution of the test article in com oil and in an emulsion with Freund's Complete Adjuvant (FCA) / physiological · saline. The epicutaneous induction of sensitization was conducted under occlusion with the test article at 50%in com oil. Two weeks after the epicutaneous induction application the challenge was completed by epicutaneous application of the test article at 50%in com oil under occlusive dressing. The animals of the control group were induced with com oil and FCA/physiological saline and challenged similarly to those of the test group. Cutaneous reactions, i.e. erythema and eschar, as well as oedema formation were evaluated at 24 and 48 hoursafterremovalofthedressing.
No toxic symptoms were evident in the guinea pigs of the control or test group. Nodeaths occurred. In this study none of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 50 % in com oil. No skin reactions were observed in the control group.
Therefore, the test article AMBERKETAL applied at a concentration of 50%in com oil is considered not tobea sensitizer when used under the described test conditions
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