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EC number: 815-966-6 | CAS number: 915972-17-7
- 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 May 20, 2009 to November 5, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: MAFF in Japan, 12-Nousan-No. 8147, 2-1-6
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- GPMT test conducted in 2009 prior to worldwide acceptance of the LLNA.
Test material
- Reference substance name:
- [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate
- EC Number:
- 815-966-6
- Cas Number:
- 915972-17-7
- Molecular formula:
- C33H39NO9
- IUPAC Name:
- [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate
- Test material form:
- solid
- Details on test material:
- - Analytical purity: 96.1 %
- Appearance: Solid yellowish
- Batch: COD-001545
Constituent 1
- Specific details on test material used for the study:
- Lot/Batch no.: 08072
Description: Pale yellow green powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Oh-hara production facility (Shizuoka, Japan) of Japan SLC, Inc.
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: ca. 7 weeks at dosing
- Weight at study initiation: 371 – 479g
- Housing: Groups of 5 animals housed in cages (485 mm in width x 570 mm in depth x 360 mm in height)
- Diet: Certified pellet diet LRC4 (Lot No. 090305; Oriental Yeast Co., Ltd., Tokyo, Japan)
- Water: Tap water, ad libitum
- Acclimation period: 11 days before application
ENVIRONMENTAL CONDITIONS
- Temperature: 21.8 – 22.4°C
- Humidity: 21.8 – 22.4°C
- Air changes (per hr): 10 or more
- Photoperiod: Alternating 12-hour artificial light and dark cycles. light on at 7:00 a.m. and off at 7:00 p.m.).
- IN-LIFE DATES: From 02-Jun-2009 to 26-Jun-2009
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- or a 1:1 w/w mixture of Freunds’ Complete Adjuvant with water
- Concentration / amount:
- 1% (intradermal) and 50% (epicutaneous occlusive)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- or a 1:1 w/w mixture of Freunds’ Complete Adjuvant with water
- Concentration / amount:
- 50%
- Adequacy of challenge:
- other: Maximum practical concentration that could be prepared and dosed topically and did not give rise to irritating effects.
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Yes
Intradermal injections: In 2 guinea pigs, 0.5 and 1%, w/v. test substance was injected; skin responses were assessed approximately 24 hour later
Topical applications: 4 guinea pigs (2 concentrations / animal), 5, 10, 25 and 50%, w/w; reaction sites were assessed for erythema and edema at 24 hours after removal of the patch
Result of range finding tests:
Intradermal injections: Diffuse or patchy erythema (score 1) and/or moderate dispersed erythema (score 2) were observed on the 0.5% and 1% injected skin sites of 2 animals.
Topical applications: No visible change (score 0) were found on the 5 and 50% of the test substance applied skin sites of 2 animals, and on the 10 and 25% of the test substance applied skin sites of 2 animals.
MAIN STUDY
The following 4 groups were set:
Group/ Induction Exposure / Challenge Exposure
A/ Test item/ Test item
B/ None/ Test item
C/ HCA/ HCA
D/ None/ HCA
HCA: α-Hexylcinnamaldehyde (positive control)
A. INDUCTION EXPOSURE
A.1. Intradermal induction (first induction)
- Test group: 1 (A) (20 animals)
- Control groups: 3 (B, C, D) (10/ 10/ 5 animals)
- Site: Shoulder region of each animal was clipped using an electric clipper
- Frequency of applications: 3 pairs of intradermal injections (0.1 mL each)
- Duration: 7 days
- Concentrations: 1%
[1] Emulsion of FCA (Freund’s complete adjuvant) and SPS (sterilized physiological salt solution) at the rate of 1:1 (v/v)
[2] Suspension of the test substance or solution of HCA in liquid paraffin
[3] Emulsion of the test substance in FCA blended with SPS at the rate of 1:1 (v/v) or emulsion of HCA in FCA blended with SPS at the rate of 1:1 (v/v)
The animals in Group B and D were given similar injections without the supplementation of the test substance and HCA.
A.2. Topical induction (Reinduction)
- Exposure period: On Day 7 after the intradermal induction
Pretreated with 0.5 mL of 10% sodium lauryl sulfate (Kanto Chemical Co., Inc.) in white petrolatum by rubbing on Day 6 after the intradermal induction (after clipping on the day before the topical induction).
- Test group: 1 (A) (20 animals)
- Control groups: 3 (B, C, D) (10/ 10/ 5 animals)
- Site: On the day before application, the shoulder region of each animal was clipped again.
- Frequency of applications: Once
- Duration: 48 hours
- Concentrations: 50%
Group A, 0.4 g of the test substance formulation
Group C, 0.4 mL of the HCA formulation
Animals in the Group B and D were treated with the corresponding vehicle used for preparation of the test substance and HCA formulation.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: On Day 14 after the topical induction
- Exposure period: 24 hours
- Test group: 1 (A) (20 animals)
- Control groups: 3 (B, C, D) (10/ 10/ 5 animals)
- Site: 2 cm x 2 cm of the left flank for each animal. In addition, the white petrolatum for Groups A and B or liquid paraffin for Groups C and D was treated on the right flank of each animal.
- Concentrations: 0.2 g of the test substance formulation (50%) in white petrolatum for Groups A and B or 0.2 mL of HCA formulation (10 %) in liquid paraffin for Groups C and D was applied
- Evaluation (hr after challenge): At 24 and 48 hours after the challenge patch removal
- Challenge controls:
- The positive control with alpha-hexylcinnamaldehyde techn. 97.8% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
- Positive control substance(s):
- yes
- Remarks:
- HCA: α-Hexylcinnamaldehyde (positive control)
Results and discussion
- Positive control results:
- Group C:
In the HCA-treated group, 8 of 10 animals exhibited the reaction of score 2 (moderate dispersed erythema), 1 animal exhibited the reaction of score 1 and the remaining 1 animal exhibited the reaction of score 0.
Group D:
On the other hand, all 5 animals in the unsensitized / HCA-challenged group exhibited score 0.
Therefore, the sensitization rate of HCA-treated group was calculated to be 90% (9/10) and the skin sensitization was evaluated to be Classification V (extreme). This was considered to sufficiently assure the reliability of this study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 7 animals with score 1 (diffuse or patchy erythema), 1 animal with score 2 (moderate dispersed erythema)
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- 8 of 10 animals exhibited the reaction of score 2 (moderate dispersed erythema), 1 animal exhibited the reaction of score 1 (diffuse or patchy erythema) and the remaining 1 animal exhibited the reaction of score 0.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- 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
- Key result
- 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
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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