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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-861-2 | CAS number: 6790-58-5
- 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:
- From September 17 to October 18, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (Adopted in May 1981)
- Deviations:
- yes
- Remarks:
- FCA/saline was used in the 3rd control injection instead of ethanol FCA/saline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (Adopted in March 1984)
- Deviations:
- yes
- Remarks:
- FCA/saline was used in the 3rd control injection instead of ethanol FCA/saline
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was not available at time of testing
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- EC Number:
- 229-861-2
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan
- Cas Number:
- 6790-58-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyl-dodecahydronaphtho[2,1-b]furan
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GoHI; SPF quality (Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4. CH-4414 Füllinsdorf.
- Age at study initiation: M: 7 weeks; F: 8 weeks.
- Weight at study initiation: M: 370-394 g; F: 374-393 g.
- Housing: individually, in Makrolon type-3 cages with standard softwood bedding.
- Diet: pelleted standard Kliba 342, Batch 59/0 guinea-pig breeding / maintenance diet, ad libitum. Not contaminated.
- Water: community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid via the drinking water. Not contaminated.
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12. Music during the light period.
IN-LIFE DATES: From: 1990-09-17 To: 1990-10-28
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Intradermal induction: 5%
Epicutaneous induction: 30%
Epicutaneous challenge: 30, 10 and 3%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- Intradermal induction: 5%
Epicutaneous induction: 30%
Epicutaneous challenge: 30, 10 and 3%
- No. of animals per dose:
- 10/sex/test group, 5/sex/control group
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal injections: 2 animals; concentrations of 5, 3 and 1% in ethanol (0.1 mL/site). Assessment of dermal reactions 24 hours later. The concentration selected for the main study was 5%.
- Epidermal application: 4 animals; concentrations of 30, 10, 3 and 1% in ethanol. Assesment of dermal reactions immediately after patch removal, 24 and 48 hours later. The concentration selected for epidermal application was 30%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal + epicutaneous.
- Test groups:
Intradermal injections: 3 pairs of intradermal injections (0.1 mL/site) made at the border of a 4 x 6 cm area in the clipped region:
1/ FCA 50:50 with physiological saline
2/ Test article, diluted to 5% with ethanol
3/ Test article diluted to 5% by emulsion in a 50:50 mixture of FCA and physiological saline.
Epidermal applications: on day 7, the test area was pre-treated with 10% Sodiul-Lauryl-Sulfate (SLS) in petrolatum oil, because no irritation concentration could be determined in the corresponding pre-test. On day 8, patches of filter paper (2 x 2 cm) were saturated with concentration of 30% test article in ethanol and applied to the clipped and shaved flanks of each animal. The patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. Reactions sites were assessed immediately, 24 and 48 hours after removal of the dressing.
- Control group:
Intradermal injections: 3 pairs of intradermal injections (0.1 mL/site) made at the border of a 4 x 6 cm area in the clipped region:
1/ FCA 50:50 with physiological saline
2/ Ethanol
3/ FCA 50:50 with physiological saline.
Epidermal applications: treated as described above with the omission of test article (ethanol only).
- Site: dorsal skin from the scapular region
B. CHALLENGE EXPOSURE
- No. of exposures: 1, epicutaneous
- Day(s) of challenge: 2 weeks after the epidermal induction application
- Exposure period: 24 hours
- Test groups: patches (2 x 2 cm) of filter paper were saturated with the test article and applied to the left flank using the same method as for the epidermal application.
- Control group: patches (2 x 2 cm) of filter paper were saturated with the vehicle and applied to the right flank using the same method as for the epidermal application.
- Site: left and right flanks
- Concentrations: 0, 3, 10 and 30 %
- Evaluation (hr after challenge): 24, 48 and 72 (0, 24 and 48 after patch removal)
OTHER: Erythema and oedema were assessed using the numerical grading system of Draize. - Challenge controls:
- None
- Positive control substance(s):
- not required
- Remarks:
- a control group (Formaldehyde-solution) is tested twice a year for sensitivity check of the guinea-pig.
Results and discussion
- Positive control results:
- The most recent test was run from April 23 to May 24, 1990. Clear positive results were observed in 7/10 Formaldehydlosung (HCHO) treated animals after the epidermal challenge application.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 73
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- other: a control group (Formaldehyde-solution) is tested twice a year for sensitivity check of the guinea-pig.
Any other information on results incl. tables
No death occurred during the study. No systemic symptoms were observed in the animals. The body weight gain of the animals was not affected during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material did not produce evidence of skin sensitization (delayed contact hypersensitivity).
- Executive summary:
A dermal sensitization study wasperformed according to OECD guideline No. 406 and in compliance with GLPwith the test material diluted in ethanol. Male and female Himalayan spotted guinea-pigs were tested using the Guinea pig maximisation method (20 treated animal per concentration + 10 control animals).
The preliminary study determined the lowest irritant test substance concentration used at induction phases and the highest non-irritant test substance concentration used at challenge.
The test material diluted in ethanol at 5% was administered by injection for intradermal induction. On day 7, as the substance was not a skin irritant, the site was pre-treated with 10% sodium lauryl sulphate in petrolatum-oil. Topical induction was performed with the test material diluted in ethanol at 30 % Day 8. For the challenge, the test material was applied topically at 30, 10 and 3 % in ethanol.
The sensitivity of the guinea-pig was checked every 6 months at RCC with a Formaldehyde-solution, a known sensitizer.
No signs of ill health or toxicity were recorded in any animals during the observation period.
The test material did not produce evidence of skin sensitization (delayed contact hypersensitivity).
Under the test conditions, the test material is not classified according to the annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC
This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.
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.