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EC number: 700-518-3 | CAS number: 38233-76-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Nov 2010 - 11 Feb 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD and EC test Guidelines and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The study report includes a certificate of GLP compliance issued by the MHRA.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (3R,6S,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene; (3S,6R,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene
- EC Number:
- 700-518-3
- Cas Number:
- 38233-76-0
- Molecular formula:
- C14H18
- IUPAC Name:
- (3R,6S,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene; (3S,6R,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene
- Details on test material:
- - Name of test material (as cited in study report): ETD (Chemical name: ETD (Ed-TCD))
- Substance type: organic
- Physical state: Transparent liquid
- Analytical purity: c.a. 100%
- Lot/batch No.: M0901
- Expiration date of the lot/batch: End of December 2011
- Storage condition of test material: In the dark, refrigerated (c.a. 4°C)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: UK
- Age at study initiation: Approximately eight to twelve weeks of age prior to dosing on Day 1
- Weight at study initiation: 17.4 to 22.4 g
- Housing: Animals were housed in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding, additionally Nestlets and a plastic shelter were included for environmental enrichment.
- Diet (e.g. ad libitum): Free access to Rat and Mouse No. 1 Maintenance Diet
- Water (e.g. ad libitum): Potable water taken from the public supply was made freely available
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12hrs light/12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50% v/v in acetone:olive oil (4:1 v/v) and ‘as supplied’
- No. of animals per dose:
- - Preliminary study: 2
- Main study: 4 - Details on study design:
- RANGE FINDING TESTS:
Compound solubility: A vehicle trial performed with ETD showed that it formed a pale clear yellow liquid at 50% v/v in 4:1 v/v acetone:olive oil (AOO)
- Irritation: An assessment of local irritation was performed and an erythema score greater or equal to 3 and/or an increase in ear thickness of greater than 25% at Day 3 or 6 compared with predose was regarded as irritation which precludes the use of that concentration on the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Skin sensitisation: Local Lymph Node Assay
- Criteria used to consider a positive response: A stimulation Index (SI) was determined as the ratio of disintegrations per minute (DPM) between each sample and the control group. The uptake of 3H-Methyl Thymidine by a suspension containing Lymph Node Cells (LNC) was measured in terms of DPM and is a measure of the sensitisation potential of the test substance. The material was considered to be a sensitiser of the SI was greater than 3.
TREATMENT PREPARATION AND ADMINISTRATION: The test substance (25 µL) was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette. Further groups of four mice received the vehicle alone or the positive control substance in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde (HCA), was 11.4 which demonstrates the validity of this study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI (test/control ratios) obtained for 25, 50% v/v and ‘as supplied’ ETD were 5.8, 6.8 and 7.2 respectively. As a SI of 3 or more was recorded for all three of the concentrations tested, ETD was considered to have the potential to cause skin sensitization.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Group no: Concentration: dpm: 3 AOO 3836.85 4 25 % v/v 22335.95 5 50 % v/v 25997.65 6 As supplied 27746.05 7 HCA 25% v/v 43865.85
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- ETD is regarded as a potential skin sensitizer. Due to the nature of the dose response, it was not possible to extrapolate an EC3 value from the lowest two doses, however it can be concluded that the EC3 value is below the lowest concentration tested.
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