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EC number: 237-641-2 | CAS number: 13877-91-3
- 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:
- 07 May 2010 to 03 Jun 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- CIT, BP 563, 27005 Evreux, France
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 7-methyl-3-methyleneocta-1,6-diene
- EC Number:
- 204-622-5
- EC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Cas Number:
- 123-35-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 19.4 ± 0.8 g
- Housing: The animals were housed individually in disposable crystal polystyrene cages (22.00 cm x 8.50 cm x 8.00 cm). Each cage contained (except for the 5 hours following the 3H-TdR injections) autoclaved sawdust (SICSA, Alfortville, France).
- Diet: SSNIFF R/M-H pelleted maintenance diet (SSNIFF Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water: tap water (filtered using a 0.22 micron filter) ad libitum
- Acclimation period: at least 5 days before the beginning of the study
- No contaminants are known to be present in the diet, drinking water or sawdust at levels which may be expected to interfere with or prejudice the outcome of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 2.5, 5, 10, 25 and 50% / 25 µL
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- The concentrations selected for the preliminary test were 10, 25, 50 and 100%.
- For 3 consecutive days, the animals received applications of 25 μL of the dosage form preparations to the external surface of both ears (one concentration per ear).
- Measurement of the ear thickness (using a micrometer) was performed each day before treatment and 72 hours after the last application.
- Since the test item was irritant at the concentration of 100% in the preliminary test, the highest tested concentration retained for the main test was 50%.
MAIN STUDY
- During the induction phase, the test item, vehicle or reference item was applied over the ears for 3 consecutive days.
- On day 6, all animals of all groups received a single intravenous injection of 250 μL of 0.9% NaCl containing 20 μCi of 3H-TdR (specific activity of 20 Ci/mmol) via the tail vein.
- Approximately 5 hours later, the animals were killed by cervical dislocation and the auricular lymph nodes were excised. The lymph nodes were pooled for each experimental group. For each experimental group, a single cell suspension of Auricular Lymph Node Cells (ALNC) was prepared by mechanical disaggregation in Petri dishes with the plunger of a syringe.
- The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.
TREATMENT PREPARATION AND ADMINISTRATION:
- On days 1, 2 and 3, a dose-volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
- In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
- No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application.
CLINICAL EXAMINATIONS
- The animals were observed at least once a day during the study for clinical signs, signs of morbidity or mortality.
- In the main test, the animals were weighed individually on the first day of the study (day 1) and on the day of sacrifice (day 6).
- On days 1, 2 and 3 (before each cutaneous application) and on day 6 (after sacrifice), the thickness of the left ear of each animal of the vehicle control and treated groups was measured using a micrometer.
- Any irritation reaction (erythema and edema) was recorded in parallel.
- Any other observation (coloration, presence of residual test item, …) was noted. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The threshold positive value of 3 for the SI was reached in the positive control group. The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.66
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 0.79
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.59
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1.78
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- EC3
- Value:
- > 50
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The stimulation index rose from 0.66 (concentration 2.5%) to 2.59 (concentration 25%). Therefore, the stimulation index was lower than 3 for the test item at any tested concentration.
CLINICAL OBSERVATIONS:
- Neither mortality nor clinical signs were observed during the study.
- No cutaneous reactions and no notable increase in ear thickness were observed at any of the tested concentrations.
BODY WEIGHTS
- The body weight change of treated animals was similar to that of control animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Remarks:
- in accordance with CLP (1272/2008 and its updates)
- Conclusions:
- Under the experimental conditions of this study, the test item did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
The skin sensitisation potential of the test substance has been tested using the Local Lymph Node Assay (LLNA) according to OECD TG 429 and GLP principles. Test concentrations were determined in a preliminary test ( including 10, 25, 50 and 100%). Since the test item was irritant at the concentration of 100%, the highest tested concentration retained for the main test was 50%. The application of the test substance at concentrations of 2.5, 5, 10, 25 and 50% in a vehicle of acetone and olive oil (4:1 v/v) for three consecutive days did not result in an increase in isotope incorporation which was greater than 3-fold. No clinical effects or mortality were observed. Based on the results, the substance was not considered to be a skin sensitizer.
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