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EC number: 228-846-8 | CAS number: 6362-80-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 September 2012- 25 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- No analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation. This exception is considered not to affect the purpose or integrity of the study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene
- EC Number:
- 228-846-8
- EC Name:
- 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene
- Cas Number:
- 6362-80-7
- Molecular formula:
- C18H20
- IUPAC Name:
- (4-methyl-4-phenylpent-1-en-2-yl)benzene
- Details on test material:
- - Name of test material (as cited in study report): 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene
- Physical state: clear colourless liquid
- Analytical purity: 95 %
- Lot/batch No.: 2554
- Expiration date of the lot/batch: 28 February 2013
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing:The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary screening test: 100 % and 50 % v/v
Main test: 50 %, 25 % and 10 % v/v - No. of animals per dose:
- Preliminary screening test: 1/ dose
Main test: 4/ dose - Details on study design:
- RANGE FINDING TESTS:
One mouse was humanely killed that was treated with the undiluted test item. Animals in which any adverse effects were noted that were considered to approach the moderate severity limit set forth in the UK Home Office Project Licence, were humanely killed.
Using available information regarding the systemic toxicity/irritancy potential of the test item, a preliminary screening test was performed using mice, 1 mouse per test item concentration. The mice were treated by daily application of 25 μl of the undiluted test item or at a concentration of 50% v/v in acetone/olive oil 4:1, to the dorsal surface of each ear for 3 consecutive days (Days 1, 2, 3). The mice were observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Local skin irritation was scored daily. Any clinical signs of toxicity, if present, were also recorded. The bodyweight of the mouse treated with the test item at a concentration of 50% in acetone/olive oil 4:1 was recorded on Day 1 (prior to dosing) and on Day 6. The bodyweight of the mouse that was humanely killed was recorded on Day 1 (prior to dosing) and immediately prior to termination (Day 4).
Where necessary the thickness of each ear was measured using an Oditest micrometer (Dyer, PA), pre-dose on Day 1, post dose on Day 3 and on Day 6. Any changes in the ear thickness were noted. Mean ear thickness changes were calculated between time periods Days 1 and 3 and Days 1 and 6. A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitisation.
MAIN STUDY
Test Item Administration: Groups of 4 mice were treated with the test item at concentrations of 50%, 25% or 10% v/v in acetone/olive oil 4:1. The preliminary screening test suggested that the test item would produce systemic toxicity and slight skin irritation with the undiluted test item. However the mouse treated at a concentration of 50% v/v in acetone/olive oil 4:1 suggested that the test item would not produce systemic toxicity or excessive local skin irritation at this concentration.
The mice were treated by daily application of 25 μl of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
3H-Methyl Thymidine administration: Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 μl of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 μCi/ml, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 μCi to each mouse. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- At a concentration of 25 % v/v in acetone/olive oil 4:1, the Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the control group was 5.76. Therefore, α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 4.37
- Test group / Remarks:
- 10 % v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Positive result
- Key result
- Parameter:
- SI
- Value:
- 11.71
- Test group / Remarks:
- 25 % v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Positive result
- Key result
- Parameter:
- SI
- Value:
- 20.57
- Test group / Remarks:
- 50 % v/v in acetone/olive oil 4:1.
- Remarks on result:
- other: Positive result
Any other information on results incl. tables
Preliminary Screening Test
Table 1 Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (% v/v) in acetone/ olive oil 4:1 |
Animal number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
100 |
S-1 |
21 |
* |
0 |
0 |
0 |
0 |
0 |
0 |
HLPtK |
* |
* |
50 |
S-2 |
21 |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
K = Animal humanely killed due to the occurrence of clinical signs of toxicity that approached the moderate severity limit set forth in the UK Home Office Project Licence. Animal weighed 19g before death.
H = Hunched posture
L = Lethargic
Pt= Ptosis
*= No data animal dead
Table 2 Local Skin Irritation – Preliminary Screening Test
Concentration (% v/v) in acetone/ olive oil 4:1 |
Animal number |
Local skin irritation |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
Left |
Right |
Left |
Right |
Left |
Right |
Left |
Right |
Left |
Right |
Left |
Right |
||
50 |
S-1 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
1 |
* |
* |
* |
* |
100 |
S-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*= No data animal dead
Table 3 Measurement of Ear Thickness and Mean Ear Thickness Changes – Preliminary Screening Test
Concentration (%) |
Animal number |
Ear thickness measurement (mm) |
|||||
Day 1 |
Day 3 |
Day 6 |
|||||
Pre-dose |
Post-dose |
||||||
Left |
Right |
Left |
Right |
Left |
Right |
||
100 |
S-1 |
0.235 |
0.245 |
0.230 |
0.236 |
* |
* |
Overall mean (mm) |
0.240 |
0.233 |
* |
||||
Overall mean ear thickness change (%) |
na |
-3.125 |
* |
Concentration (% v/v) in acetone/ olive oil 4:1 |
Animal number |
Ear thickness measurement (mm) |
|||||
Day 1 |
Day 3 |
Day 6 |
|||||
Pre-dose |
Post-dose |
||||||
Left |
Right |
Left |
Right |
Left |
Right |
||
50 |
S-2 |
0.240 |
0.235 |
0.250 |
0.245 |
0.255 |
0.235 |
Overall mean (mm) |
0.238 |
0.248 |
0.245 |
||||
Overall mean ear thickness change (%) |
na |
4.211 |
3.158 |
na = Not applicable
*= No data animal dead
The animal treated with the undiluted test item was humanely killed, on Day 4, due to the occurrence of clinical signs of toxicity that approached the moderate severity limit set forth in the UK Home Office Project Licence.
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted in the mouse treated at a concentration of 50% v/v in acetone/olive oil 4:1.
Based on this information the dose levels selected for the main test were 50%, 25% and 10% v/v in acetone/olive oil 4:1.
Main Test
Table 4 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration (% v/v) in acetone/ olive oil 4:1 |
Dpm |
Dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
13828.85 |
1728.61 |
na |
na |
10 |
60472.80 |
7559.10 |
4.37 |
Positive |
25 |
161890.50 |
20236.31 |
11.71 |
Positive |
50 |
284486.40 |
35560.80 |
20.57 |
Positive |
Clinical Observations and Mortality Data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Bodyweight
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The skin sensitisation potential of the test item was assessed according to OECD Guideline 429. The test item was considered to be a sensitiser under the conditions of the test.
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