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EC number: 815-922-6 | CAS number: 117713-15-2
- 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:
- weight of evidence
- Study period:
- Jan 08 - Apr 14, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-methyl-4'-n-propyl-[1,1-biphenyl]
- EC Number:
- 815-922-6
- Cas Number:
- 117713-15-2
- Molecular formula:
- C16H18
- IUPAC Name:
- 4-methyl-4'-n-propyl-[1,1-biphenyl]
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc Postbus 6174 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight : 18.5 +/- 0.8 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 24-65%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 6
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10, 25, and 50 (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 50% in MEK
Range Finding Exp.
- Concentration used: 25, 50 %
- Irritation:very slight erythema of the ear skin in both animals up to Score 1
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Concentration: 10, 25, and 50%
- Criteria used to consider a positive response: Stimulation index > 3 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
- Positive control results:
- Conc. SI
0%: 1.0
5% 1.68
10% 1.78
25% 8.19
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test Group: 10%
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test Group: 25%
- Key result
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- Test Group: 50%
- Cellular proliferation data / Observations:
-
EC3 CALCULATION
: The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
MORTALITY: No deaths occurred during the study period.
CLINICAL OBSERVATIONS: No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period.
BODY WEIGHTS: The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Any other information on results incl. tables
Calculation of Stimulation Indices per Dose Group
Test item concentration |
Group Calculation |
||
Mean DPM per animal (2 lymph nodes) |
SD |
S.I. |
|
Vehicle Control Group (acetone/olive oil (4+1, v/v)) |
1435.0 |
483.2 |
1.0 |
10 % Test Item in AOO |
2866.0 |
1519.4 |
2.0 |
5 % Test Item in AOO | 2809.0 |
847.3 |
2.0 |
10 % Test Item in AOO | 3750.6 |
1778.8 |
2.6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not found to be a skin sensitiser under the test conditions of this study.
- Executive summary:
Objective
In the study the test item formulated in in acetone/olive oil (4+1, v/v) was assessed for its possible skin sensitising potential.
Study Design
For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50 (w/w). The highest concentration tested was the highest concentration that could technically be achieved.
Results
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 2.0, 2.0, and 2.6 were determined with the test item at concentrations of 10, 25, and 50% in acetone/olive oil (4+1, v/v), respectively.
No statistically significant increase in group mean DPM values was noted in any group treated with the different concentrations of the test item if compared to the vehicle control.
Conclusion
The test item was not found to be a skin sensitiser under the test conditions of this study.
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