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EC number: 814-835-0 | CAS number: 1310672-91-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-11-07 to 2012-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Bis-[2-(isopropoxycarbonyloxy)-benzoyl]-peroxide
- Cas Number:
- 1310672-92-4
- Molecular formula:
- C22H20O10
- IUPAC Name:
- Bis-[2-(isopropoxycarbonyloxy)-benzoyl]-peroxide
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- - CAS-No: 1310672-92-4
- Molar mass: 446.41 g/mol
- Molecular formula: C22H22O10
- Appearance: opaque white gel
Constituent 1
- Specific details on test material used for the study:
- Test item 1: CD08479 2.5% gel
Batch No.: 11.01474 (2.5%)
Density: 1.0270 (2.5%)
Appearance/description: Opaque white gel
Storage conditions: Store below 25 °C, do not Freeze or refrigerate
Expiry date: December 02, 2011
Labeling color code: Yellow
Purity:103.5% I.C.
Test item 2: CD08479 5% gel
Batch No.: 11.01475
Density: 1.0340
Appearance/description: Opaque white gel
Storage conditions: Store below 25 °C, do not Freeze or refrigerate
Expiry date: December 02, 2011
Labeling color code: Blue
Purity: 103.6% LC
Test item 3: CD08479 10% gel
Batch No.: 11.01476
Density: 1.0453
Appearance/description: Opaque white gel
Storage conditions: Store below 25 °C, do not Freeze or refrigerate
Expiry date: December 02, 2011
Labeling color code: Red
Purity: 103.2% LC
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JRj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier (Le Genest-St-Isle, France)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 19.1 to 23.6 g
- Housing: Animals were housed individually in Makrolon Type I cages. The cages were covered by a stainless-steel lid. Each cage contained dust-free sawdust.
- Diet (e.g. ad libitum): Ad libitum, standard pelleted complete diet (Diet reference A04C, SAFE, Augy, France), ad libitum
- Water (e.g. ad libitum): Ad libitum, filtered mains drinking water (0.22 μm)
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100 %
See Table 1 under "Any other information on materials and methods incl. tables" - No. of animals per dose:
- 8 females per dose group
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Before allocation, all animals were weighed. At the discretion of the Study Director, animals with abnormalities likely to be prejudicial to the study were excluded from allocation and were replaced by spare animals (if feasible). The required number of animals was allocated to the different dosage groups according to a computerized randomization (CSOR module of Provantis® software) that ensures a similar body weight distribution among group.
TREATMENT PREPARATION AND ADMINISTRATION:
Test item dilutions and positive control preparations
1. Preparation of the 100%, 50% and 25% concentration-series: The three concentration-series were manufactured (under GMP environment), packaged and supplied by the Pharmaceutical Unit, Galderma R &D, Sophia Antipolis, France, to the Toxicological Team before the beginning of the study.
2. Preparation of the positive control formulations: The LLNA positive control formulations were prepared freshly on each day of treatment (i.e., Days 1 to 3) by the toxicological team using the appropriate amount of vehicle to obtain the concentration of (approximately) HCA 25 % in Acetone/olive oil (4:1, v/v).
Test item administration: Topical administration of 25 μL of vehicle, placebo, drug product dilution or positive control solution on the dorsum of both ears
OBSERVATIONS:
1.Morbidity/ Mortality
All animals were observed at least twice daily during both pre-dosing and the study periods for mortality and morbidity. The circumstances of any deaths or moribund sacrifice were recorded.
2. Clinical signs
The animals were regularly observed at least once during the pre-dosing period and then at least once daily throughout the study to detect any behavioral and physical abnormalities. The nature, onset, severity, reversibility and duration of clinical signs were recorded.
3. Cutaneous reactions
Observation of the treatment-area (ear) were performed daily, 6 hours ± 1 hour after treatment and on Day 6 just before intravenous injection of 3[H] MT.
4. Body weights
The body weights were recorded once during the pre-period period, before allocation and on the first day of dosing (before dosing) and Day 6 (before intravenous injection of 3[H] MT).
For preparation of the concentration series and experimental design see Tables 1 and 2 in box "Any other information on materials & methods incl. tables". - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical analysis was performed using the Provantis 7.0 (validated) system. For each group, the mean and standard deviation were calculated.
A statistical evaluation was performed on the incorporation of the 3[H] MT incorporation (DPM values) results. After a log transformation, an ANOVA (homogeneity of means) and a Dunnett test (comparison for each group against the vehicle group) were performed.
Results and discussion
- Positive control results:
- The positive-control substance exceeded (5.69) the stimulation index of 3 confirming the reliability of the test system. See Table 3 in box "Any other information on results incl. tables".
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.51
- Variability:
- SD = 0.34
- Test group / Remarks:
- 2.5% test item
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.57
- Variability:
- SD = 0.41
- Test group / Remarks:
- 5% test item
- Key result
- Parameter:
- SI
- Remarks:
- mean of 8 animals
- Value:
- 0.52
- Variability:
- SD = 0.47
- Test group / Remarks:
- 10% test item
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
For groups 2 to 6, an individual Stimulation Index (SI) was calculated for each animal, as the ratio between the individual DPM of treated animals versus the mean DPM of the vehicle control group (group 1). Then for each of the groups 2 to 6, a mean SI was calculated.
Stimulation Index (mean) of 0.51, 0.57 and 0.52 was calculated in response to CD08479 2.5%, 5% and 10% formulated in gel, respectively.
Stimulation Index (mean) of 0.25 was calculated for the placebo group (group 2), statistically significant when compared to group 1 (negative control group) following Dunnett’s test.
Stimulation Index (mean) of 5.69 was calculated for the positive control group (HCA 25%), statistically significant when compared to group 1 (negative control group) following Dunnett’s test, which demonstrated the performance and the reliability of the assay (SI ≥ 3).
CLINICAL OBSERVATIONS:
No abnormal clinical signs were observed in any treated-groups during the in-life part of this study.
CUTANEOUS REACTIONS:
No cutaneous reaction (erythema or edema) was observed in groups 1 to 5.
In group 6, treated with positive control HCA at 25%, discrete erythema was observed on Days 1 to 3 in 5/8 females, on Days 2 and 3 in 2/8 females and discrete to slight erythema was observed on Days 1 to 3 in 1/8 female. On Day 6, these reactions were no longer visible.
EAR SWELLING MEASUREMENT:
There was no increase of ear thickness observed between Day 1 (before treatment) and Day 6 (before intravenous injection of 3[H] MT) for any group
BODY WEIGHTS
No effect on the body weight was observed in any treated-group.
Any other information on results incl. tables
Chemical analyses
Analytical controls of CD08479 2.5%, 5% and 10% formulated in gel indicated that homogeneity and target concentrations were attained, within target ranges (100.00 ±10%; analytical method for active ingredient assay Reference RDS.03.ATP.03616.R01), and that the pharmaceutical dosage forms were stable for at least 3 weeks, covering the study duration.
Table 3: Results on Simulation Index
|
Concentration of test item in applied formulation (%) |
Positive control HCA |
|||
Placebo |
2.5 |
5 |
10 |
25% |
|
Group number |
2 |
3 |
4 |
5 |
6 |
N=number of date available |
7 |
8 |
6 |
7 |
6 |
LLNA Concentration series (%) |
NA |
25 |
50 |
100 |
NA |
SI (Mean) |
0.25 |
0.51* |
0.57 |
0.52 |
5.69* |
Standard deviation |
0.08 |
0.34 |
0.41 |
0.47 |
5.10 |
*: statistically significant when compared to vehicle group (5% significant level).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of this study, the test item CD08479 formulated in gel is not considered to be a skin sensitiser
- Executive summary:
In a dermal sensitization study conducted according to OECD 429 with the test item CD08479 formulated in gel and dissolved in AOO (4:1 (v/v) acetone/olive oil, young adult female CBA/JRj mice (8 per dose group) were treated CD08479 2.5%, 5% and 10% gel or Hexyl Cinnamic Aldehyde (HCA, 25% in AOO; positive control) at a constant dosing volume of 25μL on the dorsum of each ear, for three consecutive days. Simulation index along with other parameters including morbidity and mortality, clinical signs, cutaneous reactions, ear swelling and body weight were evaluated. During the study, no mortality or abnormal effects were observed on the female mice. However, discrete to slight erythema were observed on Days 1 to 3 for animals of positive control group (HCA). Stimulation Index of 0.51, 0.57 and 0.52 was calculated in response to CD08479 2.5%, 5% and 10% formulated in gel, respectively.
Based on these results, the test item did not show any potential for skin sensitization up to the concentration of 10% and thus is categorized as a non-skin sensitizer under UN GHS Criteria.
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