Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 876-151-9 | CAS number: 2292123-68-1
- 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
Endpoint summary
Administrative data
Description of key information
The skin sensitisation endpoint has been fulfilled using a weight-of-evidence approach based on QSAR calculation, in vitro and in vivo data.
The QSAR calculation results indicated that the substance does not possess chemical structures associated with skin sensitisation and hence a prediction of "not a skin sensitiser" was aligned to this substance.
In an in vitro skin sensitisation test conducted in accordance with OECD Guideline 442E, the results of this study indicates that the substance is not a skin sensitiser under conditions of the test.
In an in vivo skin sensitisation test (LLNA-ELISA type) conducted in accordance with OECD Guideline 442B, the mean SI values for the 3 test concentrations tested where all <3. This indicates that the substance is not a skin sensitiser under conditions of the test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Part of weight-of-evidence approach adapting the information requirements of Annex VII 8.3.1 and 8.3.2. under REACH in accordance with Annex XI Section 1.2. A sequential series of skin sensitisation tests were performed which collectively provide all the information required to satisfy the information endpoint for Annex VII 8.3.1. and 8.3.2 under REACH. Therefore in accordance with Annex XI, 1.2 of the REACH Regulation is no additional testing is scientifically necessary based on a weight-of evidence approach.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin sensitisation: Local Lymph Node Assay: BrdU-ELISA or –FCM)
- Version / remarks:
- Appendix IA, June 25 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Japan
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 8 weeks for pre-screen, 9 weeks for main study
- Weight at study initiation: See Main study Day 1 - Table 3 in results sections
- Housing: polycarbonate cages with wood chips and environmental enrichment
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): chlorinated water, ad libitum
- Acclimation period: 7 days for pre-screen, 14 days for main study
- Indication of any skin lesions: all animals in good health condition
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- dimethylformamide
- Concentration:
- 10%, 25% and 50%
- No. of animals per dose:
- 4 animals per test item concentration
4 animals for vehicle control
4 animals for positive control - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Vehicle solubility trials were performed. Recommended vehicles in the OECD 442, acetone: olive oil (4:1 v/v/ AOO), DMF, methyl ethyl ketone (MEK) and dimethylsulfoxide (DMSO) were selected for solubility trials. The test item dissolved in DMF and DMSO at 50% (v/v), however, after 5 hours test item crystallised in the DMSO. The test item was not soluble on MEK or AOO. and therefore DMF selected as the vehicle for the pre-screen and main study.
- Irritation: none
- Systemic toxicity: none (no abnormalities reported)
- Ear thickness measurements: yes (see Table 2 in the results section)
- Erythema scores: no erythema so not scored
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test item was regarded as a "sensitiser" when the SI of the test item was 2.0 or more and was regarded as "non-sensitiser" when the SI of the test item group was less than 1.6. When the SI was between 1.6 and 1.9, dose-response relationship and statistical significance would be considered.
TREATMENT PREPARATION AND ADMINISTRATION:
The test solution was prepared on each sensitisation day. 0.5 was dissolved in DMF and filled up to make 1mL of 50 w/v% solution. The 50 w/v% solution was serially diluted to prepare the test solutions at 25 and 10 w/v%.
25µL of each formulation was applied to the dorsum of each ear of the animals using a micropipette once per day for 3 consecutive days.
Approx. 48 hours after the final application of the formulations, 0.5 mL of BrdU solution was administrated intraperitoneally to each animal using a syringe and a needle. Approx. 24 hours after the BrdU administration, animals were humanely killed and each auricular lymph node was taken. The lymph nodes were carefully dissected and trimmed of surrounding tissue and fat, weighed both sides together. The mean values and standard deviations of the local lymph node weights were calculated for each group. The lymph nodes were stored individually in a biomedical freezer. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statistic performed as SI values all <1.6.
- Positive control results:
- SI = 2.93 +/-0.24.
The SI value was >2 and therefore indicates that the test system was functioning as intended. - Parameter:
- SI
- Value:
- 1.08
- Variability:
- S.E. +/- 0.12
- Test group / Remarks:
- 10%
- Remarks on result:
- other: Mean SI value
- Parameter:
- SI
- Value:
- 1.18
- Variability:
- S.E. +/- 0.15
- Test group / Remarks:
- 25%
- Remarks on result:
- other: Mean SI value
- Parameter:
- SI
- Value:
- 1.48
- Variability:
- S.E. +/- 0.21
- Test group / Remarks:
- 50%
- Remarks on result:
- other: Mean SI value
- Parameter:
- SI
- Value:
- 2.93
- Variability:
- S.E. +/- 0.24
- Test group / Remarks:
- Positive control
- Remarks on result:
- other: Mean SI value
- Parameter:
- SI
- Value:
- 1
- Variability:
- S.E. +/- 0.04
- Test group / Remarks:
- Vehicle control
- Remarks on result:
- other: Mean SI value
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Lymph node weight - see Table 5
DETAILS ON STIMULATION INDEX CALCULATION
EC3 CALCULATION: not calculated
CLINICAL OBSERVATIONS:
See Table 4
BODY WEIGHTS
See Table 3
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness). None. - Conclusions:
- The SIs of the 50.0, 25.0 and 10.0 w/v% test item groups were 1.48, 1.18 and 1.08 (all SIs less than the cut-off value of 1.6. Therefore under the condition of the test, the test item was judged to be non-sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- other: weight of evidence
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442E (In Vitro Skin Sensitisation assays addressing the key event on activation of dendritic cells on the Adverse Outcome Pathway for skin sensitisation)
- Version / remarks:
- June 25, 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- human Cell Line Activation Test (h-CLAT)
- Details of test system:
- THP-1 cell line [442E]
- Details on the study design:
- PREPARATION OF TEST SOLUTIONS
- Preparation of the test chemical stock solution: Test item was weighed and dissolved in DMSO using a laboratory mixer to prepare the test stock solution
- Preparation of the test chemical serial dilutions: Solutions prepared just for before use, stored at room temperature under yellow light and used within 2 hours. Diluted using DMSO and prepared under yellow light.
- Preparation of the positive controls: The positive control was weighed and dissolved in DMSO using a laboratory mixer to prepare the 100mg/mL solution. This solution was diluted with DMSO to prepare 2.0 mg/mL solution. Solution prepared just for before use, stored at room temperature under yellow light and used within 2 hours.
- Preparation of the solvent, vehicle and negative controls: not specified in detail. Negative control stored in freezer (-10 to -30°C )
- Stable dispersion obtained: yes
DOSE RANGE FINDING ASSAY:
- Highest concentration used: 1000µg/mL (first test); 10µg/mL (second test)
- Solubility in solvents: yes
- Solubility in incubation medium: 62.5µg/mL or more, precipitation was observed (first test); non precipitation observed in test concentration (second test)
- Results of selecting appropriate concentration and determination of cytotoxicity: CV75
- Final concentration range selected on basis of the CV75 results. The highest dose was set at 3.83 µg/mL equivalent to 1.2 times CV75 and 7 doses set based on a geometric progression of 1.2.
APPLICATION OF THE TEST CHEMICAL AND CONTROL SUBSTANCES
- Number of replicates:
- Number of repetitions: 3 mains tests (3 confirmatory test)
- Test chemical concentrations: 1.07, 1.28, 1.54, 1.85. 2.22, 2.66, 3.19 and 3.83 µg/mL (main tests); 1.13, 1.36, 1.63, 1.96, 2.35, 2.82, 3.38, 3.55, 3.73, 3.91 and 4.11 µg/mL
- Application procedure: Each test solution was added to each well which cells were seeded and mixed then incubated. Non-treatment groups - 500µL of the medium was added.
- Exposure time: 24 +/- 0.5 hours
- Study evaluation and decision criteria used: Flow cytometry analysis; calculation of Relative Fluorescence Intensity (RFI). If the RFI of CD86 was 150 or more at any dose with cell viability >/=50%, and/or if the result of the RFI of CD54 was 200 or more at any dose with cell viability >/=50%, the result was considered positive. Otherwise it was judged to be negative.
- Description on study acceptance criteria: In the non-treatment group and the negative control group, it was judged negative for both CD86 and CD54 and cell viabilities were more than 90%. In the positive control group, it was judged positive for both CD86 and CD54 and cell viability was 50% or more. In the non-treatment group and the negative control group, the MFI ratios of both CD86 and CD54 to isotype were greater than 105%.
For the test item group, the cell viabilities were greater than 50% in at least four tested in each main test. When any criterion was not satisfied, the test results was rejected and the re-test of the test was carried out.
SEEDING AND INCUBATION
- Seeding conditions (passage number and seeding density): <30; cell density was not to exceed 1x10E6 cells/mL during passage.
- Incubation conditions: CO2 incubator; 37°C; CO2 concentration 5%; under humid condition
MEASUREMENT OF CELL SURFACE EXPRESSION/LUCIFERASE ACTIVITY
For h-CLAT and USENS
- Flow cytometry used: Flow cytometer (Navios EX, Beckman Coulter)
- Plate used: 96-well round-bottom plate
- Preparation for CD54 and/or CD86 expression measurements/cell staining: the mixture of working solution and cell suspension after treatment were transferred into 2 mL sample tubes. The cell were collected by centrifugation. The supernanants were discarded and the remaining cells were suspended 1 mL of staining buffer. The cells were collected by centrifugation and then washed one with 1mL of staining buffer. The supernanants were discarded and the remaining cells were suspended in 600µL of globulin solution and incubated at 4°C for 15 minutes. Cells were divided into 3 aliquots of 180µL into 96-well round-bottom plate and were collected by centrifugation. The supernanents were discarded and the cells were stained with 50µL of each antibody solution at 4°C for 30 minutes in the dark.
- Propidium iodide staining/cytotoxicity measurements: yes; Cell viability was calculated by measuring a total of 10000 living cells (PI negative). 150µL of staining buffer was added to each well. The cells collected by centrifugation. The supernanants were discarded and remaining cells were suspended with 200µL . Cells collected by centrifugation and then washed one with 200µL of staining buffer. The supernanants were discarded and the remaining cells were suspended with 200µL of staining buffer. The cell suspension were transferred into tubes with 180µL staining buffer. 20µL of PI solution (12.5 µg/mL) was added to each tube (final concentration of PI = 0.625 µg/mL).
DATA EVALUATION
- Cytotoxicity assessment: The cell viability of each treatment group was exhibited by the cell viability when stained with isotype control - Vehicle / solvent control:
- DMSO
- Negative control:
- other: Culture cell medium
- Positive control:
- dinitrochlorobenzene (DNCB) [442E]
- Positive control results:
- The positive control was judged to be positive for both CD86 and CD54 and cell viability was 50% or more.
- Group:
- test chemical
- Run / experiment:
- other: 1st confirmatory test
- Parameter:
- RFI CD54>150 [442E]
- Cell viability:
- four or more doses were 50% or more viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The RFI values were below 150 when the cell viability was 50% or more in each dose.
- Group:
- test chemical
- Run / experiment:
- other: 1st confirmatory test
- Parameter:
- RFI CD86>200 [442E]
- Cell viability:
- four or more doses were 50% or more viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The RFI values were below 200 when the cell viability was 50% or more in each dose.
- Group:
- test chemical
- Run / experiment:
- other: re-run 2nd confirmatory test
- Parameter:
- RFI CD54>150 [442E]
- Cell viability:
- four or more doses were 50% or more viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The RFI values were below 150 when the cell viability was 50% or more in each dose.
- Group:
- test chemical
- Run / experiment:
- other: re-run 2nd confirmatory test
- Parameter:
- RFI CD86>200 [442E]
- Cell viability:
- four or more doses were 50% or more viability
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The RFI values were below 200 when the cell viability was 50% or more in each dose.
- Other effects / acceptance of results:
- 6 experiments were run in total:
- 1st main test - negative - REJECTED
- 2nd main test - positive - REJECTED
- 3rd main test - negative - REJECTED
Negative results obtained in 2 out of 3 main tests. The RFIs of CD54 was 200 or more at 3.83 µg/mL at which the cell viabilities were approx. 30%. No doses had cell viabilities between 50 - 90%. In order to determine whether the RFI of CD54 increases at between 3.19 µg/mL and 3.83 µg/mL, the confirmation test was conducted, rejecting the results of the main tests.
- 1st confirmatory test - Negative - VALID (see Table 1)
- 2nd confirmatory test - REJECTED - RFIs were not dose-related for CD86 and CD54
- re-run 2nd confirmatory test - Negative - VALID (see Table 2) - Conclusions:
- The item item was classified as negative by h-CLAT under the test conditions.
- Endpoint:
- skin sensitisation: in chemico
- Remarks:
- QSAR result
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
QSAR
2. MODEL (incl. version number)
DEREK NEXUS 6.1.0.
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
c1cc(ccc1S(-O)(Oc2cc(ccc2)NC(=O)Nc3cc(ccc3)OS(=O)(c4ccc(cc4)C)=O)=O)C
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.
5. APPLICABILITY DOMAIN
See attached QMRF.
6. ADEQUACY OF THE RESULT
The result is to be used as part of a weight-of-evidence approach to fulfil the skin sensitisation endpoint with other in vitro and in vivo tests - Reason / purpose for cross-reference:
- other: Weight of evidence
- Principles of method if other than guideline:
- - Software tool(s) used including version: QSAR
- Model(s) used: DEREK NEXUS Version 6.1.0
- Model description: see field, 'Attached justification''
- Justification of QSAR prediction: see field 'Attached justification' - GLP compliance:
- no
- Justification for non-LLNA method:
- Not applicable
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The QSAR prediction program indicates that there no structural alerts for skin sensitisation.
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Conclusions:
- The substance is not predicted to be a skin sensitiser using the DEREK NEXUS QSRA program.
Referenceopen allclose all
Table 1: Body weights in the pre-screen test
Exp. group |
| Animal No. | Body weights (g) | |
Group | Concentration (w/v%) | Day 1 | Day 6a) | |
Test item | 10.0 | 1 | 22.1 | 22.2 (100.5) |
25.0 | 2 | 22.4 | 23.3 (104.0) | |
50.0 | 3 | 22.4 | 23.1 (103.1) |
Figures in parentheses indicate percentages compared to the initial body weight (Day 1)
Table 2: Thicknesses of auricle in the pre-screen test
Exp. Group | Animal No. | Thickness of auricle (mm) | ||||||
Group | Concentration (w/v%) | Day 1 | Day 3 a) | Day 6 a) | ||||
Test item | Left | Right | Left | Right | Left | Right | ||
| 10.0 | 1 | 0.185 | 0.190 | 0.205 (110.8) | 0.210 (110.8) | 0.190 (102.7) | 0.205 (107.9) |
| 25.0 | 2 | 0.205 | 0.195 | 0.195 (95.1) | 0.210 (107.7) | 0.210 (102.4) | 0.210 (107.7) |
| 50.0 | 3 | 0.180 | 0.190 | 0.200 (111.1) | 0.210 (110.5) | 0.200 (111.1) | 0.195 (102.6) |
Figures in parentheses indicate percentages compared to the initial thicknesses (Day 1)
Table 3: Body weights in the main study
Exp Group | Animal No. | Body weights (g) | ||||
Group | Concentration (w/v%) | Day 1 | Day 6 | |||
Individual | Mean ± S.D. | Individual | Mean ± S.D. | |||
Vehicle Control (DMF) | - | 1 | 22.3 | 22.43 ±1.80 | 22.8 | 23.15 ± 1.88 |
2 | 25.0 | 25.9 | ||||
3 | 21.4 | 21.8 | ||||
4 | 21.0 | 22.1 | ||||
Positive Control (HCA) | 25.0 | 5 | 24.7 | 23.45 ± 2.43 | 24.4 | 23.35 ± 1.92 |
6 | 26.2 | 25.4 | ||||
7 | 20.9 | 21.1 | ||||
8 | 22.0 | 22.5 | ||||
Test item | 10.0 | 9 | 24.5 | 22.90 ± 1.49 | 23.9 | 22.50 ± 1.27 |
10 | 23.8 | 23.0 | ||||
11 | 21.9 | 20.9 | ||||
12 | 21.4 | 22.2 | ||||
25.0 | 13 | 22.2 | 22.55 ± 1.84 | 23.0 | 22.70 ± 1.22 | |
14 | 25.2 | 24.2 | ||||
15 | 21.0 | 21.3 | ||||
16 | 21.8 | 22.3 | ||||
50.0 | 17 | 22.5 | 22.45 ± 1.40 | 23.7 | 22.80 ± 1.34 | |
18 | 24.0 | 24.1 | ||||
19 | 20.6 | 21.2 | ||||
20 | 22.7 | 22.2 |
S.D: Standard deviation
DMF: N,N-dimethylformamide
HCA: α-hexylcinnamaldehyde
Table 4: Clinical signs in the main study
Exp Group | Animal No. | Observation period | ||||||
Group | Concentration (w/v%) | |||||||
Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | |||
Vehicle Control (DMF) | - | 1 | - | - | - | - | - | - |
2 | - | - | - | - | - | - | ||
3 | - | - | - | - | - | - | ||
4 | - | - | - | - | - | - | ||
Positive Control (HCA) | 25.0 | 5 | - | - | - | - | - | - |
6 | - | - | - | - | - | - | ||
7 | - | - | - | - | - | - | ||
8 | - | - | - | - | - | - | ||
Test item | 10.0 | 9 | - | - | - | - | - | - |
10 | - | - | - | - | - | - | ||
11 | - | - | - | - | - | - | ||
12 | - | - | - | - | - | - | ||
25.0 | 13 | -* | -* | -* | - | - | - | |
14 | -* | -* | -* | - | - | - | ||
15 | -* | -* | -* | - | - | - | ||
16 | -* | -* | -* | - | - | - | ||
50.0 | 17 | -* | -* | -* | - | - | - | |
18 | -* | -* | -* | - | - | - | ||
19 | -* | -* | -* | - | - | - | ||
20 | -* | -* | -* | - | - | - |
DMF: N,N-dimethylformamide
HCA: α-hexylcinnamaldehyde
- : no abnormalities detected
*-: test item crystallised on ear (after application)
Table 5: Lymph node weights in the main study
Exp Group | Animal No. | Lymph node weights (g) | ||
Group | Concentration (w/v%) | |||
Individual | Mean ± S.D. | |||
Vehicle Control (DMF) | - | 1 | 4.3 | 4.28 ± 0.21 |
2 | 4.5 | |||
3 | 4.0 | |||
4 | 4.3 | |||
Positive Control (HCA) | 25.0 | 5 | 9.1 | 8.33 ± 0.80 |
6 | 8.5 | |||
7 | 7.2 | |||
8 | 8.5 | |||
Test item | 10.0 | 9 | 4.7 | 4.65 ± 0.34 |
10 | 4.5 | |||
11 | 4.3 | |||
12 | 5.1 | |||
25.0 | 13 | 4.7 | 4.35 ± 0.39 | |
14 | 4.4 | |||
15 | 4.5 | |||
16 | 3.8 | |||
50.0 | 17 | 4.7 | 5.20 ± 0.36 | |
18 | 5.4 | |||
19 | 5.2 | |||
20 | 5.5 |
S.D: Standard deviation
DMF: N,N-dimethylformamide
HCA: α-hexylcinnamaldehyde
Table 6: BrdU labelling indices and stimulation indices in the main study
Exp Group | Animal No. | BrdU labelling index | Stimulation index | |||
Group | Concentration (w/v%) | |||||
Individual | Mean ± S.E. | Individual | Mean ± S.E. | |||
Vehicle Control (DMF) | - | 1 | 0.176 | 0.1560 ± 1.80 | 1.1 | 1.00 ± 0.04 |
2 | 0.153 | 1.0 | ||||
3 | 0.136 | 0.9 | ||||
4 | 0.159 | 1.0 | ||||
Positive Control (HCA) | 25.0 | 5 | 0.568 | 0.4570 ± 0.0395 | 3.6 | 2.93 ± 0.24 |
6 | 0.384 | 2.5 | ||||
7 | 0.426 | 2.7 | ||||
8 | 0.450 | 2.9 | ||||
Test item | 10.0 | 9 | 0.216 | 0.1708 ± 0.0169 | 1.4 | 1.08 ± 0.12 |
10 | 0.143 | 0.9 | ||||
11 | 0.177 | 1.1 | ||||
12 | 0.147 | 0.9 | ||||
25.0 | 13 | 0.233 | 0.1835 ± 0.0215 | 1.5 | 1.18 ± 0.15 | |
14 | 0.185 | 1.2 | ||||
15 | 0.188 | 1.2 | ||||
16 | 0.128 | 0.8 | ||||
50.0 | 17 | 0.169 | 0.2285 ± 0.0322 | 1.1 | 1.48 ± 0.21 | |
18 | 0.243 | 1.6 | ||||
19 | 0.189 | 1.2 | ||||
20 | 0.313 | 2.0 |
S.E: Standard error
DMF: N,N-dimethylformamide
HCA: α-hexylcinnamaldehyde
The query structure does not match any structural alerts or examples of skin sensitisation in Derek. Additionally, the query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitiser.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Conclusion based on a weight-of-evidence approach
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the in vitro/vivo studies conducted on skin, results of these studies indicate that the substance did not meet the test criteria to be classified as a skin sensitiser. In addition, the chemical structure of the substance does not indicate that the substance would be a skin sensitiser. Based on a weight-of-evidence approach plus the fact that the substance did not have a SI value >3 in the LLNA-ELISA type assay support non-classification. The substance does not fulfil the criteria for classification as a skin sensitiser under the CLP regulation (EC1272/2008, as amended).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.