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EC number: 810-766-5 | CAS number: 1802886-42-5
- 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:
- 2016-01-11 to 2016-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-((2-Amino-2-methylethyl)amino)-3-(2-methylphenoxy)propan-2-ol
- Molecular formula:
- C13H22N2O2
- IUPAC Name:
- 1-((2-Amino-2-methylethyl)amino)-3-(2-methylphenoxy)propan-2-ol
- Reference substance name:
- 1-((2-Amino-1-methylethyl)amino)-3-(2-methylphenoxy)propan-2-ol
- Molecular formula:
- C13H22N2O2
- IUPAC Name:
- 1-((2-Amino-1-methylethyl)amino)-3-(2-methylphenoxy)propan-2-ol
- Reference substance name:
- 3,3'-(Propane-1,2-diylbis(azanediyl))bis(1-(2-methylphenoxy)propan-2-ol)
- Molecular formula:
- C23H34N2O4
- IUPAC Name:
- 3,3'-(Propane-1,2-diylbis(azanediyl))bis(1-(2-methylphenoxy)propan-2-ol)
- Reference substance name:
- 1,3-Bis(2-methylphenoxy)propan-2-ol
- Molecular formula:
- C17H20O3
- IUPAC Name:
- 1,3-Bis(2-methylphenoxy)propan-2-ol
- Reference substance name:
- unknown compounds
- Molecular formula:
- not applicable (unknown compounds)
- IUPAC Name:
- unknown compounds
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT. H-1103, Budapest, Cserkesz u. 90. Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-11 weeks old (at start of the main test)
- Weight at study initiation: 17.3 – 20.6 g
- Housing: Grouped caging (5 animals/cage)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 10%, 5%, 2.5% and 1% (w/v)
- No. of animals per dose:
- 5 females per group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The test item is a viscous liquid, which was adequately miscible with the vehicle (propylene glycol).
- Irritation: Ear thickness was greater or equal than 25% at high test concentrations (75%, 50% or 25%, w/v) in the first range finding test. No irritation was observed at 10%, 5%, 2.5% and 1% (w/v) test item formulations in the second range finding test.
- Lymph node proliferation response: No assessement of lymph node proliferation was done.
- Other: Mortality (1/2 animals) was observed in the 75% (w/v) dose group on day 5. Systemic toxicity (decreased body weight, loss of hair, scab) was observed at high concentrations (75 %, 50 % or 25 %, w/v) in the first range finding test.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- In the main test 35 female CBA/Ca Ola Hsd mice were allocated to 7 groups of 5 animals each:
- 4 groups received the appropriate formulation of the test item at concentrations of 10%, 5%, 2.5% and 1% (w/v)
- two negative control groups were used: 1. vehicle control for the test item (propylene glycol) and 2. vehicle control for positive control (acetone:olive oil 4:1 (AOO))
- the positive control group received hexyl cinnamic aldehyde (25% (w/v) in AOO)
- Each mouse was topically treated with 25 μL of the appropriate formulations of the test item, of the positive control substance and of the vehicle. The formulations were applied, with a pipette, on the dorsal surface of each ear.
- Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There were no treatments on Days 4, 5 and 6.
- Criteria used to consider a positive response: That exposure to at least one concentration (non-irritating, non-toxic) of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index (SI ≥ 3). However, the strength of the dose-response, the statistical significance and the consistency of the solvent/vehicle and PC responses may also be used when determining whether a borderline result is declared positive.
TREATMENT PREPARATION:
The test item was weighed and formulations prepared with the vehicle in a final volume of 1 mL using volumetric vials and mechanical agitation. All formulations were freshly prepared just before the daily treatments. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The measured DPM values corrected with the mean background value were used for statistical analysis of the proliferation data. The heterogeneity of variance between the groups treated with the test item and the vehicle control (propylene glycol) was checked by Bartlett's test. Since significant heterogeneity was detected, the normal distribution of data was examined by Kolmogorow-Smirnow test followed by the non-parametric method of Kruskal-Wallis One-Way analysis of variance. As a results of this analysis the inter-group comparisons was performed using Mann-Whitney U-test to assess the significance of inter-group differences. Significance of the positive control response was evaluated by t-test versus the relevant vehicle control (acetone:olive oil 4:1 mixture). Significance of the dose-response was evaluated by linear regression made with Microsoft Excel Software.
Results and discussion
- Positive control results:
- The positive control substance induced the appropriate stimulation (an SI ≥ 3) compared to the relevant (AOO) control: the calculated SI value was 9.0.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 26.3
- Test group / Remarks:
- Dose group 10 % in PG
- Key result
- Parameter:
- SI
- Value:
- 8.9
- Test group / Remarks:
- Dose group 5 % in PG
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- Dose group 2.5 % in PG
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Dose group 1 % in PG
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control for test item: PG
- Key result
- Parameter:
- SI
- Value:
- 9
- Test group / Remarks:
- Positive control: 25 % HCA in AOO
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control for the positive control: AOO
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Visually larger lymph nodes compared to the relevant vehicle controls (AOO or PG) were observed in the positive control group and in the 10 % or 5 % (w/v) test item treated groups. Visual appearance of the lymph nodes was normal in the negative (vehicle) control groups and in the 2.5 % or 1 % (w/v) test item treated groups. Significant lymphoproliferation (SI ≥ 3) was observed for the test item at test concentrations of 10 % and 5 % (w/v). No significant lymphoproliferation was observed at the other test concentrations (2.5 % or 1 %, w/v). The corresponding stimulation index values were 26.3, 8.9, 1.1 and 1.0 at treatment concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively.
CLINICAL OBSERVATIONS
No mortality or symptoms of systemic toxicity were observed in any treatment group. No sign of irritation (indicated by an erythema score ≥ 3) or other local effects were observed in any treatment groups.
BODY WEIGHTS
No significant, treatment related effect on the body weights was observed in any treatment group.
Any other information on results incl. tables
1. Range finding test
Test item residuals were observed on the ears in all dose groups which made surface of the ears sticky. It is considered that the measured ear thickness values (especially on day 5) could be affected by the test item residuals also.
Table 1: Mean DPM and DPN values for all groups in the main test
Test group |
Mean DPM (SD) |
Mean DPN (SD) |
Vehicle control (AOO) |
1229.7 (92.6) |
615 (46.3) |
Positive control (HCA) |
11091.9 (6837.4) * T |
5546 (3418.7) |
10% test item in PG |
22222.3 (10511.2) ** U |
11111 (5255.6) |
5% test item in PG |
7509.7 (5694.1) ** U |
3755 (2847.1) |
2.5% test item in PG |
888.5 (542.0) NS U |
444 (271.0) |
1% test item in PG |
824.5 (578.9) NS U |
412 (289.5) |
Vehicle control (PG) |
843.9 (567.6) |
422 (283.8) |
HCA = α-Hexylcinnamaldehyde
AOO = Acetone: Olive oil 4:1 (v/v) mixture
PG = Propylene glycol
* = Significant; p < 0.05
** = Significant; p < 0.01
NS = Not significant
T = t-test versus control (AOO)
U = Mann-Whitney U-test versus control (PG)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the EC3 value of 3.1%, the test item was considered a moderate skin sensitizer in this LLNA(EC3 > 2 %).
- Executive summary:
The aim of this study (OECD 429) was to determine the skin sensitization potential of the test item following dermal exposure in the Local Lymph Node Assay. Individual approach was used in this test. The test item was a viscous liquid. Propylene glycol (PG), one of the vehicles preferred by the relevant guidelines, was selected to be used for formulation. The test item was adequately miscible with the vehicle. The maximum dose selection based on results of two consecutive Dose Range Finding (DRF) tests performed according to the relevant guidelines. Adverse effects (systemic toxicity and irritation) was observed at high test concentrations (75 %, 50 % or 25 %, w/v), hence the test item was examined in the main test at 10 %, 5 %, 2.5 % and 1 % (w/v) concentrations as formulations in PG. Appropriate positive control, furthermore two negative control groups (dosed with the vehicles of the test and positive control groups, respectively) were employed. The positive control item (α-Hexylcinnamaldehyde [HCA]; 25 % (w/v) in AOO) induced the appropriate stimulation over the control (SI = 9.0), thus confirming the validity of the assay. No mortality was observed during the main test. No significant, treatment related effect on body weights or other sign of systemic toxicity were observed in any treatment group. No visible signs of irritation or other local effect were observed in any treatment groups. Significant lymphoproliferation (SI ≥ 3) was observed for the test item at test concentrations of 10 % and 5 % (w/v). No significant lymphoproliferation was observed at the other test concentrations (2.5 % or 1 %, w/v). The corresponding stimulation index values were 26.3, 8.9, 1.1 and 1.0 at treatment concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively. The measured individual DPM values corrected with the mean background value were statistically evaluated. Statistically significant increase of the proliferation values was observed in the positive control group by t-test versus AOO control (p < 0.05). Statistically significant differences compared to the vehicle control (PG) were observed in the 10% and 5% (w/v) test groups (p < 0.01, evaluated by Mann-Whitney U-test). The dose-response relationship, evaluated by linear regression using the SI values, was statistically significant (p = 0.015, r = 0.98). According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation observed at 10 % and 5 % (w/v) concentrations and the significant dose-response correlation are considered evidence that the test item is a skin sensitizer.
The calculated EC3 value based on dose-response curve analysis was 3.1 % (w/v) in this LLNA. Based on the EC3 value of 3.1%, the test item was considered a moderate skin sensitizer in this LLNA(1 ≤ EC3 ≤ 10).
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