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EC number: 700-938-7 | CAS number: 72716-26-8
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin sensitisation
Non-sensitiser, OECD 429, EU Method B. 42, LLNA, Váliczkó 2013.
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:
- key study
- Study period:
- 09 December 2012 to 05 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: CBA/J Rj mice
- Age at study initiation: Main Test: 9 weeks old (age-matched, within one week); Preliminary Test 8 week old mice.
- Weight at study initiation: Main Test: 20.1 - 21.6 g (the weight variation in animals in the study did not exceed ± 20 % of the mean weight); Preliminary Test: 20.3 - 21.1 g.
- Housing: In groups in type II polypropylene / polycarbonate cages.
- Diet: Complete diet for rats/mice was provided ad libitum.
- Water: Tap water from the municipal supply was provided ad libitum.
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchange/hour.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m. - Vehicle:
- other: 1 % Pluronic in distilled water
- Concentration:
- 25, 10 and 5 % (w/v)
- No. of animals per dose:
- Four per dose, including both negative and positive controls.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The maximum concentration of test material in an acceptable solvent was established according to OECD guideline 429. The following standard OECD vehicles were assessed: AOO (acetone:olive oil 4:1 (v:v) mixture), N,N-dimethylformamide, Methyl ethyl ketone, Propylene glycol, Dimethyl sulfoxide and 1 % aqueous Pluronic® PE9200 (1% Pluronic). The best vehicle taking into account the test material characteristics and its usage was considered to be 1 % Pluronic. The highest achievable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test material was, 25 (w/v) %.
- Irritation: No irritation was observed in the preliminary test, detailed in the field “any other information on materials and methods incl. tables”.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The test material is regarded as a sensitizer if both of the following criteria are fulfilled:
> That exposure to at least one concentration of the test material resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
>The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
- Negative control: Four animals were treated with the vehicle only (1 % Pluronic).
TREATMENT PREPARATION AND ADMINISTRATION
Preparation: The test material was weighed and formulations prepared daily on a weight:volume basis (as (w/v) %).
Administration: animals were topically dosed with 25 μL of the appropriate formulation using 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 was no treatment on Days 4, 5 and 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 25 w/v %
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 10 w/v %
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 5 w/v %
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM values were were 2201.0, 1105.0 and 1255.0 at concentrations of 25, 10 and 5 (w/v) %, respectively. The DPM per node (DPN) values were were 275.1, 138.1 and 156.9 at concentrations of 25, 10 and 5 (w/v) %, respectively.
- Interpretation of results:
- other: not classified according to EU criteria
- Conclusions:
- Under the conditions of the test, no mortality, systemic clinical signs, treatment related effects on body weights, or indications of any irritancy at the site of application were observed in any of the treatment groups. Test material precipitate was observed in the 25 (w/v) % dose group on Days 1-5 and in the 10 and 5 (w/v) % dose groups on Days 2-3. The observed stimulation index values were 1.6, 0.8 and 0.9 at concentrations of 25, 10 and 5 (w/v) %, respectively. Since the measured indices were less than 3 the test material is considered to be a non-sensitizer.
- Executive summary:
The skin sensitisation potential of the test material was determined in a GLP study conducted in accordance with the standardised guidelines OECD 429 and EU Method B. 42, using the local lymph node assay method.
In the definitive, test animals were administered the test material at 25, 10 and 5 (w/v) %, formulated in 1 % Pluronic aqueous solution. The dosing range and vehicle were selected based on the results of two preliminary studies, a compound solubility test and a preliminary irritation/toxicity test. Negative vehicle and positive controls (97.8 % hexyl cinnamic aldehyde) were run concurrently for comparison.
Four female CBA/J Rj mice per dose were topically administered 25 µL of the appropriate test material formulation on the dorsal surface of each ear for three consecutive days (days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (³HTdR) and the values obtained were used to calculate stimulation indices (SI).
Under the conditions of the test, no mortality, systemic clinical signs, treatment related effects on body weights, or indications of any irritancy at the site of application were observed in any of the treatment groups. Test material precipitate was observed in the 25 (w/v) % dose group on Days 1-5 and in the 10 and 5 (w/v) % dose groups on Days 2-3. The observed stimulation index values were 1.6, 0.8 and 0.9 at concentrations of 25, 10 and 5 (w/v) %, respectively. Since the measured indices were less than 3, the test material is considered to be a non-sensitizer.
Reference
OBSERVATIONS
- Clinical observations: No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test mateiral precipitate was observed in the 25 (w/v) % dose group on Days 1-5 and in the 10 and 5 (w/v) % dose groups on Days 2-3.
- Bodyweight measurement: No treatment related effects were observed on body weight.
- Lymph nodes: The appearance of the lymph nodes was normal in the negative (vehicle) control group and in all test item treated groups. Larger than normal lymph nodes were observed in the positive control group.
INTERPRETATION OF OBSERVATIONS
Since, there were no confounding effects of irritation or systemic toxicity at the applied concentrations, the proliferation values obtained are considered to reflect the real potential of the test material to cause lymphoproliferation in the Local Lymph Node Assay. The resulted stimulation indexes observed under these exaggerated test conditions were considered to be good evidence that the test material is a non-sensitizer (see Figure 1).
POSITIVE CONTROL RESUTLS
No mortality, cutaneous reactions or signs of toxicity were observed for the positive control substance in the study. A significant lymphoproliferative response (stimulation index value of 5.4) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay.
Furthermore, the DPN values observed for the vehicle and positive control substance in this experiment were within the historical control range. Each treated and control group included 4 animals.
Table 2: DPM, DPN and Stimulation Index Values for all Groups
Test Group |
Measured DPM/group |
DPM |
No. of Lymph Nodes |
DPN |
Stimulation Index |
Background (5 (w/v) % TCA) |
30 |
- |
- |
- |
- |
Negative Control |
1442 |
1412.0 |
8 |
176.5 |
1.0 |
Test Material 25 (w/v) % |
2231 |
2201.0 |
8 |
275.1 |
1.6 |
Test Material 10 (w/v) % |
1135 |
1105.0 |
8 |
138.1 |
0.8 |
Test Material 5 (w/v) % |
1285 |
1255.0 |
8 |
156.9 |
0.9 |
Positive Control |
7721 |
7691.0 |
8 |
961.4 |
5.4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the key study (Váliczkó, 2013), the skin sensitisation potential of the test material was determined in a GLP study conducted in accordance with the standardised guidelines OECD 429 and EU Method B. 42, using the local lymph node assay method.
In the definitive, test animals were administered the test material at 25, 10 and 5 (w/v) %, formulated in 1 % Pluronic aqueous solution. The dosing range and vehicle were selected based on the results of two preliminary studies, a compound solubility test and a preliminary irritation/toxicity test. Negative vehicle and positive controls (97.8 % hexyl cinnamic aldehyde) were run concurrently for comparison.
Four female CBA/J Rj mice per dose were topically administered 25 µL of the appropriate test material formulation on the dorsal surface of each ear for three consecutive days (days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).
Under the conditions of the test, no mortality, systemic clinical signs, treatment related effects on body weights, or indications of any irritancy at the site of application were observed in any of the treatment groups. Test material precipitate was observed in the 25 (w/v) % dose group on Days 1-5 and in the 10 and 5 (w/v) % dose groups on Days 2 - 3. The observed stimulation index values were 1.6, 0.8 and 0.9 at concentrations of 25, 10 and 5 (w/v) %, respectively. Since the measured indices were less than 3, the test material is considered to be a non-sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin Sensitisation
According to the criteria outlined in Regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification as a skin sensitizer.
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