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EC number: 947-215-4 | CAS number: -
- 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
In a GLP study conducted in compliance with OECD Guideline 4442B with the registered substance, an EC1.6 value could not be determined because SI<1.6 up to 100%.
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:
- 08-21 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 27 April 2017
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- other: CBA/J (CBA/JRj)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest-Saint-Isle, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: 20.2-23.8 g
- Housing: Animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood wood flakes.
- Diet: Teklad Global 16% Protein Rodent Diet (Envigo, 2016), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: at least5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 100 %
Main test: 25, 50 and 100 % - No. of animals per dose:
- Preliminary test: one animal
Main test: 4 females/dose - Details on study design:
- PRELIMINARY TEST:
- The mouse was treated by daily application of 25 μL of the test item undiluted (100 %) to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed daily from day 1. Any signs of toxicity or excessive local irritation noted during this period were recorded. Ear thickness was recorded on Days 1, 3 and 6.
- No cutaneous reactions were noted at the concentration of 100 %. Therefore this concentration was chosen as the highest concentration for the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT:
- Animals were randomly allocated to the groups.
- Name of test method: Local Lymph Node Assay (LLNA:BrdU)
- Criteria used to consider a positive response: Test item should be classified if at least one concentration of the test item results in a SI≥ 1.6, as sensitiser. Any test item failing to produce a SI> 1.6 was classified as a "non-sensitiser". However, the strength of the dose-response relationship, the statistical significance and the consistency of the solvent/vehicle and positive control responses may also be used when determining whether a borderline result (i.e. SI value between 1.6 and 1.9) is declared positive.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of control and test item were applied to the dorsal surface of both ears on Days 1, 2 and 3. On Day 5, 0.5 mL (5 mg/mouse) of BrdU (10 mg/mL) solution was injected by intra-peritoneal route. On day 6 (end of the test), the animals were were sacrificed by pentobarbital sodium and the auricular lymph nodes were excised. Then, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte with ELISA kit. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data
- Positive control results:
- The EC1.6 of the current positive control, tested with HCA, was 18.51%. Therefore, the positive control is classified as sensitiser, as expected.
- Key result
- Parameter:
- other: EC1.6
- Remarks:
- %
- Remarks on result:
- not determinable
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.28
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 100%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item does not require any classification for skin sensitisation in accordance with CLP Regulation (EC) No 1272/2008 and GHS Regulation.
- Executive summary:
In a local lymph node assay (LLNA:BrdU) performed according to OECD Guideline 442B and in compliance with GLP, groups of CBA/J mice (4 females/dose) were topically applied with 25 µL of the registered substance at concentrations of 25, 50 and 100 % to the dorsal surface of both ears for three consecutive days. Vehicle control group of four females received the vehicle (acetone/olive oil (4/1; v/v)). On Day 5, 0.5 mL of BrdU solution (10 mg/mL) was injected by intra-peritoneal route. On Day 6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte with ELISA kit and Stimulation Indices (SI) were calculated. Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study (100% on one animal).
No mortality and no signs of systemic toxicity were noted in the treated and control animals during the test. Dryness of the skin was noted on Day 6 in all animals treated with undiluted test item. No significant increase in ear thickness and in ear weight was noted in animals treated at 25, 50 and 100%. Therefore, the test item has to be considered as not excessively irritant at these concentrations.
Stimulation Index was 1.04, 1.28 and 1.30 for the treated groups at 25, 50 and 100%, respectively. The EC1.6 could therefore not be determined.
The EC1.6 of the current positive control, tested with HCA, was 18.51%. Therefore, the positive control is classified as sensitiser, as expected.
Therefore, the registered substance does not require any classification for skin sensitisation in accordance with CLP Regulation (EC) No 1272/2008 and GHS Regulation.
Reference
Clinical observations and mortality
No mortality and no signs of systemic toxicity were noted in the test and control animals during the test.
Bodyweights
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Local irritation
Dryness of the skin was noted on Day 6 in all animals treated with undiluted test item.
No significant increase in ear thickness and in ear weight was noted in animals treated at 25, 50 and 100 %. Therefore, the test item has to be considered as not excessively irritant at these concentrations.
Table 7.4.1/1: BrdU index & Stimulation index per group and calculation of EC1.6
Groups |
Test item |
Brdu-index (Mean*) |
Stimulation Index (SI) |
Result |
1 |
0 (AOO) |
0.491 |
- |
Negative |
2 |
25 % |
0.510 |
1.04 |
Negative |
3 |
50 % |
0.629 |
1.28 |
Negative |
4 |
100 % |
0.640 |
1.30 |
Negative |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a local lymph node assay (LLNA:BrdU) performed according to OECD Guideline 442B and in compliance with GLP, groups of CBA/J mice (4 females/dose) were topically applied with 25 µL of the registered substance at concentrations of 25, 50 and 100% to the dorsal surface of both ears for three consecutive days. Vehicle control group of four females received the vehicle (acetone/olive oil (4/1; v/v)). On Day 5, 0.5 mL of BrdU solution (10 mg/mL) was injected by intra-peritoneal route. On Day 6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte with ELISA kit andStimulation Indices (SI) were calculated. Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary study (100% on one animal).
No mortality and no signs of systemic toxicity were noted in the treated and control animals during the test. Dryness of the skin was noted on Day 6 in all animals treated with undiluted test item. No significant increase in ear thickness and in ear weight was noted in animals treated at 25, 50 and 100%. Therefore, the test item has to be considered as not excessively irritant at these concentrations.
Stimulation Index was 1.04, 1.28 and 1.30 for the treated groups at 25, 50 and 100%, respectively. The EC1.6 could therefore not be determined.
The EC1.6 of the current positive control, tested with HCA, was 18.51%. Therefore, the positive control is classified as sensitiser, as expected.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No skin sensitisation potential could be identified in a LLNA-Brdu study (conducted according to OECD Guideline 442B) with the registered substance tested up to 100%, therefore the registered substance does not require any classification for skin sensitisation in accordance with CLP Regulation (EC) No 1272/2008 and GHS Regulation.
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.
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