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EC number: 245-322-4 | CAS number: 22914-58-5
- 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
Endpoint summary
Administrative data
Description of key information
A reliable GLP local lymph node assay is available for the substance. The results of which were negative for skin sensitisation effects.
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
- 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/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known: SPF quality
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Housed in suspended solid floor polypropylene cages furnised with softwood woodflakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied ad libitum.
- Water (e.g. ad libitum): Mains tap water provided ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: None noted
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Vehicle:
- dimethylformamide
- Concentration:
- Preliminary screening test: 25 µL of the test item as a 50% w/w suspension in DMF.
Main study: 25 µL of the test item as a 10, 25 or 50% w/w suspension in DMF. - No. of animals per dose:
- Groups of 4 mice were treated
- Details on study design:
- The test item was prepared as a suspension in DMF. The test substance was formulated within 2 hours of being applied to the test system.
Prelininary screening test:
A mouse was treated by daily application of 25 µL of the test substance as a 50% w/w suspension in DMF to the dorsal surface of each ear for three consecutive days. Local skin irritation was socred daily. Any clinical signs of toxicity, if present, were also recorded. The thickness of each ear was measured using a gauge, pre-dose on Day 1 and post dose on Days 3 and 6. Any changes in ear thickness measurements were noted. A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitisation.
Main test:
The preliminary screening test suggested that the test substance would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days. The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
3H-Methyl thymidine Administration: Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 0.25 mL of PBS containing 3H-methyl thymidine giving a total of 20 µCi to each mouse.
Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or ill health during the test were recorded. bodyweights were recorded on Day 1 prior to dosing and Day 6 prior to termination.
Terminal procedures: Five hours following 3HTdR injection all mice were killed by CO2 asphyxiation followed by cervical seperation. The draining auricular lymph nodes from the 4 mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.
Preparation of a single cell suspension: A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL PBS into a petri dish labeled with the study number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for 10 minutes. The pellet was re-suspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was re-suspended in 3 mL of 5% Trichloroacetic acid (TCA).
Determination of 3HTdR incorporation: After approximately 18 hours incubation at approximately 4°C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for 10 minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. 3HTdR incorporation was measured by B-Scintillation counting. The vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left to stand in darkness for approximately 20 minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately 20 minutes, the vials were shaken vigourously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system.
Data Evaluation: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test item will be regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared with control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a 'non-sensitiser'. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not required as all SI values < 3 and therefore EC3 not determined.
- Positive control results:
- The SI index from the latest non-concurrent positive control study using the same vehicle was 7.28 (25% v/v solution) indicating a positive response for skin sensitisation under the test conditions.
- Parameter:
- SI
- Value:
- 1.03
- Variability:
- Not applicable (pooled method)
- Test group / Remarks:
- 10 (% w/w)
- Parameter:
- SI
- Value:
- 1.24
- Variability:
- Not applicable (pooled method)
- Test group / Remarks:
- 25 (% w/w)
- Parameter:
- SI
- Value:
- 1.17
- Variability:
- Not applicable (pooled method)
- Test group / Remarks:
- 50 (% w/w)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: The SI index ranged from 1.03 to 1.24 with no dose dependancy. All results are less than 3 indicating a negative response.
DETAILS ON STIMULATION INDEX CALCULATION : Ratio of 3HTdR incorporation into lymph nodes of test nodes relative to that recorded for the control nodes.
EC3 CALCULATION: Not calculated as all SI values < 3.
CLINICAL OBSERVATIONS: There were no deaths and no signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS: Body weight change of the test animals betwen Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- As the SI Index at all doses was less that 3, the test item was considered to be a non-sensitiser under the conditions of the test.
Reference
Disintegrations per minute, disintegrations per minute/node and Stimulation Index
Concentration (% w/w) in dimethyl formamide |
dpm |
dpm/node |
Stimulation Index |
Result |
Vehicle |
10301.34 |
1287.67 |
NA |
NA |
10 |
10572.98 |
1321.62 |
1.03 |
Negative |
25 |
12799.96 |
1600.00 |
1.24 |
Negative |
50 |
12100.82 |
1512.60 |
1.17 |
Negative |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the available LLNA the determined SI Index at all doses was less that 3. As such the substance is negative for skin sensitisation and no classification is merited in accordance with the CLP Regulation (EC. No 1272/2008, as amended).
No data is available to assess the respiratory sensitising properties of the substance. However, it is very unlikely that a substance not considered to be a skin sensitiser would be a respiratory sensitiser.
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