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EC number: 452-330-3 | 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
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Not sensitising, Local Lymph Node Assay, OECD 429, Rattray 2004
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:
- 10 September 2003 to 16 September 2003
- 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:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 20.4 g to 23.3 g
- Housing: A maximum of 4 mice were housed per cage
- Diet: ad libitum
- Water: ad libitum, mains water
- Acclimation period: A minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
IN-LIFE DATES: From: 10 September 2003 To: 16 September 2003 - Vehicle:
- dimethylformamide
- Concentration:
- 1, 2.5 or 10 % w/v
- No. of animals per dose:
- Animals were tested in groups of four.
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The results are expressed as disintegrations per minute (dpm) value per lymph node for each group. The activity of each test group is then divided by the activity of the vehicle control group to give a test:control ratio for each concentration. The criterion for a positive response is that one or more concentrations of the test material should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. The assay is able to identify those materials that elicit responses in standard guinea pig test for skin sensitisation (Kimber et al 1994). Consequently, a test material which does not fulfil the above criterion is designated as unlikely to be a sensitiser.
TREATMENT PREPARATION AND ADMINISTRATION:
A top dose of 10 % w/v of the test material was decided upon in order to maximise any potential sensitisation response without the risk of inducing a toxic response. Approximately 25 µL of 1 %, 2.5 % or 10 % w/v preparation of the test substance in DMF was applied using a variable volume micro-pipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using DMF alone. The procedure was repeated daily for 3 consecutive days.
Three days after the third application, all the animals were injected, via the tail vein, with approximately 250 µL of phosphate buffered saline (PBS) containing approximately 20 µCi of a 2.0 Ci/mmol specific activity 3H-methyl thymidine. Approximately 5 hours later, the animals were humanely killed by inhalation of halothane vapour followed by cervical dislocation. The draining aurcular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a contained of PBS.
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze. The cell suspensions were then washed three times by centrifugation with approximately 10 mL of PBS. Approximately 3 mL of 5 % w/v trichloroacetic acid (TCA) was added and, after overnight precipitation at 4 °C, the samples were pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1 mL of TCA.
The lymph node suspensions were transferred to scintillation vials and 10 mL of scintillant (Optiphase) was added prior to β-scintillation counting used a Packard Tri-Carb 2500TR Liquid Scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 2.5 %, 5 % and 10 % w/v in acetone resulted in a greater than 3-fold increase in isotope incorporation at all three concentrations. Therefore, hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
- Key result
- Parameter:
- SI
- Value:
- 0.74
- Test group / Remarks:
- 1% w/v
- Key result
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 2.5% w/v
- Key result
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- 10% w/v
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A top dose of 10 % w/v of the test material was decided upon in order to maximise any potential sensitisation response without the risk of inducing a toxic response. Under the conditions of the test, the isotope concentration was less than three-fold at all test concentrations and therefore, the test material is considered to be unlikely to be a skin sensitiser. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin sensitisation potential of the test material was determined in accordance with the standardised guidelines OECD 429 and EPA OPPTS 870.2600 using the mouse Local Lymph Node Assay. The test substance was applied as 1 %, 2.5 % or 10 % w/v preparation in dimethylformamide with a top dose of 10% w/v decided upon in order to maximise any potential sensitisation response without the risk of inducing a toxic response. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. The isotope concentration induced by the test material was less than three-fold at all test concentrations and therefore the test material is considered to be unlikely to be a skin sensitiser.
Reference
Table 1: Results
Concentration (% w/v) |
Number of lymph nodes assayed |
Disintegrations per minute (dpm) |
dpm per lymph node |
Test control ratio |
|
0 (vehicle only) Main test |
8 |
3539 |
442 |
N/A |
|
Test material |
1 |
8 |
2598 |
325 |
0.74 |
2.5 |
8 |
4621 |
578 |
1.31 |
|
10 |
8 |
3908 |
489 |
1.11 |
|
0 (vehicle only) Positive control |
8 |
2570 |
321 |
N/A |
|
Hexylcinnamaldehyde |
2.5 |
8 |
16088 |
2011 |
6.26 |
5 |
8 |
15659 |
1957 |
6.10 |
|
10 |
8 |
15611 |
1951 |
6.08 |
Table 2: Bodyweights
Dose |
Animal number |
Bodyweight (g) |
|
Day 1 |
Day 6 |
||
0 % w/w (vehicle control) |
1 |
21.9 |
22.7 |
2 |
20.9 |
21.1 |
|
3 |
20.4 |
20.9 |
|
4 |
21.5 |
23.2 |
|
1 % w/v test material |
5 |
22.6 |
24.1 |
6 |
23.3 |
23.4 |
|
7 |
22.7 |
23.7 |
|
8 |
21.0 |
21.8 |
|
2.5 % w/v test material |
9 |
23.2 |
23.5 |
10 |
21.1 |
21.0 |
|
11 |
20.4 |
22.9 |
|
12 |
19.5 |
20.6 |
|
10 % w/v test material |
13 |
25.4 |
23.2 |
14 |
23.0 |
24.9 |
|
15 |
20.7 |
21.9 |
|
16 |
23.1 |
24.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the test material was determined in accordance with the standardised guidelines OECD 429 and EPA OPPTS 870.2600 using the mouse Local Lymph Node Assay. The test material was applied as 1 %, 2.5 % or 10 % w/v preparation in dimethylformamide with a top dose of 10% w/v decided upon in order to maximise any potential sensitisation response without the risk of inducing a toxic response. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. The isotope concentration induced by the test material was less than three-fold at all test concentrations and therefore the test material is considered to be unlikely to be a skin sensitiser.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
The available data is considered to be complete and the conclusion, not sensitising, was taken forward for risk assessment.
Migrated from Short description of key information:
Not sensitising, female mouse, OECD 429, EPA OPPTS 870.2600, Rattray 2004
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material did not elicit a response in the Local Lymph Node Assay and therefore does not meet the criteria for classification as a skin sensitiser.
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