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EC number: 469-500-8 | CAS number: 857035-95-1
- 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:
- 12 September 2006 to 25 September 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- 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
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest Saint Isle, France
- Age at study initiation: 9 weeks
- Weight at study initiation: 21.1 g +/- 1.1 g
- Housing: disposable crystal polystyrene cages
- Diet (e.g. ad libitum): SsniffR/M-H pelleted diet
- Water (e.g. ad libitum): tap water (filtered using a 0.22 micron filter)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- four
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0, 2.5, 5, 10, 15, 18 %
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solution was obtained at the maximum concentration of 15% and the best homogeneous suspension was obtained at the concentration of 18%.
- Irritation: The test item was non-irritant in the preliminary test, whatever the concentration tested.
- Lymph node proliferation response: not evaluated.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node cell proliferative responses were measured as described by Kimber and Dearman (1991).
- Criteria used to consider a positive response: The test item was considered as a skin sensitizer when the SI for a dose group is > 3.
TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was
applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- No unscheduled death occurred in the study. Hypoactivity was observed on day 6, in one female treated with the test item at the concentration of
2.5%.
Local irritation
On day 6, crusts were observed in 2/4 and 1/4 females treated with the test item at the concentrations of 15 and 18%, respectively.
A yellow coloration of the skin of the ears was noted in all the animals treated with the test item at the concentration of 15 or 18%.
No increase in ear thickness was observed in the animals of the treated groups.
Proliferation assay
No significant lymphoproliferation was noted at any tested concentration, while significant lymphoproliferation was observed with HCA at 25%.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: See table 1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table 1
Any other information on results incl. tables
Table 1: Results of LLNA: Stimulation Index and Disintegration per minute
Sample Description Test or Control Group |
Vehicle |
2.5% |
5% |
10% |
15% |
18% | Positive control |
Stimulation Index (SI) |
- |
0.80 |
1.74 |
1.56 |
2.51 |
1.84 | 5.92 |
Disintegration per minute and per group |
537.42 |
432.42 |
936.89 |
837.19 |
1349.33 |
987.33 | 3179.63 |
Disintegration per minute and per node |
67.18 | 54.05 | 117.11 | 104.65 | 168.67 | 123.42 | 397.45 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item did not induce contact sensitization in the murine Local Lymph Node Assay.
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