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EC number: 641-048-8 | CAS number: 110839-13-9
- 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:
- from 2008-05-13 to 2008-06-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 641-048-8
- Cas Number:
- 110839-13-9
- Molecular formula:
- C37H48N4O4
- IUPAC Name:
- Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Hungarian Supplier: WOBE Kereskedelmi Kft. H-1164, Budapest, Garmada u. 10.
- Age at study initiation: Young adult, 9 - 10 weeks old, age-matched within one week
- Weight at study initiation: The weight variation in animals involved in the study did not exceed ± 20 % of the mean weight.
- Housing: Individual caging Type II. polypropylene/ polycarbonate
- Diet: Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum
- Water (e.g. ad libitum): Tap water from municipal supply, as for human consumption from 500 mL bottle ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes: 8 - 12 air exchange/hour by central air-condition system.
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 25, 10, 5, 2.5 % (w/v)
- No. of animals per dose:
- 4 female/treatment group
- Details on study design:
- In the main assay, twenty female CBA/Ca mice were allocated to five groups of four animals each:
- Four groups received the appropriate formulation of the test item at concentrations of 25, 10, 5 and 2.5 % (w/v)
- the negative control group received the solvent propylene glycol (PG)
Each substance was applied on the external surface of each ear (25 µL/ear) for three consecutive days (Day 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by in corporation of tritiated methyl-thymidine (3HTdR) and the values obtained were used to calculate the stimulation indices (SI) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI >= 3) was noted for HCA with stimulation index value of 7.5, in accordance with previous data.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 26
- Test group / Remarks:
- 25 % test group
- Key result
- Parameter:
- SI
- Value:
- 13
- Test group / Remarks:
- 10 % test group
- Key result
- Parameter:
- SI
- Value:
- 12.3
- Test group / Remarks:
- 5 % test group
- Key result
- Parameter:
- SI
- Value:
- 7.5
- Test group / Remarks:
- 2.5 % test group
Any other information on results incl. tables
A significant lymphoproliferative response (SI >= 3) was noted for the test item at all of the applied concentrations. The stimulation index values were 26.0, 13.0, 12.3 and 7.5 at concentrations of 25 %, 10 %, 5 % and 2.5 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item, dissolved in an appropriate solvent up to the maximum feasible concentration (25 %), was shown to have sensitisation potential in the Local Lymph Node Assay.
- Executive summary:
Local Lymph Node Assay according to OECD 429 and Commission Directive 2004/73/EC, B.42 was performed with CBA/Ca Ola Hsd mice. The aim of this study was to determine the skin sensitisation potential of the test item following dermal exposure in the Local Lymph Node Assay. The maximum concentration of test item in an acceptable solvent was established according to the principles of the relevant guidelines. The maximum attainable concentration based on solubility and applicability on the ears was 25 % in Propylene glycol (PG). A preliminary irritation/toxicity test was performed showing that the maximum concentration of test item of 25 % in PG was acceptable.
In the main assay twenty female CBA/Ca mice were allocated to five groups of four animals each:
- four groups received the appropriate formulation of the test item at concentrations of 25 %, 10 %, 5 % or 2.5 %,
- the negative control group received the solvent (PG).
Each substance was applied on the external surface of each ear (25 µL/ear) for three consecutive days (Day 1, 2 and 3) at the appropriate concentrations. 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).
No mortality or systemic clinical signs were observed during the study. No treatment related effect on the body weights was observed. No sign of a classical irritation was observed in any of the treated groups.
Significant loss of hair was observed in the 25 % dose group (4/4 animals) from Day 2 after the second treatment: the affected area enlarged after the subsequent treatment and the skin was dry and exfoliating on the hairless area (3/4 animals) from Day 4 or 5 to the study termination. No redness or damage of the skin integrity was observed. No cutaneous effect was observed in the other dose groups.
A lymphoproliferative response (SI >= 3) was noted for the test item at all of the applied concentrations. The stimulation index values (SI) were 26.0, 13.0, 12.3 and 7.5 at concentrations of 25 %, 10 %, 5 % and 2.5 %, respectively. The stimulation index values corresponded to the conventional biological dose-response. The EC3 value (potency) was below the lowest tested concentration of 2.5 %.
The result of the latest reliability check (performed within an interval of no longer than six months, Study code: 08/661-037E) was used to demonstrate the appropriate performance of the assay in accordance with the OECD guideline 429 (Ref. 1). The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI >= 3) was noted for HCA with stimulation index value of 7.5 in accordance with the historical control data. The result confirms the validity of the LLNA in this laboratory.
Under the conditions of the present assay the test item, dissolved in an appropriate solvent up to the maximum feasible concentration (25 %), was shown to have sensitisation potential (sensitiser) in the Local Lymph Node Assay.
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