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EC number: 619-596-4 | CAS number: 915095-86-2
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- IN 78280
- IUPAC Name:
- IN 78280
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: IN 00078280
Supplier: Boehringer Ingelheim Pharmaceuticals
Batch No.: 7889-142
Expiration Date: Dec 2007
Physical Description: Off white powder
Composition/Purity: 100% (NMR)
Stability: Stability data on bulk test material was not
provided by the Sponsor.
Storage Conditions: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME 04609
- Age at study initiation: 8-9 weeks at start of dosing; records of dates of birth of animals used in this study are retained in the Calvert archives
- Weight at study initiation: 18 to 25 grams at the outset (Day 1) of the study
- Housing: Animals were group housed (5 per cage) upon receipt in compliance with National Research Council “Guide for the Care and Use of Laboratory Animals”. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): Animals had access to Certified Rodent Diet 7012C ad libitum. The lot number(s) and specifications of each lot used are archived at Calvert.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: Study animals were acclimated to their housing for a minimum of 6 days prior to their first day of dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 30.6 °C
- Humidity (%): 30 to 64%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10 %, 25 %, 50 %,
- No. of animals per dose:
- 25 total; 5 per concentration; 5 per positive and negative control, respectively
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The vehicle and dose levels were selected by conducting a solubility test. In order of preference the vehicles of choice were acetone/olive oil (4:1 v/v) (AOO), dimethylformamide (DMF), methyl ethyl ketone (MEK) propylene glycol (PG), dimethyl sulfoxide (DMSO). The recommended doses were
selected from the concentration series 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% (w/v) etc, the top dose being the highest level that could be achieved.
- Irritation: The doses for this assay were selected from the concentrations series 100%, 50%, 25%, 10%, 5%, 2.5%, 1.0%, 0.5% etc. Three consecutive concentrations were chosen, the top one being the highest level that could be achieved based on solubility while avoiding systemic toxicity and excessive local irritation.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Increases in 3H-thymidine incorporation relative to the vehicle-treated control were derived for each group and recorded as stimulation indices (SI). The criterion for a positive response is that one or more concentrations of a test article elicits a 3-fold or greater increase in isotope incorporation relative to the vehicle control as indicated by the SI.
TREATMENT PREPARATION AND ADMINISTRATION: Groups of 5 CBA/J female mice were treated on the dorsal surface of both ears once per day for 3 days with IN 00078280 at 10, 25 or 50%, with the vehicle (acetone/olive oil (4:1, v/v) [AOO]), or with the positive control (35% Hexylcinnamaldehyde [HCA]). On Day 6, the mice were injected, i.v., with 20 μCi of 3H-thymidine in sterile saline. Five hours later, the mice were euthanized and the draining auricular lymph nodes were removed. The lymph node cells were precipitated with 5% trichloroacetic acid (TCA) and the pellets counted in a ß-scintillation counter to determine incorporation of the 3Hthymidine. This study was run three times since in the first two runs the vehicle control results were high resulting in SI values <3 for the positive control group, which invalidated the data. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean DPM for each group was evaluated using SYSTAT version 9.01, developed by SPSS, Inc. Increases in 3H-thymidine incorporation relative to the vehicle-treated control were derived for each group and recorded as stimulation indices (SI).
Individual DPM values were analyzed by log transformation (base 10) of the data. The evaluation of the equality of means for the DPM and body weight data were made by a one-way analysis of variance using the F distribution to assess statistical significance. If statistically significant differences between the means were found, a Dunnett’s test was used to determine the degree of significance from the control means.
Results and discussion
- Positive control results:
- There were 5 positive controls.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- Groups of 5 CBA/J female mice
- Remarks on result:
- other: Treatment with IN 00078280 at nominal concentrations of 10, 25 or 50% did not result in an SI of 3 or greater. Therefore, based on the data from this study, IN 00078280 is not considered to have skin sensitizing potential.
Any other information on results incl. tables
Group | Treatment | Dose | DPM (mean +- sem) | SI | Result1 |
1 | AOO | - | 1166 +-396 | - | negative |
2 | IN00078280 | 10% | 472 +-65 | 0.4 | - |
3 | IN00078280 | 25% | 1391 +-242 | 1.2 | - |
4 | IN00078280 | 50% | 646 +-232 | 0.6 | - |
5 | HCA | 35% | 4600 +-671*** | 3.9 | + |
1Test/control ratio of 3.0 or greater represents a positive result
***Statistically significant difference when log DPM compared to the vehicle control group (group 1) (p < 0.001)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A test material is considered to have skin sensitizing activity if, at one or more concentrations, it induces a 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control group. Thus, a stimulation index (SI) ≥ 3.0 is regarded as a positive response. Although the dosing solution concentrations were not verified, treatment with IN 00078280 at nominal concentrations of 10, 25 or 50% did not result in an SI of 3 or greater.
Therefore, based on the data from this study, IN 00078280 is not considered to have skin sensitizing potential.
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