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EC number: 445-910-2 | CAS number: 1388152-30-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 December 2000- 12 December 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was completed in 2000 according to an OECD guideline and in accordance with GLP. The material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: first stage in the assessment of skin sensitization (OECD guideline for testing chemicals, No 406 1992 "Skin Sensitization".)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 445-910-2
- EC Name:
- -
- Cas Number:
- 1388152-30-4
- Molecular formula:
- Hill formula: C24 H32 N2 O7 Si CAS formula: C15 H20 O3 Si . C9 H12 N2 O4
- IUPAC Name:
- (1R,2R)-1,3-Dihydroxy-1-(4-nitrophenyl)propyl-2-ammonium (1R, 5S)-5-(dimethylphenylsilyl)-2-(hydroxymethyl)cyclopent-2-ene-1-carboxylate
- Details on test material:
- Test material is a beige solid which was received at testing laboratory on 27 October 2000 and stored at room temperature in the dark.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male
- Details on test animals and environmental conditions:
- At the start of the study the mice were in the weight range of 19 to 22 grams and were six to eight weeks old. Free access to mains drinking water and food was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 19 to 25 C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness. All doses were freshly made for day 0, 1, 2 administration.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Treated with 50 ul ( 25 ul per ear) of the test solution in acetone/olive oil(4:1) at concentrations of 0.1%, 1% and 10% w/w for 3 consecutive days
- No. of animals per dose:
- Three groups of four animals each were treated at each concentration group and a further group of four animals were treated as a control group with acetone/olive oil (4:1) alone.
- Details on study design:
- The 3 groups were treated for three days with the test formulation by using a micropipette whose tip is used to spread the formulation over the dorsal surface of each ear. On Day 5 all mice were injected with 250 ul of a phosphate buffered saline solution containing 3H-methyl thymidine (3HTdR ) to the tail vein giving a total of 20 uCi to each mouse. All animals were observed on Day 0, 1, and 2 for the remainder of the study. Any signs of toxicity or ill health were noted. Body weights of each mouse were recorded before dosing and before termination. Five hours after administration of 3HTdR all mice were killed by carbon dioxide asphyxiation and their auricular lymph nodes were excised and pooled for each experimental group. A 1 ml of phosphate buffered saline was added to each set of lymph nodes. Preparation of a single cell suspension was completed for the pooled lymph nodes cells following standard procedure. Determination of the 3HTdR incorporation was completed by measuring radioactive disintegration for each experimental group lymph node cells by using a beta-scintillation counter. Note that injection of one control and one animal in the 1 % w/v group was unsuccessful and they were removed from the study.
- Positive control substance(s):
- other: 1-chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- Positive controls data using 1-chloro-2,4-dinitrobenzene in acetone/olive oil 4:1 at concentrations of 0.1%, 0.25% and 0.5% w/v was generated to support the study. The ratio of test to control lymphocyte proliferation that is greater than 3.0 indicates a positive result. Therefore the positive control test substance was considered to be a sensitizer.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 0.1% resulted in a test/control ratio of 0.89 which is a negative result. Concentration of test material in the vehicle at 1.0 % resulted in a test/control ratio of 0.74 which is a negative result. Concentration of test material in the vehicle at 10 % resulted in a test/control ratio of 1.76 which is a negative result. A test/control ratio of less than 3 was recorded for the three concentrations of the test material (0.1%, 1.0 % and 10 % w/v).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 0.1 % resulted in a mean disintegration of 1061.42 dpm which is a negative result. Concentration of test material in the vehicle at 1 % resulted in a mean disintegration of 657.36 dpm which is a negative result. Concentration of test material in the vehicle at 10 % resulted in a mean disintegration of 2091.46 dpm which is a negative result.
Any other information on results incl. tables
Clinical Observations and Mortality Data: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. Bodyweight changes of the test animals between Day 0 and Day 5 were comparable to those observed in the corresponding control group animals over the same period. No evidence of skin irritation was noted at the treatment site of test or control animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- At all three concentration tested, BMS 296796-02 was not a moderate to strong sensitiser and did not meet the criteria as a sensitizer for classification according to the EU regulations.
- Executive summary:
For a Local Lymph Node Assay the sensitisatoin redsults are determined by the Stimulation Index (SI) which is the ratio of 3HTdR incorporation into the lymph node cells of the test material nodes relative to that recorded for the control nodes. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a non-sensitiser.
The concentration of test material in the vehicle at 0.1% resulted in a stimulation index (SI) of 0.89, the concentration at 1% resulted in a SI of 0.74 and the concentration at 10% resulted in a SI of 1.76. A stimulation index of less than 3 was recorded for all three concentrations of the test material and therefore considered negative results.
The results of this study are considered valid as the key study was assigned a reliability rating of 2, conducted in accordance with GLP and followed an OECD guideline. A stimulation index of less than 3 was recorded for all three concentrations of the test material and was classiffied as a non-sensitiser. Therefore, BMS 296796 -02 did not meet the criteria as a sensitiser for classification according to the EU regulations.
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