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EC number: 700-361-0 | CAS number: 361442-00-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 2 002
- Report date:
- 2002
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 substance name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- EC Number:
- 700-361-0
- Cas Number:
- 361442-00-4
- Molecular formula:
- C17H27NO5
- IUPAC Name:
- (2S)-2-{[(tert-butoxy)carbonyl]amino}-2-(3-hydroxyadamantan-1-yl)acetic acid
- Reference substance name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- IUPAC Name:
- 1-Hydroxyadamantanyl-3-(S)-Boc-glycine
- Details on test material:
- white powder; stored at room temperature in the dark; received at testing laboratory on May 7, 2002.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: Crl: CBA/Ca Cru,BR
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: eight to nine weeks old on day 1
- Weight at study initiation: weight range of 15 to 19 grams
- Housing: Up to four female mice were accommodated in suspended polypropylene cages with solid floors and wire mesh lids. Fresh wood flakes were provided as floor litter and this was changed twice weekly.
- Diet (e.g. ad libitum): Free access to mains drinking water and food was allowed throughout the study.
- Water (e.g. ad libitum):Free access to mains drinking water and food was allowed throughout the study.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 C
- Humidity (%): 40 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hours/12 hours
IN-LIFE DATES: From: July 16th To:July 23rd, 2002
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Treated with 0.025 ml per ear (pinna) (0.05 mL both ears) of the test solution in dimethyl formamide at concentrations of 10%, 25% and 50% w/w.
- 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 1 % m/v Dimethylformamide alone.
- Details on study design:
- The 3 groups were treated for three days with the test formulation by using a glass syringe to the dorsal surface of each ear. All animals were observed on Day 0, 1, and 2. On Day 6 all mice were placed under an infrared lamp to improve IV dosing and were injected with 0.250 ml of a phosphate buffered saline solution containing tritiated thymidine to the tail vein giving a total of 20 uCi to each mouse. 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 tritiated thymidine all mice were killed by halothane asphyxiation and their auricular lymph nodes were excised and pooled for each experimental group. A 5 ml of phosphate buffered saline was added to each set of lymph nodes.The lymph nodes collected into each petri dish were cut open and disaggregated by squashing the fragments with a sharp blade. The resultant liquor was collected into a code-identified conical tube. The petri dish was rinsed with an additional 5 mL phosphate buffered saline and the second liquor was added to the first liquor. At each washing, debris such as connective tissue or fragments of capsule were retained in the petri dish if possible. The pooled liquor was taken off any sediment five minutes after the two liquors had been mixed, placed in a syringe and pushed through a fine mesh in to a conical centrifuge tube to further remove any debris. The liquor was centrifuged at 190 G for 10 minutes. After disposal of the supernatant the pellet was resuspended in 5 mL phosphate buffered saline. This liquor was also centrifuged at 190 G for ten minutes prior to disposal of the supernatant and re-suspension of the pellets in 5% m/v aqueous trichloroacetic acid. These suspensions were stored overnight at approximately 5°C.
On the following day the suspensions were re-centrifuged at 190 G for 10 minutes and the supernatant was drawn off. The pellets were resuspended in 1 mL 5% m/v aqueous trichloroacetic acid. This preparation was subject to ultrasonic dispersion for 25 minutes to ensure a thoroughly dispersed suspension. Prepared suspensions (1 mL) were added to code-identified scintillation pots containing 9 mL Optiphase "Hisafe" scintillation fluid and were mixed by agitation with a Pasteur pipette. Once prepared the scintillation pots were placed in the appropriate carrier racks with an Optiphase blank sample and an Optiphase/5% m/v aqueous trichloroacetic acid (9:1 by volume) blank. The carrier rack was passed into the scintillation counter (Tricarb 2100TR). This operated on a program specific to tritiated samples. The counting period was ten minutes.
Determination of the tritiated thymidine incorporation was completed by measuring radioactive disintegration for each experimental group lymph node cells by using a beta-scintillation counter. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data indicated
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Results reported as proliferation index (PI) which is equivalent to a simulation index (SI). Results reported as proliferation index (PI). Concentration of test material the vehicle at 10 % resulted in a proliferation index (PI) of 2.0 which is a negative result. Concentration of test material in the vehicle at 25 % resulted in a proliferation index (PI) of 1.1 which is a negative result. Concentration of test material in the vehicle at 50 % resulted in a proliferation index (PI) of 2.4 which is a negative result.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Results reported as counts per minute (cpm) which is equivalent to a disintegration per minute (DPM) Results reported as . per minute (cpm) Concentration of test material in the vehicle at 10 % resulted in a mean disintegration of 1405.08 cpm. Concentration of test material in the vehicle at 25 % resulted in a mean disintegration of 806.49 cpm. Concentration of test material in the vehicle at 50 % resulted in a mean disintegration of 1703.35 cpm.
Any other information on results incl. tables
Sample identity |
Number of sites yielding lymph nodes |
Counts per minute* (CPM) |
Counts per minute per node (CLM) |
Proliferation Index (PI) |
Scintillation fluid (blank) |
|
17.34 |
|
|
Scintillation fluid with 5% m/v trichloroacetic acid |
|
104.98 |
|
|
Vehicle control (dimethylformamide) |
8 |
714.4 |
89.30 |
|
BMS 528233-01, 10% m/v |
8 |
1405.08 |
175.64 |
2.0 |
BMS 528233-01, 25% m/v |
8 |
806.49 |
100.81 |
1.1 |
BMS 528233-01, 50% m/v |
8 |
1703.35 |
212.92 |
2.4 |
* All scintillation counts corrected for the blank (except for Scintillation Fluid sample itself)
PI =Test group CLM value
Control group CLM value
TABLE 2 Body weights
Group |
Animal |
Body weights (g) |
|
Number |
number |
Day -1 |
Day 6 |
1 |
1 2 3 4 |
16 19 18 16 |
17 18 19 19 |
2 |
5 6 7 8 |
15 17 18 17 |
17 18 19 18 |
3 |
9 10 11 12 |
17 18 18 17 |
18 20 19 19 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The Local Lymph Node Assay demonstrated that BMS 528233-01 does not have the potential to cause skin sensitisation.
- Executive summary:
This study was conducted to assess the potential of BMS 528233-01 to cause skin sensitisation in the mouse. The test article was prepared for administration at 10, 25 or 50% m/v in a solution dimethylformamide. Groups of four female CBA mice were subjected to topical applications of vehicle or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated thymidine was injected intravenously into each mouse. Five hours later the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% m/v trichloroacetic acid and processed through a scintillation counter.
Test results are expressed in terms of Proliferation Indices; the ratio of the scintillation count per lymph node obtained from a test group relative to the corresponding scintillation count from controls. The threshold level for the Proliferation Index to be considered a positive indicator of moderate to severe potential to cause skin sensitisation is 3.0.
Concentration of test article in applied formulation (%m/v)
10%
25%
50%
Proliferation Index
2.0
1.1
2.4
The Local Lymph Node Assay demonstrated that BMS 528233-01 does not have the potential to cause skin sensitisation.
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