Registration Dossier
Registration Dossier
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EC number: 610-954-5 | CAS number: 53075-09-5
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Principles of method if other than guideline:
- The test method is used to evaluate the cytotoxicity of the test substance using the Balb/c 3T3 Neutral Red Uptake (NRU) in vitro cytotoxicity test after 48 hours exposure (ICCVAM Test Method Evaluation Report, No. 07-4519, NIEHS 2006). Based on the results of this ICCVAM Validation Study the data are used to predict the starting dose for rodent acute oral systemic toxicity assays (LD50).
- Type of method:
- in vitro
- Endpoint addressed:
- acute toxicity: oral
Test material
- Reference substance name:
- Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, hydroxide (1:1)
- EC Number:
- 610-954-5
- Cas Number:
- 53075-09-5
- Molecular formula:
- C13 H25 N O
- IUPAC Name:
- Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, hydroxide (1:1)
- Details on test material:
- - Name of test substance: Adamantyltrimethylammoniumhydroxid 20%
- Batch identification: aus Verkaufsprodukt 2008-1a
- CAS No.: 53075-09-5
- Purity/composition: 20% in water
- Date of production: 10 Mar 2008
- Molecular weight: 211.3 g/mol
- Physical state, appearance: Liquid, colorless, clear
- Storage eonditions: Room temperature, under N2
Constituent 1
Test animals
- Species:
- other: in vitro study
- Strain:
- other: Balb/c 3T3 cells
Administration / exposure
- Route of administration:
- other: in culture medium
- Vehicle:
- other: culture medium
- Duration of treatment / exposure:
- 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.0, 46.4, 100.0, 215.4, 464.2, 1000.0, 2154.4, 4641.6, 10000 µg/ml
Basis:
nominal conc.
Results and discussion
- Details on results:
- Interpolated IC50 value (µg/mL): 1976
Any other information on results incl. tables
Calculated data:
Conc. (µg/ml) |
0.0 |
48.4 |
100.0 |
215.4 |
464.2 |
1000.0 |
2154.4 |
4641.6 |
10000 |
Mean corrected OD: SD: |
0.280 0.035 |
0.271 0.005 |
0.267 0.010 |
0.259 0.011 |
0.210 0.012 |
0.174 0.008 |
0.134 0.007 |
0.071 0.005 |
0.008 0.001 |
Relative Toxicity: SD: |
100.0% 12.64% |
96.6% 1.77% |
95.5% 3.65% |
92.4% 4.17% |
75.0% 5.92% |
62.0% 4.55% |
47.8% 5.47% |
25.2% 6.62% |
2.7% 18.40% |
OD: optical density; SD: standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpolated IC50 value (µg/mL): 1976
Interpolated LD50 (mg/kg body weight): 1778
Predicted Starting Dose (mg/kg body weight): 2000
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