Registration Dossier

Diss Factsheets

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:
2008
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

Constituent 1
Chemical structure
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

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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