Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-27 to 2004-02-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 595.12

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate

EC Number:

212-343-5

EC Name:

Methyl N-benzyl-N-(3-methoxy-3-oxopropyl)-β-alaninate

Cas Number:

793-19-1

Molecular formula:

C15H21NO4

IUPAC Name:

methyl 3-[benzyl(3-methoxy-3-oxopropyl)amino]propanoate

Details on test material:

- Name of test material (as cited in study report): T723
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Radiochemical purity (if radiolabelling): No data
- Specific activity (if radiolabelling): No data
- Locations of the label (if radiolabelling): No data
- Expiration date of radiochemical substance (if radiolabelling): No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/ Ca strain of mouse

Sex:

not specified

Details on test animals and environmental conditions:

no data

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

1%, 2.5%, 5%. (v/v)

No. of animals per dose:

4 animals/dose

Details on study design:

RANGE FINDING TESTS: Yes
- Compound solubility: No data
- Irritation: No data
- Lymph node proliferation response: No data

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay in mouse
- Criteria used to consider a positive response: If the ratio of the test substance to control is higher than 3 the substance is a sensitizer.

TREATMENT PREPARATION AND ADMINISTRATION: Prepared as a solution in acetone/olive oil 4:1 at concentrations 1%, 2.5% and 5% v/v. A further group of animails was treated with acetone/olive oil alone.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

other: 2,4-dinitrobenzenesulfonic acid, sodium salt in 1%,10%,20%v/v in 1% pluronic F-68 in distilled water

Statistics:

no data

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

15.38

Test group / Remarks:

1% v/v group, based on results of 4 animals

Results 2

Parameter:

SI

Value:

14.49

Test group / Remarks:

2.5% v/v group, based on results of 4 animals

Results 3

Parameter:

SI

Value:

14.25

Test group / Remarks:

5% v/v group, based on results of 4 animals

Applicant's summary and conclusion

Interpretation of results:

Category 1A (indication of significant skin sensitising potential) based on GHS criteria

Conclusions:

The test material was considered to be a sensitiser under the conditions of the test.