Methyl dodec-9-enoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2011-11-15 to 2011-11-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Read-across from GLP guideline study. Read-across justification: A comparison target substance (9DDAME) and the read-across substance (9DAME) shows that the two substances share structural similarities, increasing from a chain length of C10 to C12 with similar functional groups and also have ‘mechanistic action’ similarities.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In vitro skin irritation: reconstructed human epidermis test method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31

Test material

Test material information

Constituent 1

Reference substance name:

methyl 9-decenoate

EC Number:

662-772-0

Cas Number:

25601-41-6

Molecular formula:

C11H20O2

IUPAC Name:

methyl 9-decenoate

Details on test material:

- Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: clear colourless liquid
- Analytical purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage condition of test material: room temperature in the dark under nitrogen

Test animals

Species:

other: not applicable

Strain:

not specified

Details on test animals or test system and environmental conditions:

The Episkin model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix loaded with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

not specified

Controls:

other: not applicable

Amount / concentration applied:

10 μL

Duration of treatment / exposure:

15 minutes

Observation period:

Not applicable

Number of animals:

Not applicable

Details on study design:

MTT DYE METABOLISM, CELL VIABILITY ASSAY
- The MTT assay is a colourmetric method of determining cell viability based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan dye by mitochondrial succinate dehydrogenase in viable cells.
- One limitation of the assay is possible interference of the test material with MTT. A test item may directly reduce MTT, thus mimicking dehydrogenase activity of the cellular mitochondria. This property of the test item is only a problem if, at the time of the MTT test (after rinsing), there are still sufficient amounts of the test item present on or in the tissues. In this case, the true metabolic MTT reduction and the false direct MTT reduction can be differentiated and quantified.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: relative viability of treated tissues

Value:

68.8

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15 minutes. Remarks: ± 13.7 Percent . (migrated information)

Any other information on results incl. tables

DIRECT MTT REDUCTION

- The MTT solution containing the test item did not turn blue, which indicated that the test material did not directly reduce MTT.

 

TEST MATERIAL, POSITIVE CONTROL AND NEGATIVE CONTROL

- Individual and mean OD540 values, standard deviations and tissue viabilities for the test material, negative control and positive control are shown in Table 1 (attached).

- Mean viabilities and standard deviation of the test material and positive control relative to the negative control are also given in Table 1 (attached).

 

QUALITY CRITERIA

- Relative mean tissue viability for the positive control treated tissues was 4.5 % relative to the negative control treated tissues and the standard deviation value of the percentage viability was 1.4 %. The positive control acceptance criterion was therefore satisfied.

- Mean OD540 for the negative control treated tissues was 0.927 and the standard deviation value of the percentage viability was 8.7 %. The negative control acceptance criterion was therefore satisfied.

- Standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 13.7 %. The test item acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was determined to be non-irritant.