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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:
2012
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 of the read across substance (9DAME) and the target substance (ODDAME) shows that the two substances share structural similarities, increasing from a chain length of C10 to C18 with similar functional groups. See attahced for 'read across jusification' for ODDAME.

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)

Test material

Constituent 1
Reference substance name:
9-Decenoic acid, methyl ester
IUPAC Name:
9-Decenoic acid, methyl ester
Constituent 2
Reference substance name:
25601-41-6
Cas Number:
25601-41-6
IUPAC Name:
25601-41-6
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

In vitro test system

Test system:
human skin model
Justification for test system used:
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.
Vehicle:
unchanged (no vehicle)
Details on test system:
See any other information on materials and methods section.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 μL
Duration of treatment / exposure:
15 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3

Test system

Vehicle:
not specified

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: relative viability of treated tissues
Run / experiment:
Mean
Value:
68.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 minutes. Remarks: ± 13.7 Percent .

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.

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