Neodecanoic acid, iron salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Remarks:

An Assessment of in vitro Skin Corrosion using EpiDerm™

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental Start Date: 30 August 2017 Experimental Completion Date: 31 August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Method 431 (adopted 29 July 2016) and Method B40 bis of Council Regulation (EC) No 440/2008. An Assessment of in vitro Skin Corrosion using EpiDerm™

Version / remarks:

An Assessment of in vitro Skin Corrosion using EpiDerm™

Deviations:

no

GLP compliance:

yes

Remarks:

The study was conducted in compliance with UK Good Laboratory Practice Regulations 1999, Statutory Instrument 1999 No. 3106; as amended by the Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004, Statutory Instrument 2004 No. 994

Test material

Test material information

Constituent 1

Reference substance name:

Neodecanoic acid, iron salt

EC Number:

257-446-6

EC Name:

Neodecanoic acid, iron salt

Cas Number:

51818-55-4

Molecular formula:

C10H20O2.xFe

IUPAC Name:

λ²-iron(2+) bis(2-ethyl-2,5-dimethylhexanoate)

Test material form:

solid

Details on test material:

CAS Number: 51818-55-4
EC Number 257-446-6
Molecular formula: C30H57FeO6
Molecular weight: 569.6
Purity: 100%
Storage conditions: Refrigerated under Nitrogen ( 2-8 °C )

Specific details on test material used for the study:

Storage 2 to 8°C protected from light, under nitrogen
Batch Number LN11013894
Retest Date 31 July 2019
Purity 100%

In vitro test system

Test system:

human skin model

Remarks:

human skin model, comprising a reconstructed epidermis with a functional stratum corneum

Source species:

other: in vitro skin model EpiDermTM

Details on animal used as source of test system:

Human skin model, comprising a reconstructed epidermis with a functional stratum corneum

Vehicle:

other: The test article was administered without dilution

Control samples:

other: A volume of 50 µL of the undiluted test article was applied to the tissue. Further tissues were concurrently treated with 50 µL distilled water (negative control) and with 50 µL 8N potassium hydroxide (positive control).

Amount/concentration applied:

A volume of 50 µL of the undiluted test article was applied to the tissue. Further tissues were concurrently treated with 50 µL distilled water (negative control) and with 50 µL 8N potassium hydroxide (positive control).

Duration of treatment / exposure:

3 minute or 1-hour contact periods

Duration of post-treatment incubation (if applicable):

incubated for 3 hours (37±1Deg C, 5±1% CO2, 95% RH).
The additional control tissues were incubated with medium instead of MTT solution

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: Skin viability was 86% after three minute and one hour exposures to the test article.

Value:

86

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The OD values for the negative controls met the acceptance criteria, with the exception that the mean OD value for the three minute treatment was just below the range of 0.8 to 2.8 specified in the protocol. However, the result was within the laboratory historical control range of 0.486 to 2.154 and it was considered that the experiment was valid.
Skin viability after the one hour exposure to the positive control article was <15%.
The CV between the replicates should be =30%.

Any other information on results incl. tables

Please see attached OD and Cell Viability Results - Three Minute Exposure Period & OD and Cell Viability Results - One Hour Exposure Period

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article was considered to be non-corrosive according to the UN GHS classification system.

Executive summary:

This study was conducted to determine whether the test article causes corrosion in thein vitro skin model EpiDerm^TM.

Duplicate EpiDerm^TM inserts were treated with test article, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.

Skin viability was 86% after three minute and one hour exposures to the test article.

The OD values for the negative controls met the acceptance criteria, with the exception that the mean OD value for the three minute exposure was just below the range of 0.8 to 2.8 specified in the protocol. However, the result was within the laboratory historical control range of 0.486 to 2.154 and it was considered that the experiment was valid.

Skin viability after a three minute or one hour exposure to the positive control article was 8% and 10%, respectively, demonstrating an acceptable performance of the assay.

The test article was considered to be non-corrosive according to the UN GHS classification system.