Amides, C8-10, N-(hydroxyethyl)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-04-25 to 2012-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In Vitro Skin Irritation: Human Skin Model Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide

EC Number:

938-458-7

Cas Number:

1443751-77-6

Molecular formula:

UVCB substance: Amides, C8-10 (even-numbered), N-hydroxyethyl

IUPAC Name:

N-(2-hydroxyethyl)decanamide; N-(2-hydroxyethyl)octanamide

Test material form:

solid: flakes

Test animals

Species:

other: reconstructed human epidermis model EpiDerm™ (EPI-200-KIT)

Details on test animals or test system and environmental conditions:

The EpiDerm™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.

Test system

Amount / concentration applied:

Approximately 11 to 13 mg of fine ground test material was applied to the tissues and wetted each with 15 μL deionised water. It was taken care that the test item was evenly distributed on the tissues. For the positive and negative controls 10 μL were dosed per tissue.

Duration of treatment / exposure:

Positive control 15 min (± 1 min) (5% SLS)
Negative control 15 min (± 1 min) Deionised water
Test substance 15 min (± 1 min)

Observation period:

after washing process post incubation period of 42 h

Number of animals:

The test was performed in triplicate

Results and discussion

In vivo

Irritant / corrosive response data:

Test substance: mean viability 5.3 (+/- 0.7) %
Negative control: mean viability 100 (+/- 10.5) %
Positive control: mean viability 20.8 (+/- 1.0) %

Any other information on results incl. tables

Test substance: mean viability 5.3 (+/- 0.7) %

Negative control: mean viability 100 (+/- 10.5) %

Positive control: mean viability 20.8 (+/- 1.0) %

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (in triplicate) resulted in a mean cell viability of 5.3 % when compared to the corresponding negative control. According to the evaluation scheme of OECD test guideline 439 the test substance has to be predicted as irritating to the skin.

Executive summary:

The skin irritating potential of the test substance Amides, C8-10, N-(hydroxyethyl) has been investigated using an in-vitro reconstructed human epidermal model (RHE), according to OECD guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, July 2010).

EpiDerm™ RHEs (EPI-200-KIT) were topically exposed to 11 to 13 mg of fine ground test material for 15 min. The cell viability was determined after an additional 42 h (± 2 h) post incubation period. For the analysis of the tissue viability the Standard MTT Assay was used. The viability of the negative control (Deionised water) was set to 100%.

The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 5.3% (threshold for irritancy: ≤ 50%), consequently the test item was irritant to skin.

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.

The sensitivity and accuracy of the used test system has been demonstrated with the reference substance SLS (5% aqueous solution). A mean cell viability of 20.8 % in relation to the corresponding negative control Deionised water was determined.

 

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test substance Amides, C8-10, N-(hydroxyethyl) is irritant to skin.