Stearamide

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

Principles of method if other than guideline:

EPISKIN reconstituted human epidermis model: 15 min treatment followed by 42 hours post-exposure incubation period.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C16-C18 (even numbered)

Molecular formula:

not available, UVCB

IUPAC Name:

Amides, C16-C18 (even numbered)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Crodamide SR
- Physical state: off white powder (1.0 Gardner)
- Analytical purity: 98.21%
- Composition of test material, percentage of components: 0.05% moisture
- Purity test date: 19 January 2010
- Lot/batch No.: BIN#01
- Expiration date of the lot/batch: 19 January 2011
- Storage condition of test material: room temperature in the dark
- Other: Date of manufacture 07 December 2001

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: reconstituted human epidermis

Cell source:

other: adult human-derived epidermal keratinocytes

Source strain:

other: not applicable

Vehicle:

unchanged (no vehicle)

Details on test system:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 15 min

SCORING SYSTEM: not applicable, measurement of cytotoxicity by colourimetric MTT reduction assay

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ± 2 mg

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

42 hours post-exposure incubation period

Number of replicates:

triplicate tissues

Test system

Vehicle:

unchanged (no vehicle)

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

Test substance

Run / experiment:

mean of 3 runs

Value:

117.4

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

Negative control

Run / experiment:

mean of 3 runs

Value:

100

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Results 3

Irritation / corrosion parameter:

% tissue viability

Remarks:

Positive control

Run / experiment:

mean of 3 runs

Value:

7.3

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Other effects / acceptance of results:

The test material was considered to be Non-Irritant (NI).

Any other information on results incl. tables

The test material did not directly reduce MTT.

Mean OD540 values and percentage viabilities for the negative control material, positive control material and test material:

Material	OD540of tissues	Mean OD540if triplicate tissues	± SD of OD540	Relative individual tissue viability (%)	Relative mean viability (%)	± SD of Relative mean viability (%)
Negative control	0.784	0.834	0.045	94.0	100*	5.4
	0.847			101.6
	0.871			104.4
Positive control	0.069	0.061	0.016	8.3	7.3	1.9
	0.071			8.5
	0.043			5.2
Test material	1.079	0.979	0.087	129.4	117.4	10.4
	0.925			110.9
	0.933			111.9

* The mean viability of the negative control tissues is set at 100%

The relative mean viability of the test material treated tissues was 119.2% after a 15 -minute exposure, the test material treated tissues appeared blue which was considered indicative of viable tissue.

The relative mean tissue viability for the positive control treated tissues was ≤ 40% relativ to the negative control, and the standard deviation value of the percentage viability was ≤20%. The positive control acceptance criterion was therefore satisfied.

The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the percentage viability was ≤20%. The negative control acceptance criterion was therefore satisfied.

Conclusion:

The test material was considered to be Non-Irritant (NI).

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified