Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-28 to 2012-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium cocoyl glycinate (SCG) [INCI]

IUPAC Name:

Sodium cocoyl glycinate (SCG) [INCI]

Details on test material:

Chemical name: Glycine, N-coco acyl derivs., sodium salts

Test animals

Species:

other: EpiSkin reconstructed human epidermis model

Strain:

not specified

Details on test animals or test system and environmental conditions:

organotypic reconstructed three-dimensional model of the human epidermis

Test system

Type of coverage:

other: direct application

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

other: negative control: 10µl PBS; positive control: 10µl 5% SDS

Amount / concentration applied:

10 mg + 5 µL aqua dest.

Duration of treatment / exposure:

15 minutes

Observation period:

42 +/- 1 h

Number of animals:

three replicate tissues per dose group

Details on study design:

3 replicate tissues are dosed with the test item, the negative control (PBS) and the positive control (5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. The isopropanol extracts are measured photometrically at 550 nm.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

> 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: non-irritant EU CLP and UN GHS: No Category. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

<= 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: irritant EU CLP and UN GHS Category 2. (migrated information)

Any other information on results incl. tables

 

Name	Negative Control			Positive Control			Test Item
Tissue	1	2	3	1	2	3	1	2	3
absolute OD550	1.325	1.338	1.225	0.144	0.135	0.138	1.471	1.394	1.475
	1.260	1.311	1.196	0.143	0.131	0.144	1.408	1.386	1.418
blank-corrected OD550	1.282	1.295	1.182	0.102	0.092	0.095	1.428	1.351	1.432
	1.217	1.268	1.153	0.100	0.089	0.101	1.365	1.343	1.375
mean OD550of the duplicates (blank-corrected)	1.250	1.282	1.168	0.101	0.090	0.098	1.397	1.347	1.404
total mean OD550of 3 replicate tissues (blank-corrected)	1.233^*			0.096			1.383
SD OD550	0.06			0.01			0.04
relative tissue viabilities [%]	101.4	103.9	94.7	8.2	7.3	8.0	113.3	109.3	113.8
mean tissue viability [%]	100.0			7.8^**			112.1
SD tissue viability [%]^***	4.8			0.4			2.5
CV [% viability]	4.8			5.6			2.2

^*          Corrected mean OD₅₅₀of the negative control corresponds to 100% absolute tissue viability.

^**      mean relative tissue viability of the three positive control tissues is£ 40%

^***     the standard deviation (SD) obtained from the three concurrently tested tissues is < 18%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Hostapon SG (70% N-cocoyl glycinate) is not irritating to skin

Executive summary:

The skin irritant potential of the Hostapon SG (70% N-cocoyl glycinate) was investigated using the EPISKIN-Standard Model (EPISKIN-SM^TM). The test compound was applied topically to the EPISKIN-SM tissue for 15 minutes followed by a 42 hour post incubation period and immediate determination of cytotoxic effects via MTT reduction assay. No significant effect was found. Hostapon SG is not skin irritating.