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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU Method B.46 (Skin Irritation)
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

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

Resultsopen allclose all
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)
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-SMTM). 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.