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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2012-02-28 to 2012-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Read-across justification is given in the read-across document attached in IUCLID Section 13.

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:
other: EU Method B.46 (Skin Irritation)
Qualifier:
according to
Guideline:
other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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)

In vivo

Irritant / corrosive response data:
if mean tissue viability is > 50% relative to the negative control, the test item is classified as non-irritant (EU CLP and UN GHS: No Category).
if mean tissue viability is <= 50% relative to the negative control, the test item is classified as irritant (EU CLP and UN GHS: Category 2).
Other effects:
The test item showed no direct MTT reducing capability and no colouring potential.

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:
other: non-irritant, EU CLP and UN GHS "No Category"
Remarks:
Criteria used for interpretation of results: other: OECD 439
Conclusions:
The test item is classified as "non-irritant" (No Category).
Executive summary:

The skin irritant potential of the registered UVCB substance (active content 67.9%) was investigated using the EPISKIN-Standard Model (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model as a replacement for the Draize Skin Irritation Test (OECD 404). 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. Irritant potential was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with PBS. The test item Hostapon SG showed no irritant effects. The mean relative tissue viability (% negative control) was>50% (112.1%) after 15 minutes treatment and 42 hour post incubation. The controls confirmed the validity of the study. Hostapon SG therefore classified as non-irritant in accordance with UN GHS and EU CLP "No Category".