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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the OECD Guideline

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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
EC Number:
284-664-9
EC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
Cas Number:
84961-74-0
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)
- Substance type: technical product (BIO-SOFT 411-E)
- Physical state: viscous liquid
- Analytical purity: 97%
- Lot/batch No.: 50148
- Expiration date of the lot/batch: 30 June 2013
- Storage condition of test material: room temperature in the dark

Test animals

Species:
other: not applicable
Details on test animals or test system and environmental conditions:
Three-dimensional reconstructed human epidermis- EPISKIN model kit purchased from SkinEthic Laboratories (Lyon, France).

Test system

Type of coverage:
other: not applicable
Controls:
other: not applicable
Amount / concentration applied:
15 min
Duration of treatment / exposure:
15 min
Details on study design:
Test MTT reduction by the test material: 10 ul test material + 2 ml 0.3 mg/ml MTT solution incubated for 3 h. The blue colour indicates reduced MTT.

MAIN TEST
DAY 1-Application of test item
Exposure: 15 min
Amount applied: 10 ul
Negative control: 10 ul DPBS
Positive control: 10 ul 5% w/v SDS
Washing: DPBS with Ca++ and Mg++
Post-exposure incubation: 42 h

DAY 3-MTT Loading/Formazan Extraction
Plate shaker: 15 min
MTT solution: 2 ml of 0.3 mg/ml per well
Incubation: 3 h
Biopsy of the epidermis was performed. The tissue was then transfered in micro tubes with 500 ul acidified isopropanol and refrigerated till day 6.

DAY 6-Absorbance/Optical Density
at 540 nm with Anthos 2001 microplate reader

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Remarks:
Relative Mean Viability
Value:
6.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
See below for detailed results.

Any other information on results incl. tables

Table 1: Mean OD540Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item

Item

OD540 of

tissues

Mean OD540

of triplicate

tissues

± SD of

OD540

Relative

individual

tissue

viability (%)

Relative

mean

viability (%)

± SD of

Relative

mean

viability (%)

Negative

Control Item

0.786

0.753

0.029

104.4

100

3.8

0.737

97.9

0.735

97.6

Positive

Control Item

0.129

0.110

0.039

17.1

14.6

5.2

0.065

8.6

0.136

18.1

Test Item

0.032

0.051

0.017

4.2

6.8

2.3

0.055

7.3

0.066

8.8

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this in vitro test benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) is irritanting to the skin.
Executive summary:

The skin irritation potential of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2 -propanamine (1:1) (97%) was examined in this in vitro test withthe EPISKINTMreconstructed human epidermis model. Exposure to the substance lasted 15 minutes and it was followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in the human epidermal cultures following topical exposure to the test item, with the MTT reduction assay.

 

The relative mean viability of the test item treated tissues was 6.8% after the15-Minute exposure period and hence, the test material is a skin irritant. All the quality criteria were satisfied confirming the validity of this test.

 

The study is considered acceptable based on the quality criteria. The test was performed according to the OECD Guidelines for the Testing of Chemicals No. 439 “In Vitro Skin Irritation” (adopted 22 July 2010).