Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol

EC Number:

939-479-4

Molecular formula:

not applicable, UVCB

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol

Test material form:

other: viscous liquid

Details on test material:

- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) (in 1,2-propylene glycol)
- Name of product (as cited on Certificate of Analysis): MARLON AMI 80
- Substance type: technical product
- Physical state: yellow-brown viscous liquid
- Analytical purity: 78% w/w benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol
- Lot No.: 126
- Expiration date of the lot: 01 June 2013
- Storage condition of test material: room temperature in the dark
- Other: data not verified by the laboratory; identity details were supplied by the Sponsor

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 (Nice, France).

Test system

Type of coverage:

other: not applicable

Controls:

other: not applicable

Amount / concentration applied:

not applicable

Duration of treatment / exposure:

3, 60 and 240 min

Details on study design:

Pre-test: Test MTT reduction by the test material: 50 ul test material + 2.2 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: 3, 60 and 240 min
Amount applied: 50 ul
Negative control: 50 ul of 0.9% w/v sodium chloride
Positive control: 50 ul glacial acetic acid
Washing: PBS with Ca++ and Mg++
MTT solution was applied: 2.2 ml of 0.3 mg/ml per well, incubation followed for 3 h ± 5 min
Biopsy of the epidermis was performed. The tissue was then transfered in micro tubes with 850 ul acidified isopropanol.

DAY 2-Absorbance/Optical Density
at 540 nm with Anthos 2001 microplate reader

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

240 minutes

Value:

66.5

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minutes

Value:

83.8

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minnutes

Value:

87.9

Any other information on results incl. tables

Table 1: Mean OD540 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item

Item	Exposure Period	Mean OD540 of duplicate tissues	Relative mean viability (%)
Negative Control Item	240 min	0.173	100
Positive Control Item	240 min	0.033	19.1
Test Item	240 min	0.115	66.5
	60 min	0.145	83.8
	3 min	0.152	87.9

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this in vitro test MARLON AMI 80, and hence benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1), are not corosive to the skin.

Executive summary:

The skin corrosion potential of MARLON AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in  1,2-propylene glycol) was examined in this in vitro test with the EPISKIN^TMreconstructed human epidermis model. Exposure to the substance lasted 3, 60, and 240 minutes.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 66.5, 83.8 and 87.9%, after the exposure periods of 240 60, and 3 minutes, respectively. Therefore, MARLON AMI 80 is not corrosive to the skin. Based on this result, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) shall not be considered as skin corrosive.

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. 431 “In VitroSkin Corrosion” (adopted April 2004).