Ammonium dodecylbenzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Appears to be valid guideline study, but lack of detail in the information received from data owner

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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., 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:

84961-74-0

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): (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

In vitro test system

Test system:

human skin model

Source species:

human

Vehicle:

not specified

Details on test system:

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.
MAIN TEST : Exposure: 3, 60 and 240 min
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.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

Amount applied: 50 ul
Negative control: 50 ul of 0.9% w/v sodium chloride
Positive control: 50 ul glacial acetic acid

Duration of treatment / exposure:

3, 60 and 240 min

Test system

Amount / concentration applied:

not applicable

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

> 77 - < 85

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

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	240 min	0.169	100
Positive control	240 min	0.024	14.2
Test item	240 min	0.144	85.2
	60 min	0.153	90.5
	3 min	0.131	77.5

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of this in vitro test benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1), is not corosive to the skin.
However, significant effects were observed suggesting likely classification as Skin Irrit 2

Executive summary:

The skin corrosion potential of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (97%) 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 85.2, 90.5 and 77.5 %, after the exposure periods of 240, 60, and 3 minutes, respectively. Therefore, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine is not corrosive to the skin.

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).