Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012 - 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study in accordance with EU method B.40.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

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:

equivalent or similar 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:

Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts

EC Number:

938-445-6

Molecular formula:

C16H37NO4S - C34H72NO12S

IUPAC Name:

Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Physical state: solid
- Lot/Batch No. PU20740016, PU20740019
- Expiration date of lot/batch: 14/03/2014
- Storage condition of test materilal: common room light, room temperature

Specific details on test material used for the study:

- Name of test material (as cited in study report): DE07_2012_001_PLSW
- Substance type: Alkylsulfate/alkylethersulfate
- Chemical name: Alcohols, C16-18 (even numbered, C18-unsatd.), ethoxylated, and alcohols C20-22 (even numbered), sulfates, ammonium salts
- CAS: n/a
- Physical state: ivory paste-like solid at 20 °C
- Batch No.: PU20740016, PU20740019
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

water

Test system

Type of coverage:

occlusive

Preparation of test site:

other: EpiDermTM

Vehicle:

water

Amount / concentration applied:

approx. 25 mg + 15 μL H2O

Duration of treatment / exposure:

3 min and 60 min experiments
3 h postincubation period

Details on study design:

This in vitro method is designed to predict and classify the skin corrosivity potential of a chemical by assessment of its effect on EpiDerm, a
reconstituted three-dimensional human epidermis model. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min. and 60 min. exposure period. The EpiDerm Skin Model is a well established organotypic, threedimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin. This in vitromethod allows the identification of corrosive chemical substances and mixtures. It further allows the identification of noncorrosive substances and mixtures when supported by a weight of evidence determination using non-animal methods.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

negative control

Value:

100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

3 min exposure and 3 h of post-incubation

Results 2

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

positive control

Value:

12

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

3 min exposure and 3 h of post-incubation

Results 3

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

test item

Value:

92

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

3 min exposure and 3 h of post-incubation

Results 4

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

negative control

Value:

100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

60 min exposure and 3 h of post-incubation

Results 5

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

positive control

Value:

10

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

60 min exposure and 3 h of post-incubation

Results 6

Irritation / corrosion parameter:

% tissue viability

Remarks:

3 tissues per dose group

Run / experiment:

test item

Value:

100

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

60 min exposure and 3 h of post-incubation

In vivo

Irritant / corrosive response data:

not applicable

Any other information on results incl. tables

Pre-Experiment:

The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. The mixture of 25 mg test item per 300 μL A. dest. showed no colouring as compared to the solvent.

Experiment:

3 min:

Total mean OD550 of 2 replicate tissues (blank-corrected)

Negative Control: 2.667

Positive Control: 0.330

Test Item: 2.463

SD (OD550)

Negative Control: 0.300 / 0.028

Positive Control: 0.007 / 0.004

Test Item: 0.030 / 0.036

Mean relative tissue viabilities [%]

Negative Control

100

Positive Control

12

Test Item

92

60 min:

Total mean OD550 of 2 replicate tissues (blank-corrected)

Negative Control: 2.671

Positive Control: 0.259

Test Item: 2.667

SD OD550

Negative Control: 0.498 / 0.036

Positive Control: 0.005 / 0.003

Test Item: 0.105 / 0.038

Mean relative tissue viabilities [%]

Negative Control

100

Positive Control

10

Test Item

100

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.

Executive summary:

The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 3 min. and 60 min. followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods compared to the corresponding negative control tissues concurrently treated with dest. water. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (92%) after 3 min. treatment and >= 15% (100%) after 60 min. treatment.