Alcohols, C11-15-secondary, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 April 2010 to 19 April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted to draft OECD guidelines and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline For The Testing of Chemicals Draft proposal for a new guideline In Vitro Skin Irritation (OECD2009).

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Test Method B.46 In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, secondary C11-15, ethoxylated

EC Number:

614-295-4

Cas Number:

68131-40-8

Molecular formula:

C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3

IUPAC Name:

Alcohols, secondary C11-15, ethoxylated

Details on test material:

- Name of test material (as cited in study report): Softanol 30
- Physical state: Slightly yellow clear liquid
- Analytical purity: 100%
- Purity test date: Not reported
- Lot/batch No.: 9G28W1
- Expiration date of the lot/batch: 31 July 2010
- Storage condition of test material: Ca. +4°C in the dark

Test animals

Species:

other: EPISKIN human epidermis skin constructs

Strain:

other: not applicable

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium. The positive control was 5% Sodium Dodecyl Sulphate (SDS) in distilled water.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): 100%

Duration of treatment / exposure:

15+/-0.5 minutes

Observation period:

Not applicable

Number of animals:

Not applicable

Details on study design:

See any other information below.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: viability percentage (vs. negative control)

Value:

64.7

Remarks on result:

other:

Remarks:

Basis: mean. Max. score: 100.0. (migrated information)

Any other information on results incl. tables

Table 1 EPISKIN Results

 

Sample	Tissue viability as percentage of mean OD negative control				Prediction MTT endpoint
	Replicate Tissues			Mean ± SD
	a	b	c
Negative Control	112.8	86.3	100.9	100.0 ± 13.3	Not applicable
Positive control	7.5	14.0	6.5	9.3 ± 4.1	Irritant
Softanol 30	51.9	63.8	78.5	64.7 ± 13.3	Non-irritant

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

It was concluded that the test substance, Softanol 30, with a mean tissue viability of 64.7 ± 13.3%, was predicted as a non-irritant to the skin.

Executive summary:

In an Episkin test realised according to the OECD guideline and in compliance with GLP, undiluted Softanol 30was applied for 15 minutes on human epidermis skin constructs and the effect on cell viability was evaluated (HLS 2010, PLZ0016). Appropriate positive and negative controls were used.

 

The tissue viability was 64.7+/-13.3% of the control value, and Softanol 30 was therefore not classified as irritant.