Amines, C12-14-alkyl, C6-10-alkyl phosphates

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: 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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Deviations:

The following deviations from the study plan were observed:
• The pre-test for the ability of direct formazan reduction was not incubated at room
temperature but in the incubation chamber at 3rC and 5% C02. The deviation can
be seen as uncritical since the SOP of MatTek and the SOP of the LAUS GmbH (118
00 820) prescribes it this way (error in study plan).
The deviationwas assessed and signed by the deputy study director on 5. Nov. 2010.
• lnstead of the analytical scales Mettier Toledo AB 184 SA, the analytical scales Mettier
Toledo XS 205 DU were used. The deviation can be seen as uncritical since the
new analytical scales work as precisely as the old analytical scales.
The deviationwas assessed and signed by the deputy study director on 9. Dec. 2010.

Deviations:

yes

Remarks:

The deviation can be seen as uncritical

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-14-alkyl, C6-10-alkyl phosphates

EC Number:

271-663-3

EC Name:

Amines, C12-14-alkyl, C6-10-alkyl phosphates

Cas Number:

68603-55-4

Molecular formula:

not available (UVCB)

IUPAC Name:

Amines, C12-14-alkyl, C6-10-alkyl phosphates

Test material form:

liquid: viscous

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: human-derived epidermal keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

Commercially available Epi-200-Kit. The EpiDerm TM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. lt consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar Iipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The liquid test item was applied without preparation (50 µL).

Duration of treatment / exposure:

three minutes and one hour

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

ca. 114.4

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

ca. 113.4

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test item is considered not corrosive. After three minutes treatment, the relative absorbance values were increased to 114.4%. This value is well above the threshold for corrosivity (50%). After one hour treatment relative absorbance values were increased to 113.4%. This value is well below the threshold for corrosivity (15%). The values of the negative control were well above the required acceptability criterion of mean OD>O.8 for both treatment interval thus showing the quality of the tissues. The value of the positive control induced a decrease in the relative absorbance as compared to the negative control to 30.5% for the three minutes treatment interval and 12.9% for the one hour treatment interval thus ensuring the validity of the test system. For these reasons, the result of the test is considered valid.

Executive summary:

One valid experimentwas performed. Two tissues of the human skin model EpiDerm TM were treated with the test substance for three minutes and one hour, respectively. 50 µL of the liquid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8 m KOH was used as positive control. After treatment with the negative control the absorbance values were weil above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were increased to 114.4 %. This value is weil above the threshold for corrosion potential (50%). After one hour treatment, relative absorbance values were increased to 113.4 %. This value, too, is weil below the threshold for corrosion potential (15%). Therefore, the test substance is considered as not corrosive in the Human Skin Model Test.