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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 September 2013 - 27 September 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: PREPOLYMER D
Chemical Name: Reaction mass of Bis (2-chloroethoxy)methane and 1,15-dichloro-3,5,8,11,13-pentaoxa-pentadecane and 1-(2-chloroethoxy)-2-(2-chloroethoxymethoxy)ethane
Batch/Lot Number: 030613
Purity: 100% (multi constituent substance)
Appearance: slightly brownish liquid

Test animals

Species:
human
Strain:
other: EPISKIN-SM

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: cell viability
Run / experiment:
mean
Value:
105
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: The OD value for the test item treated skin showed a viability of 105%.. (migrated information)
Other effects / acceptance of results:
For results of the optical density (OD) measured at 540 nm of each extract and the calculated % viability of the cells see attached table.
Colouring potential of test substances
As the test item is coloured, one additional test item-treated tissue was used for the non specific OD evaluation. Optical density (measured at 540 nm) of this tissue was determined as 0.034, Non Specific Colour % was calculated as 4.7%. Therefore additional data calculation was not necessary.

No colour change was observed after three hours of incubation of the test item in MTT solution. The test material did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability can be precluded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following exposure with PREPOLYMER D, the mean cell viability was 105% compared to the negative control and therefore non-irritant. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
In this in vitro skin irritation test in the EPISKIN model with PREPOLYMER D the results indicated that the test item is Non Irritant (NI).
Executive summary:

The reconstructed human epidermis model EPISKIN-SM is designed to predict and classify the skin irritant potential of chemicals, by measuring its cytotoxic effect, as reflected in the MTT assay, on the EPISKIN reconstituted human epidermis. This method is approved by international regulatory agencies as a replacement for the identification of irritants / corrosives in the in vivo Rabbit skin assay (OECD 404).

Disks of EPISKIN (three units / chemical) were treated with PREPOLYMER D and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS. Epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of the epidermis on each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan extract in acidified isopropanol was then spectrophotometrically evaluated for optical density (OD) and quantified.

SDS 5% and PBS treated epidermis were used as positive and negative controls, respectively. An additional disk was used to provide an estimate of colour contribution from the test item. For each treated tissue viability was expressed as a % relative to negative control. If the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test substance is considered to be irritant to skin.

Following exposure with PREPOLYMER D, the mean cell viability was 105% compared to the negative control and therefore non- irritant. All validity criteria were within acceptable limits and therefore the study can be considered as valid.

In this in vitro skin irritation test in the EPISKIN model with PREPOLYMER D the results indicated that the test item is Non Irritant (NI).