Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 13, 2016 to May 11, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked

EC Number:

806-984-5

Cas Number:

1392411-89-0

IUPAC Name:

Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked

Test material form:

liquid: viscous

Details on test material:

Name: Ebecryl 4738, Batch no.: DR0004393

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: cultured to form a multi-layered, highly differentiated model of the human epidermis

Source strain:

not specified

Justification for test system used:

Validated in vitro model

Vehicle:

unchanged (no vehicle)

Details on test system:

- The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
- Viability: assessed by the MTT test

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

The test substance (pure) was applied directly to each tissue and spread to match the tissue size (0.63 cm2)

Duration of treatment / exposure:

60 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3 replicates

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

MTT test

Value:

2.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the study conditions, the substance was considered to be irritating to skin in the reconstructed human epidermis (RHE) test method.

Executive summary:

A study was conducted to determine the skin irritation potential of the substance according to OECD Guideline 439 (reconstructed human epidermis (RHE) test method), in compliance with GLP. Three tissues of the human skin model EpiDermTM were treated with the test substance for 60 min. The test substance was applied to each tissue and spread to match the tissue size (0.63 cm2). The post incubation period was in total 42 h (at 37 ± 1°C and 5.0 ± 0.5% CO2). DPBS buffer was used as negative control, and 5% SDS solution as positive control. After treatment, the test and the control substance were rinsed off from the tissues. Cell viability of the tissues was then evaluated by the addition of MTT. Viability was evaluated by the enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured (optical density) after extraction from tissues. Values for the negative and positive controls were within the range of historical data, hence the experiment was considered valid. Following exposure with the test substance, cell viability was reduced to 2.5%. Under the study conditions, the substance was considered to be irritating to skin (Andres, 2017).