Reaction mass of 3-(2-{3-cyanato-5-[2-(3-cyanatoaryl)heteropolycycle-5-yl]aryl}heteropolycycle-5-yl)aryl cyanate and heteropolycycle -2,5-diyldi-3,1-arylene dicyanate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 May 2011 - 15 November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 439

Deviations:

no

Principles of method if other than guideline:

The objective of this study was to assess the skin irritation potential, in vitro, of the test substance. The test was conducted in accordance with the Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM) and the OECD 439 Guideline For The Testing of Chemicals: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD439).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

LZ1554

IUPAC Name:

LZ1554

Details on test material:

- Name of test material (as cited in study report): LZ1554
- Physical state: Highly viscous brownish liquid
- Expiration date of the lot/batch: 15 July 2012
- Storage condition of test material: Room temperature in the dark, under nitrogen

Test animals

Species:

other:

Strain:

other:

Test system

Controls:

not required

Amount / concentration applied:

The positive and negative controls were in liquid form and were applied by dispensing a volume of 10 μl over each tissue using a positive displacement pipette. A weight of 10 ±2 mg of the test substance, LZ1554, a highly viscous brownish liquid, was applied to the tissue using the curved edge of a spatula. In order to spread 10 ±2 mg, a higher amount of 12 ±2 mg was weighed to compensate for some of the substance sticking to the spatula.

Duration of treatment / exposure:

After incubation of at least 24 hours in maintenance medium, triplicate tissues were dosed for 15 minutes with the test substance, negative or positive control at room temperature. A maximum of four samples were applied in a block with a minimum of 1 minute intervals between each application of substance. On application of 10 μl, the positive control was spread over the tissue for approximately 30 seconds and then respread with a curved flat spatula after approximately 7 minutes application time.
After 15 minutes, each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance. The surface of the tissues treated with the test substance, LZ1554, were also gently swabbed to remove residual test material. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a well containing 2 ml maintenance medium and incubated for 42 ± 1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 ml of 0.3 mg/ml MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.

Observation period:

At the end of 3 hours ± 5 minutes, the triplicate inserts were blotted on absorbent paper. The epidermis was removed from the insert using a biopsy punch, the epidermis separated from the collagen matrix using forceps and both parts placed in a micro tube. When all tissues had been punched, the tissues were vortexed with 500 El of acidic isopropanol (0.04 N HCl final concentration).
The tissues were extracted by storing at 2-8 ºC, protected from light, for 70 hours.

Number of animals:

No animals were used as the method carried out was an in-vitro method.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: tissue viabiity

Value:

107.8

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 42 hours. Max. score: 111.9. (migrated information)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.

Executive summary:

The skin irritation/corrosion potential was determined in a GLP-compliant study in accordance with OECD guideline no. 439 (EPISKIN method). It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.