Reaction mass of 2,2',2''-nitrilotriethanol and disodium succinate and sodium acetate and sodium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-10-21 to 2012-11-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to OECD TG 431 (2004) and under GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of CXN1-55

IUPAC Name:

Reaction mass of CXN1-55

Details on test material:

- Name of test material (as cited in study report): Reaction mass of CXN1-55- Substance type: multi-constituent substance- Physical state: Paste- Stability under test conditions: substance considered stable under normal ambient conditions- Storage condition of test material: at room temperature at 20 ± 5 °C, in the dark.

Test animals

Species:

other: EpiDerm™ tissues model

Strain:

other: EpiDerm™

Details on test animals or test system and environmental conditions:

EXPERIMENTAL DETAILS- Source: Epi-200 kits and MTT-100 assays were purchased from MatTek Corporation (Ashland, MA 01721, USA).- Age at study initiation: EpiDerm™ tissues were shipped at 4 °C on medium-supplemented agarose gels in a 24- well plate on October 23, 2012. After receipt of the EpiDermTM tissues before starting the assay, the tissues were transferred to 6-well plates with assay medium, which was immediately replaced before the test is started. Test start was October 24, 2012. At least 1 hour before dosing, EpiDerm™ tissues were removed from the refrigerator. Under sterile conditions using sterile forceps, the inserts were transferred into 6-well plates containing the pre-warmed assay medium. A 2 -well plate was prepared as holding plate containing 300 μL assay medium. The holding plate was pre warmed in an incubator (37 ± 1.5 °C, 5 ± 0.5 % CO2) until use.- Acclimation period: 1 dayENVIRONMENTAL CONDITIONS- Temperature (°C): 37 ± 1.5 °C- Humidity (%): not applicable for this in vitro test- Air changes (per hr): not applicable for this in vitro test- Photoperiod (hrs dark / hrs light): not applicable for this in vitro test- CO2 concentration (%): 5 ± 0.5 % CO2IN-LIFE DATES: 2012-10-24 to 2012-10-25

Test system

Type of coverage:

other: EpiDerm™ tissues model

Preparation of test site:

other: EpiDerm™ tissues model

Vehicle:

unchanged (no vehicle)

Controls:

other: EpiDerm™ tissues treated with water

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): Each approximately 25 – 28 mg of the test item was applied to each tissue, wetted with 50 μL of deionised water, and spread evenly to the surface- Concentration: 25-28 mg/0.050 mL = 500-560 g/LVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle

Duration of treatment / exposure:

3 minutes and 1 hour

Observation period:

after exposure period 3 hour inmcubation period in MTT-solution (MTT=(3-4,5-dimethyl thiazol 2-yl) 2,5-diphenyl-tetrazolium bromide) rinsing with DBPS (Dulbecco's Phosphate Buffered Saline) immersing within isopropanole transfering to blue formazan solution

Number of animals:

Duplicates of EpiDerm™ tissues were exposed to the test item, positive or negative control for each of two different exposure periods: 3 minutes and 1 hour.

Details on study design:

TEST SITE- Area of exposure: EpiDerm™ tissues- % coverage: 100 %REMOVAL OF TEST SUBSTANCE- Washing (if done): yes- Time after start of exposure: 3 minutes or 1 hourSCORING SYSTEM: determination of optical density

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: corrosion of EpiDerm™ tissues models

Basis:

other: relative absorbance value

Time point:

other: exposure of 3 minutes

Score:

> 50

Reversibility:

other: viability

Results 2

Irritation parameter:

other: corrosion of EpiDerm™ tissues models

Basis:

other: relative absorbance value

Time point:

other: exposure of 1 hour

Score:

> 15

Reversibility:

other: viability

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationnon corrosiveCriteria used for interpretation of results: other: EU CLP and UN GHS

Conclusions:

In this valid, reliable and conclusive study according to OECD TG 431 and under the reported experimental conditions, the test item Reaction mass of CXN1-55 was non corrosive to skin according to EU CLP and UN GHS.

Executive summary:

This valid, reliable and conclusive in vitro study was performed to assess the corrosive potential of Reaction mass of CXN1-55 by means of the Human Skin Model Test with EpiDerm™ tissues models according to OECD TG 431.

Independent duplicate tissues of EpiDermTM were exposed to either the test item Reaction mass of CXN1-55 (each approximately 25 – 28 mg, each wetted with 50 μL of deionised water, and spread evenly to the surface), the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively.

After exposure to the negative control the absorbance values met the required acceptability criterion of mean OD570 ≥ 0.8 for both treatment intervals thereby confirming the acceptable quality of the tissues.

Exposure to the positive control induced a decrease in the relative absorbance compared to the negative control, both for the 3 minutes exposure period (22.9 %) and for the 1 hour exposure period (9.4 %) thus confirming the validity of the test system and the specific batch of tissue models.

After exposure to the test item Reaction mass of CXN1-55 the relative absorbance value did not decrease at all after 3 minutes exposure (104.9 %). After 1 hour exposure the relative absorbance value was reduced to 87.3 %. Both values did not exceed the threshold for corrosivity which is defined to be 50 % after the 3 minutes exposure and 15 % after the 1 hour exposure. Therefore, the test item was not considered to be corrosive.