Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione

EC Number:

272-782-3

EC Name:

Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione

Cas Number:

68911-68-2

Molecular formula:

N/A

IUPAC Name:

C12-14-tert-alkylamines, compds. with 2(3H)-benzothiazolethione

Test material form:

liquid

Specific details on test material used for the study:

Not specified.

In vitro test system

Test system:

artificial membrane barrier model

Source species:

other: Artificial barrier

Cell type:

other:

Cell source:

other: Not specified

Source strain:

other: Not applicable

Vehicle:

unchanged (no vehicle)

Details on test system:

A qualification test was performed to insure the test sample and the test reagent are compatible.

The second step of the Corrositex test utilizes appropriate indicator solutions to permit categorization of the test sample as either a Corrositex Category 1 or Corrositex Category 2 material. Corrositex Category 1 materials are typically strong acids/bases, while Corrositex Category 2 materials are typically weak acids/bases.

The third step in the test is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the reagent which then undergoes a simple color change. This color change is visually observed and the time required for the color change to occur is recorded.

Control samples:

no

Amount/concentration applied:

150 µL

Duration of treatment / exposure:

0 to 3 minutes, >3 to 60 minutes, >60 to 240 minutes, and >240 minutes.

Duration of post-treatment incubation (if applicable):

Not applicable

Number of replicates:

4

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

penetration time (in minutes)

Run / experiment:

1, 2, 3, and 4

Value:

> 60

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

other: Not corrosive

Any other information on results incl. tables

Summary of Corrositex^®Test Results

Replicate	Corrositex Time (minutes)
1	>60
2	>60
3	>60
4	>60
Mean	>60

 

Additional Test Information:

- Concentration of test material tested: Neat

- pH(10%) : 8.45

- Corrositex Category: 2

- UN Packing Group: Non-corrosive

- GHS Skin Corrosion Category: Not Category 1

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of the study, the test material has been determined not to be corrosive.

Executive summary:

The study has been performed to the standardised guideline OECD 435. However, no statement of GLP has been made. The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of >60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of the test material as a UN Non-corrosive and not a GHS Category 1.