Trifluoroacetic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 August 2011 and 16 September 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and Guideline Study. No deviations were observed.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trifluoroacetic anhydride

EC Number:

206-982-9

EC Name:

Trifluoroacetic anhydride

Cas Number:

407-25-0

Molecular formula:

C4F6O3

IUPAC Name:

trifluoroacetic anhydride

Details on test material:

- Name of test material (as cited in study report): TFAH
- Physical state: clear colorless liquid
- Lot/batch No.: BWF10324
- Expiration date of the lot/batch: not supplied
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: at room temperature in the dark, over silica gel and under nitrogen

Test animals

Species:

other: In vitro Corrositex Assay Kit.

Strain:

other: In vitro Corrositex Assay Kit.

Details on test animals or test system and environmental conditions:

Not applicable.

Test system

Type of coverage:

other: In vitro Corrositex Assay Kit.

Preparation of test site:

other: In vitro Corrositex Assay Kit.

Vehicle:

unchanged (no vehicle)

Controls:

other: The negative control, Citric Acid, was prepared as a 10% w/v solution before use. The positive control, Sulphuric Acid, was used as supplied.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500µL

Duration of treatment / exposure:

0 to 3 min
- >3-60 min
- >60-240 min
- >240 min

Observation period:

Until to the test substance break through the membranes.

Number of animals:

Not applicable (in vitro study)

Details on study design:

The purpose of this study was to determine skin corrosion potential of TFAH using the "In Vitro Membrane Barrier Test Method for Skin Corrosion". The results were used to determine the United Nations Package Group. The study was based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.

Protocol:
1- Qualification Screen: the test item was first tested to determine if the sample was compatible with the Corrositex system, therefore 150 µl of TFAH was added to the Qualify test tube. A change in color or consistency was observed.
2- Categorisation Screen: 150 µl of TFAH was added to the categorisation tubes which consist of PH sensitive solutions designed to establish the classification cut-off times. The test tubes were agitated and the color change was observed. The categorisation kit and colour chart provided by in
vitro international were used to determine the category (see Tables 7.3.1/1 and 7.3.1/2)
3- Classification Assay: A membrane disc containing the biobarrier matrix was placed into a chemical detection system (CDS) vial. 500 µl of TFAH was evenly applied onto the top of the membrane disc, and the timer was started. The vials were then observed for a change in the CDS. The positive control (sulphuric acid 95 -98%) and negative control (citric acid 10%) were used (see Table 7.3.1/3). The time it took for the test substance to break through the membranes was documented and the mean value of the breakthrough time for all 4 vials was used in determining the package group (see Tables 7.3.1/1 and 7.3.1/2 .

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: TFAH Category: Category 1

Remarks on result:

other:

Remarks:

Basis: other: based on Corrositex Times. Remarks: The mean breakthrough time of the four test item replicates is 30 seconds (see Table 7.3.1/4).. (migrated information)

In vivo

Irritant / corrosive response data:

TFAH was assigned into Category 1A, the mean breakthrough time of the four test item replicates is 30 seconds. The Corrositex classification is: Corrosive, Packing Group I and CLP category 1A (see Table 7.3.1/4).

Other effects:

Not applicable.

Any other information on results incl. tables

Table 7.3.1/4: The mean breakthrough time of the four test item replicates

				Test Item Breakthrough Time
				Vial 1	Vial 2	Vial 3	Vial 4
Start Time (hr :min :sec)				00 :00 :00	00 :00 :00	00 :00 :00	00 :00 :00
Detection Time (hr :min :sec)				00 :00 :30	00 :00 :30	00 :00 :30	00 :00 :30
Breakthrough Time (hr :min :sec)				00 :00 :30	00 :00 :30	00 :00 :30	00 :00 :30

Table 7.3.1/5: The results of the positive and negative control item

				Chemical	Concentration (weight %)	Breakthrough Time
Positive Control				Sulphuric Acid	95-98%	1 minute
Negative Control				Citric Acid	10%	> 1 hour

 

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, TFAH is classified as corrosive in category 1A, H314, according to the CLP regulation (Regulation EC No. 1272/2008).

Executive summary:

The purpose of this study was to determine skin corrosion potential of TFAH according to the OECD 435 (In vitro Membrane Barrier Test Method for Skin Corrosion). The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system. The results of the assay were used to determine the United Nations corrosive packing group. After the qualification screen and categorisation screen, 500 µl of the test item was evenly applied onto the top of the membrane disc, and the timer was started. The vial was observed for 3 minutes for any change in the CDS. Breakthrough was noted within 3 minutes of application therefore the remaining three discs were treated 1 day later. The vials were observed continuously until breakthrough of the test item had occurred. The first indication of breakthrough of the test item was detected as a change, either in colour or in physical appearance, in the CDS compared to the negative control. The positive (sulphuric acid 95 -98%) and negative (citric acid 10%) control were used and monitored until breakthrough had occured or for 60 minutes. The United Nations Packing Group Classification was determined on the basis of the Corrositex category assigned and mean breakthrough times. TFAH was assigned into Category 1. The mean breakthrough time of TFAH was 30 seconds.

Under the conditions of this test, TFAH is corrosive and is assigned to Packing Group 2. TFAH is classified as corrosif in category 1A,

H314, according to the CLP regulation (1272/2008).