Perrhenic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th-14th May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Perrhenic acid

EC Number:

237-380-4

EC Name:

Perrhenic acid

Cas Number:

13768-11-1

Molecular formula:

H.O4Re

IUPAC Name:

rheniumoylol

Constituent 2

Reference substance name:

Perrhenic acid solution

IUPAC Name:

Perrhenic acid solution

Test material form:

other: Solution

Details on test material:

- Name of test material (as cited in study report): Perrhenic acid, solution.
- Physical state: Liquid.
- Analytical purity: Not specified.
- Impurities (identity and concentrations): Not specified.
- Composition of test material, percentage of components: 54.6% Hydroxotrioxorhenium.
- Isomers composition: Not specified.
- Purity test date: Not specified.
- Lot/batch No.: 10510.
- Expiration date of the lot/batch: 31 December 2013.
- Stability under test conditions: Not specified.
- Storage condition of test material: Room temperature.

Test animals

Species:

other: Not applicable.

Strain:

other: Not applicable.

Details on test animals or test system and environmental conditions:

the CORROSITEX Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives.

The test was performed on a synthetic macromolecular bio-barrier membrane resting on top of a chemical detection system (CDS). The BIOBARRIER was prepared 2 hours prior to tests. BIOBARRIER diluent and matrix powder were combined and heated to 68 deg C under smooth agitation. After complete dissolution, the solution was allowed to sit for 5 minutes. 200 ul of the BIOBARRIER were pipetted into each membrane disc, set on the tray and kept in the cold (2-8 deg C) for at least 2 hours.

Test system

Type of coverage:

other: Not applicable.

Preparation of test site:

other: Not apllicable.

Vehicle:

unchanged (no vehicle)

Controls:

other: Negative control: Citric acid (10%) in aqua dest. Positive control: Nitric acid (69%) and Phosphoric acid (85%).

Amount / concentration applied:

500 ul

Duration of treatment / exposure:

Not applicable.

Observation period:

The test system was observed until a reaction was detected or for a total of 240 minutes.

Number of animals:

Not applicable.

Details on study design:

Test system:
The CORROSITEX™ test system was purchased from Invitro International, Irvine, CA 92614.

Qualification test:
This stage was carried out to ensure the sample is compatable with the CORROSITEX™ test system. 150 ul of the test substance was added to the Qualify test tube, shaken and left to stand for one minute. A colour change or change in consistency of the CDS indicates that the test material is qualified for the assay.

Categorization test:
To establish the category cut-off times for the sample, 150 ul of the test substance was added to tubes labeled A and B. After shaking, a colour change observed in either tube was matched to the corresponding CORROSITEX™ colour charts. Test material with high acid/alkaline reserves are defined as category 1, and those with low acid/alkaline reserves as category 2. If no colour is observed, a CONFIRM reagaent is used followed by pH testing.

Classification test:
The test was performed in vials that came pre-filled with the CDS. Four replicate vials were performed on the test substance. The CDS vials were warmed to room temperature (17-25 deg C) before use. A BIOBARRIER membrane disc was placed on top of a vial filled with CDS. 500 uL of the test item was placed on top of the BIOBARRIER membrane disc and starting time recorded. This was repeated with the remaining test vials, staggering each start time. The vials were observed for a reaction. The exact time of reactions were recorded.

Testing of positive and negative control substances:
Positive (nitric acid and phosphoric acid) and negative (citric acid) control substances were tested following the same procedure as the test substance assay. The expected reaction time ranges of the positive and negative control substances are within 3 minutes, 3 - 60 minutes and >60 minutes, respectively.

Data compilation:
The CORROSITEX™ time was calculated for each replicate by subtracting the start time from the detection time. The mean CORROSITEX™ time was calculated for the four test vials. Using the corrosivity assignment time table the appropriate Packing Group Classification was assigned.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: CORROSITEX™ time

Remarks on result:

other:

Remarks:

Basis: mean time over 4 replicates. Time point: 2.21. Remarks: Corrosive. (migrated information)

Any other information on results incl. tables

Qualification/categorization test:

The test substance was compatible with the CORROSITEX™ test system based on the color change observed. In the categorization test a direct colour change was obseved in tube A and the category was read from the CORROSITEX™ colour chart. The test substance was assigned to Category 1.

 

Positive and negative control test substances:

The reaction time of positive controls nitric acid and phosphoric acid were 1.40 minutes and 16 minutes, respectively. The reaction time of the negative control was 83 minutes. 

 

CORROSITEX™ Assay:

The mean time of the test substance to activate the CDS was 2.21 minutes.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: US GHS

Conclusions:

In a well conducted in vitro membrane barrier test (CORROSITEX™ Assay), the test substance is classified as "corrosive" sub category 1A, according to US GHS, as the mean time to activate the CDS was between 0-3 minutes (category 1). The test substance is therefore assigned to Packing group 1 and to EU risk phrase R 35.

Executive summary:

In a good quality GLP study, conducted according to OECD guideline 435, the potential of the test substance to induce skin corrosion was assessed by performing the "in vitro membrane barrier test (CORROSITEX™ Assay)".

The test item was placed on top of a BIOBARRIER membrane which was on top of a vial filled with a chemical detection system (CDS). Corrosivity is determined on the ability (measured by the time taken) of a chemical to break through the barrier and subsequently activate the underlying CDS (as seen by a colour or consistency change). The mean time required for perrhenic acid solution to activate the CDS was 2.21 minutes (mean of 4 replicates).

The test substance is therefore classified as "corrosive" sub category 1A, according to US GHS, as the mean time to activate the CDS was between 0-3 minutes (category 1), and assigned to Packing group 1 and to EU risk phrase R 35.