Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to the annex VII of REACH regulation, under the study under the point 8.3.1 (skin sensitisation in vitro / in chemico) does not need to be conducted if the substance is classified as skin corrosion (Category 1). An OECD 435 was performed on the substance and the conclusion is that Barium peroxide has to be classified in category 1B. Consequently, a study on skin sensitisation is scientifically not necessary.
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 01 MArch to 20 April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Bernardy, Barium peroxide, code BAO20
- batch No.: 1704349
- Purity test date: 26/12/2017
- date of reception: 23/01/18
- Expiry date: 26/12/2019

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test system:
artificial membrane barrier model
Justification for test system used:
Testsystem recommended in the OECD 435 Guideline.
Vehicle:
unchanged (no vehicle)
Details on test system:
SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: Yes (In Vitro International supplied by INT.E.G.RA. Srl, batch No. CT100217)
- Components: The test system is composed of two components, a synthetic macromolecular bio-barrier (MEMBRANE DISCS, batch No. CT100217) and a Chemical Detection System (CDS).
- Delivery date: 15/12/2017
- Date of initiation of testing: 01/03/2018
- Apparatus and preparation procedures: Detailed in §4.2.5 of the final report.

WAS THE COMPATIBILITY TEST PERFORMED: Yes

WAS THE TIMESCALE CATEGORY TEST PERFORMED: Yes

TEMPERATURE USED:
- Temperature used during treatment: room temperature
- Temperature during storage: 6°C ± 3°C

METHOD OF DETECTION
- Chemical detection system (CDS) used

METHOD OF APPLICATION:
- 500 mg of test item BARIUM PEROXIDE in quadruplicate,
- 110 ± 15 mg of positive control sodium hydroxide in single,
- and 500 μL of negative control 6% propionic acid solution in single.

NUMBER OF REPLICATES: 4 replicates + 1 positive control + 1 negative control

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive 1B to skin if the time elapsed between application of the test substance to the membrane barrier and barrier penetration is > 3 to 60 min.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
- 500 mg of test item BARIUM PEROXIDE in quadruplicate,
- 110 ± 15 mg of positive control sodium hydroxide in single,
- and 500 μL of negative control 6% propionic acid solution in single.
Duration of treatment / exposure:
planned to be 240 min
Number of replicates:
4
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
240 min
Value:
30.83
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
yes

 

Corrositex time (hr:min:sec)

Corrositex Category : 1

Test item

Positive control

Negative control

Replicate 1

0:43:32

0:19:31

>1:00:00

Replicate 2

0:39:20

Replicate 3

0:16:37

Replicate 4

0:23:51

Mean

0:30:50

Standard deviation

0:12:42

CLASSIFICATION in accordance with GHS subcategories

According to the calculated means, the test item has to be classified in Category 1B

UN Packing Group required

UN Packing Group II

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item BARIUM PEROXIDE has to be classified in Category 1B “Corrosive” and the UN Packaging group II is required.
The hazard statements “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are required.
Executive summary:

The aim of the study was to evaluate the possible effects of the test item BARIUM PEROXIDE after deposition on a synthetic proteinaceous bio-barrier and monitoring using a Chemical Detection System (CDS).

The test item BARIUM PEROXIDE was applied as supplied, at the dose of 500 mg, onto 4 synthetic proteinaceous bio-barriers. Timescale Category Test showed that the test item belongs to Corrositex Category 1.

The experimental protocol was established in accordance withO.E.C.D. Test Guideline No. 435 adopted 28 July 2015.

 

The test item disrupted the membrane after 30 minutes and 50 seconds.

 

As expected, the negative control (propionic acid 6% (v/v)) did not disrupt the membrane and was not corrosive.

As expected, the positive control (sodium hydroxide) was found to be corrosive (GHS subcategory 1B) and disrupt the membrane after 19 minutes and 31 seconds.

 

In accordance with the Regulation EC No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test itemBARIUM PEROXIDE has to be classified in Category 1B “Corrosive” and the UN Packaging group IIis required.

The hazard statements “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion