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Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 2012-07-23 to 2012-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
In accordance with GLP.

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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2012-09-07

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium di-tert-butyl phosphate
EC Number:
619-702-9
Cas Number:
33494-80-3
Molecular formula:
C8H18KO4P
IUPAC Name:
Potassium di-tert-butyl phosphate
Test material form:
solid: crystalline

In vitro test system

Test system:
human skin model
Source species:
human
Details on test system:
SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: Yes
Lot number CT052112
Expiry date May 2014

WAS THE COMPATIBILITY TEST PERFORMED: Yes

WAS THE TIMESCALE CATEGORY TEST PERFORMED: Yes

METHOD OF DETECTION
- Chemical or electrochemical detection system: Chemical detection system

METHOD OF APPLICATION: A membrane disc was placed on top of the vials. An aliquot of test item occupying 0.5 ml was evenly applied onto the top of the membrane disc.

NUMBER OF REPLICATES: 4

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean breakthrough time is less than 60 min as the substances was categorized in Category 2.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

VEHICLE
No vehicle

NEGATIVE CONTROL
- Concentration (if solution): 10% w/v
Duration of treatment / exposure:
60 min
Number of replicates:
4

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1 to 4
Value:
> 60
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Qualification Screen

The test item produced an immediate colour change therefore qualified for use in the CORROSITEX assay.

Categorisation Screen

The test item was assigned into Category 2.

Assay

 

Test item Breakthrough Time

Vial 1

Vial 2

Vial 3

Vial 4

Start time

(hr:min:sec)

00:00:00

00:04:00

00:05:00

00:06:00

Detection time

(hr:min:sec)

Not applicable

Not applicable

Not applicable

Not applicable

Breakthrough time

(hr:min:sec)

Not applicable

Not applicable

Not applicable

Not applicable

 

No breakthrough observed after 60 minutes

  

 

The results of the assay were accepted on condition of adherence to the positive and negative control item ranges given in the following table:

 

Chemical

Concentration

(weight %)

Breakthrough Time

(hr:min:sec)

Positive Control

Sulphuric Acid

95 – 98

00 :01 :00

Negative Control

Citric Acid

10

>60 minutes

hr = hour(s)

min = minute(s)

sec = second(s)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to be non-corrosive.
Executive summary:

This in vitro study was performed to assess the skin corrosion potential of DTBPOK, in a corrositex assay according to the OECD 435 Guideline and GLP.

The qualification screen qualified the test item for the corrositex assay. The test item was assigned to category 2.

The results for the positive and negative control were acceptable.

In all four replicates, the breakthough time was > 60 minuges. Therefore, DTBPOK is considered to be non-corrosive.

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