Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

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)
Version / remarks:
July 19, 2006
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Na-tert.-Butylat L (PRD 30153329)
- Analytical purity: 98.1g/100g (homogenous)
- Lot/batch No.: 35694816K0
- Stability under test conditions: stability under storage conditions was guaranteed by the sponsor
- pH-value: ca. 14 (undiluted test substance, moistened with water)

Test animals

Species:
other: in vitro
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
MATERIAL AND TECHNICAL EQUIPMENT:
- Corrositex Kit containing reagents required for qualification and categorization screen, biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System (InVitro International, Irvine, California)

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: Negative control: 10% Citric Acid, Positive Control: Sodium Hydroxide (solid)
Amount / concentration applied:
Qualification Screen:
100 mg

Categorization Screen:
100 mg to tube A and B each

Corrositex Assay:
350 mg
Duration of treatment / exposure:
Following application of test substance onto the mebranes, time until break through of the substance is monitored (indicated by change in the Chemical Detection System).
Observation period:
up to 240 minutes, for substances determined into category 1 by Categorization screen
up to 60 minutes, for substances determined into category 2 by Categorization screen
Number of animals:
not applicable
Details on study design:
TEST SUBSTANCE:
- 4 vials were used for the experiment
- first vials was observed for 3 minutes, if no color change was observed the remaining 3 were treated with test substance and time until break through of the substance was monitored and recorded

POSITIVE CONTROL
- one pellet of Sodium Hydroxide was applied on top of membrane and vial was monitored until break through occured

NEGATIVE CONTROL
- 500 uL of 10% citric acid were applied on top of membrane, vial was observed for 60 minutes, if no break through occured, evaluated as being non-corrosive

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: break through time
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 8 min 16 seconds. (migrated information)

In vivo

Irritant / corrosive response data:
Na-tert.-Butylat L showed a mean break through time of 8 minutes and 16 seconds.
Other effects:
not applicable

Any other information on results incl. tables

Table2: Findings

 

 Break Through Time [min:s]            

   vial 1  vial2  vial 3  vial 4  Mean
 11/0395 -1  6:50  8:08  9:13  8:53  8:16
 Controls:              
 PC: Sodium Hydroxide, solid  11:50  -  -  -  -
 NC: 10% citric acid  NB  -  -  -  -

Table3: Historical Control Data

   mean [min:s]  SD [min:s]
 Positive Control (NaOH, solid)  12:34  02:43
 Negative Control (10% citric acid)  NB  -

NB = No Breakthrough

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive)
Remarks:
Migrated information