Sodium butanolate

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17. Jun.- 17. Aug. 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test material information

Constituent 1

Reference substance name:

Sodium butanolate

EC Number:

219-144-2

EC Name:

Sodium butanolate

Cas Number:

2372-45-4

Molecular formula:

C4H10O.Na

IUPAC Name:

sodium butan-1-olate

Details on test material:

- Name of test material (as cited in study report): Na-n-Butylat Lsg. 20 % (PRD 30285885)
- Physical state: homogenous liquid
- Analytical purity: not given (see test report No.: 11S02637)
- Lot/batch No.: 000STD77L0
- Stability under test conditions: stability under test conditions was guaranteed by the sponsor

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:

open

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:
150 µL

Categorization Screen:
150 µL to tube A and B each

Corrositex Assay:
500 µL

Duration of treatment / exposure:

Following application of test substance onto the mebranes time until break through of the susbstance 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
upt 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
- 500µL 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: 15 min 52 sec. (migrated information)

In vivo

Irritant / corrosive response data:

The mean break through time determined for Na-n-Butylat Lsg. 20% was 15 minutes and 52 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	16:17	16:00	15:40	15:30	15:52
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)	12:38	02:45
Negative Control (10% citric acid)	NB	-

NB = no break through within maximum observation period (60 min.)

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU