1-Heptanol, 2-propyl-, 1,1'-carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-08-16 to 2011-09-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study OECD and EU guidelines were followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

July 22, 2010

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology BASF SE

Test material

Test material information

Constituent 1

Reference substance name:

bis(2-propylheptyl) carbonate

EC Number:

627-085-2

Cas Number:

1238449-42-7

Molecular formula:

C21H42O3

IUPAC Name:

bis(2-propylheptyl) carbonate

Constituent 2

Reference substance name:

Carbonic acid, bis (2-propylheptyl)ester

IUPAC Name:

Carbonic acid, bis (2-propylheptyl)ester

Test material form:

other: liquid

Test animals

Species:

human

Strain:

other: human epidermis model

Details on test animals or test system and environmental conditions:

Test system:
- Model: three dimensionl human epidermis model:
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: negative control (historical control data)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL of the test substance

Duration of treatment / exposure:

1 hour

Observation period:

42 hours

Number of animals:

NA

Details on study design:

TEST SITE
- Area of exposure: 0.6 cm2

SCORING SYSTEM:
Table(s) and/or figure(s) of measured parameters presented in the report were produced using PC based tabular calculation software. The mean and individual data were not always rounded but the significant digits were produced by changing the display format. As a consequence, calculation of mean values using the individual data presented in the report will, in some instances, yield minor variations in value.
- Principle: The OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) is used for evaluating whether or not a test material is irritant.
- Calculation of individual and mean optical densities: The individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of three tissues treated in the same way is calculated.
- Tissue viability: The quantification of tissue viability is presented as the quotient of the mean OD570 divided by the respective OD570 NC value in percent.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: mean OD570

Basis:

other: tissue 1

Time point:

other: 42 h

Score:

1.974

Results 2

Irritation parameter:

other: mean OD570

Basis:

other: tissue 2

Time point:

other: 42 h

Score:

1.989

Results 3

Irritation parameter:

other: mean OD 570

Basis:

other: tissue 3

Time point:

other: 42 h

Score:

2.012

Results 4

Irritation parameter:

other: mean OD570

Basis:

mean

Time point:

other: 42 h

Score:

1.992

Results 5

Irritation parameter:

other: viability (% of negative control)

Basis:

other: tissue 1

Time point:

other: 42 h

Score:

99.6

Results 6

Irritation parameter:

other: viability (% of negative control)

Basis:

other: tissue 2

Time point:

other: 42 h

Score:

100.4

Results 7

Irritation parameter:

other: viability (% of negative control)

Basis:

other: tissue 3

Time point:

other: 42 h

Score:

101.5

Results 8

Irritation parameter:

other: viability (% of negative control)

Basis:

mean

Time point:

other: 42 h

Score:

101

Irritant / corrosive response data:

The test substance is not able to reduce tetrazolium salt (MTT) directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was about 101%.