Zirconium tetrapropanolate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017 July to 2017 September

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium tetrapropanolate

EC Number:

245-711-9

EC Name:

Zirconium tetrapropanolate

Cas Number:

23519-77-9

Molecular formula:

C12H28O4Zr

IUPAC Name:

Zirconium tetrakis(propa-1-olato)

Constituent 2

Reference substance name:

Propan-1-ol

EC Number:

200-746-9

EC Name:

Propan-1-ol

Cas Number:

71-23-8

Molecular formula:

C3H8O

IUPAC Name:

Propan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Supplier: Borica Co., Ltd.
- Lot number: 000577Z
- Expiration date of the lot/batch: 2018-Jul-06
- CAS number: 23519-77-9

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

EpiDerm (EPI-200-MatTek Corporation) was used as reconstructed human epidermal model. It consisted of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consisted 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.

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) RECONSTRUCTED HUMAN EPIDERMIS
- Tissue batch number(s): 25837
- Date of initiation of testing: 2017-Jul-13


PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.]

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 microliter neat test material


VEHICLE
- Not used


NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter Sterile Dulbecco's phosphate buffered saline (DPBS)
- Concentration (if solution): neat

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 microliter Sodium dodecyl sulphate (SDS)
- Concentration (if solution): 5%

Duration of treatment / exposure:

60 +/- 1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, >=95% RH)

Duration of post-treatment incubation (if applicable):

42 +/- 4 h hours post-treatment incubation.

Number of replicates:

3 repliecate per run.

Test system

Vehicle:

unchanged (no vehicle)

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3

Value:

ca. 9.27

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Table 3. Mean and SD of cell viability measurements and of viability precentages after 60 min (+/- 1 min) of application and 42 h (+/-4 h) post-incubation.

Name	Code	Mean of OD	SD of OD	Mean of viability (%)	SD of viability (%)	CV (%)	Classification
DPBS	NC	1.322	0.150	100.0	11.34	11.34	Non-irritant
SDS 5%	PC	0.054	0.014	4.085	1.07	26.26	Irritant
Test item	TA2	0.123	0.022	9.266	1.67	18.08	Irritant

Predition model: test items that reduce the viability to 50% or below are irritant (I); test items with a percentage viability above 50% are considered to be non-irritant (NI).

Notes:

NC: Negative control

PC: Positive control

TA: Zirconium tetrapropanolate

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

A test item is considered to be an irritant (I) to skin in accordance with UN GHS Category 2 or EU R38 if the skin model viability after exposure and post-treatment incubation is ≤50%.
A test item may be considered as a non-irritant (NI) if the skin model viability after exposure and post-treatment incubation is > 50%.
The percentage of viability obtained with the test item Zirconium tetrapropanolate was 9.266%, therefore it was considered as irritant to the skin.

Executive summary:

The skin irritation potential of Zirconium tetrapropanolate was assessed in vitro according to OECD Test Guideline 439: In Vitro Skin irritation: Reconstructed Human Epidermis Test Method.

After 60 +/- 1 min exposure on the surface of the EpiDerm™ reconstructed human epidermis and a 42 +/- 4 h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 9.266% and therefore:

Zirconium tetrapropanolate

was classified as Irritant to the skin.