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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.