[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March to April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

This study addresses the human health endpoint skin irritation. It makes use of reconstructed
human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes)
which closely mimics the histological, morphological, biochemical and physiological properties
of the upper parts of the human skin, i.e., the epidermis. The use of reconstructed human
epidermis (RhE) is also recommended by the OECD and other regulatory authorities. SkinEthic
RHE model has been validated and is part of OECD validated reference methods (VRMs) and is
also a recommended model for conducting in vitro skin irritation studies. The results of the study
are believed to be of value in predicting the potential of inducing skin irritation by the test item in
humans.

Details on test system:

The test system used for the in vitro skin irritation test was reconstructed human epidermis RHE model
consists of normal human keratinocytes cultured for 17-days on an insert of 0.5 cm
polycarbonate filter at the air-liquid interface in a chemically defined growth medium. The cells
form a multilayered, highly differentiated and stratified epidermis model of the human epidermis
that consists of main basal, supra basal, spinous and granular layers and a functional stratum
corneum.
RHE model, were procured from SkinEthic Laboratories, Episkin 4, Rue Alexander Fleming, 69366 Lyon
Cedex 07, France; were used in the study (Lot N°19-RHE-027, APPENDIX 5).

Control samples:

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

16 µL/0.5 cm2

Duration of treatment / exposure:

42 min.

Duration of post-treatment incubation (if applicable):

42 min.

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 1.9

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the results of this study, the classification for POLIOL MB 600 is as mentioned below:

Globally Harmonized System of Classification and Labelling of Chemicals: Category 2 (Skin Irritant)

Executive summary:

This study was performed to evaluate the non-irritant and irritant potential of

POLIOL MB 600 using reconstructed human epidermis (RHE) tissue in accordance with the United Nations 

Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).  

Tissues were exposed to the negative control (Dulbecco’s Phosphate Buffered Saline (DPBS), positive 

control (sodium dodecyl sulfate, 5% aqueous (SDS)) and POLIOL MB 600  in triplicate for 42 minutes at 

room temperature.  

The mean cell viability in tissues treated with the test item was 1.9% after 42 minutes exposure. A 

significant reduction in percent cell viability was observed in treated tissues when compared with that of the 

concurrent negative control.  

 

The Optical density (OD) values for the negative control replicates were between 1.633 and 1.853, against 

the guideline requirement of ≥ 0.8 and ≤ 3.0 (≥ 1.2 as per SkinEthic SOP). The OD of the blank was 

between 0.040 and 0.044 which met the guideline requirement of OD < 0.1. The positive control showed 

a 1% cell viability, against the acceptance criteria of <40% for the SkinEthic RHE model, when compared 

with that of the concurrent negative control. Variation between tissue replicates (i.e., CV% value) was 

17.00% for positive control and 6.46% for negative control against the guideline requirement of ≤ 18%, 

which demonstrate the efficiency of the test system, SkinEthic 

replicates (i.e., CV% value) was 20.21% for the test item group. All criteria for a valid study were met as 

describe in the study plan.  

Based on results of this study, the classification for POLIOL MB 600 is as follows:  

Globally Harmonized System of Classification and Labelling of Chemicals   :  

Category 2 (Skin Irritant) 

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read across from structural analogue, justification can be found attached in section 13.2.

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 1.9

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on the results of the Read across study, the classification for MBC 450 is as mentioned below:

Globally Harmonized System of Classification and Labelling of Chemicals: Category 2 (Skin Irritant)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March to April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Species:

other: bovine

Amount / concentration applied:

750 μL (undiluted) POLIOL MB 600 in normal saline

Duration of treatment / exposure:

10 min.

Duration of post- treatment incubation (in vitro):

10 min.

Irritation parameter:

in vitro irritation score

Value:

ca. 74.56

Positive controls validity:

valid

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read across from structural analogue, justification can be found attached in section 13.2.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

in vitro irritation score

Value:

ca. 74.56

Positive controls validity:

valid

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Justification for classification or non-classification

According to the studies, we decided to classify the substance as Skin irritation 2 and Eye damage 1.