Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12-13 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
yes
Remarks:
the epidermis units were incubated with MTT for 2 hours 1 minute instead of 3 hours (± 15 min)
GLP compliance:
yes (incl. certificate)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult humanderived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
Details on test system:
Kit Contents
Units: EPISKINTM(SM) plate containing up to 12 reconstructed epidermis units (area: 0.38 cm2) each reconstructed epidermis is attached to the base of a tissue culture vessel with an O-ring set and maintained on nutritive agar for transport.
Plate: 12-well assay plate
Punch: EPISKINTM(SM) biopsy punch for easy sampling of epidermis
Medium: A flask of sterile “Maintenance Medium” (Batch No.: 17 MAIN3 043; Exp. Date: 18 October 2017)
A flask of sterile “Assay Medium” (Batch No.: 17 ESSC 040; Exp. Date: 18 October 2017)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 μL
Duration of treatment / exposure:
4 hours
Duration of post-treatment incubation (if applicable):
4 hours
Number of replicates:
2 replicates each for test item, negative control and positive control
Irritation / corrosion parameter:
% tissue viability
Value:
88
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is non-corrosive to the skin
Executive summary:

The skin corrosivity has been assessed using the EPISKIN model test according to the OECD 431. The tissue viability was 88% and the substance is therefore non-corrosive.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4-6 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult humanderived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
Source strain:
other: Human
Vehicle:
other: Deionised water
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Disks of EPISKINTM (SM) (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated
at 37°C for 42 hours in an incubator with 5% CO2, in a >95% humidified atmosphere. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2, in a >95% humidified atmosphere,
protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.

PBS and 5% (w/v) Sodium Dodecyl Sulphate (SDS) solution treated epidermis were used as negative and positive controls, respectively (three units / control). For each treated tissue, the viability was expressed as a % relative to the negative control. If the
mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test item is considered to be irritant to skin.
Irritation / corrosion parameter:
% tissue viability
Value:
90.3
Negative controls validity:
valid
Positive controls validity:
not valid
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is non-irritant to skin.
Executive summary:

The skin irritation was assessed using the EPISKIN test system according to OECD 439 test guideline in compliance with CLP. The substance is not irritating to skin.

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
chicken
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30μL of test item with no vehicle.
Duration of treatment / exposure:
10 seconds, after which the eyes were rinsed with physiological saline
Duration of post- treatment incubation (in vitro):
4 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
in vitro irritation score
Value:
0
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance has caused no irritation.
Executive summary:

The neat test item has been exposed to isolated chicken eyes for 10 seconds, after which the eyes were rinsed with physiological saline. Concurrent positive and negative controls were undertaken. The test vitem cause no severe or mild irritation, while controls responded as expected.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The skin corrosivity has been assessed using the EPISKIN model test according to the OECD 431. The tissue viability was 88% and the substance is therefore non-corrosive.

The skin irritation was assessed using the EPISKIN test system according to OECD 439 test guideline in compliance with CLP. The substance is not irritating to skin.

The neat test item has been exposed to isolated chicken eyes for 10 seconds, after which the eyes were rinsed with physiological saline. Concurrent positive and negative controls were undertaken. The test vitem cause no severe or mild irritation, while controls responded as expected.