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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The test item is classified as “non-irritant” in accordance with UN GHS “No Category”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
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
Test system:
human skin model
Source species:
human
Vehicle:
other: Dulbecco’s phosphate buffered saline
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
negative control #1
Value:
102.9
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
negative control #2
Value:
89
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
negative control #3
Value:
108.1
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
positive control #1
Value:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
positive control #2
Value:
3.1
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
positive control #3
Value:
2.9
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
test item #1
Value:
91.6
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
test item #2
Value:
99.8
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
test item #3
Value:
105.2
Interpretation of results:
GHS criteria not met
Conclusions:

In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Executive summary:

In the present study the skin irritant potential of PU-2017-775 was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a60 min exposure and 42 h post-incubation periodand compared to those of the concurrent negative controls.

The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.

The mixture of 25 mg of the test item per 300 µl aqua dest. and/or per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.

The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (98.9%) after 60 min treatment and 42 h post-incubation.

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

Additional information

Justification for classification or non-classification

In an study according to OECD Guideline for the Testing of Chemicals No. 439:In VitroSkin Irritation: Reconstructed HumanEpidermisTest Method, 28 July 2015 the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.