Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The substance was tested through in vitro validated studies in accordance with bottom-up approach. The substance was not irritant to Reconstructed human epidermis (RHE) and Reconstructed human corneal epithelium (RhCE).

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
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
Cell source:
other: Reconstructed Human Epidermis (RHE), 3D tissue model consisting of normal, human-derived epidermal keratinocytes (NHEK).
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
About 50 mg of the test substance are weighed on a glass weighing boat. Then the sample is evenly poured on the tissue. The exact weight of the sample is not a critical factor, but it is necessary to cover all the surface of the tissue homogeneously.
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
After 24±2 hours of incubation, the tissues were transferred to new plates containing 0.9 mL of fresh medium in each well and incubated for an additional 18±2 hours (37 °C, 5% CO2).
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Vitality tests
Value:
ca. 96.7
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The average OD for negative control (C-) was f 1.257. This value corresponds to 100% vitality of the tissues.
The vitality of tissues trated with positive control was 3.5%.
The vitality of tissues trated with test item was 96.7% with SD 3.8%.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered not irritant for human skin.
Executive summary:

The test substance was tested through a validated in vitro skin irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed Human Epidermis (RHE) as % tissue viability was about 96.7. Overall, the test substance is not considered as a skin irritant.

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

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:
The test started on November 17. 2021 (9.30 a.m.), and ended on November 18, 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 492:2019
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)
Species:
human
Details on test animals or tissues and environmental conditions:
Reconstructed human corneal epithelium (RhCE) tissues
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
yes, concurrent positive control
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
percent tissue viability 
Run / experiment:
two replicates
Value:
ca. 77.2
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Mean OD for the negative control tissues (C-) was 1.319. This value corresponds to 100% vitality of the tissues.
The vitality of positive control was 20.8%.
The vitality of treated samples was 77.2% with SD% of 0.2.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on above results, the test substance may be considered as: not irritant for the eyes.
The present test does not allow to discern between irritant category 1 or 2.
Executive summary:

The test substance was tested through a validated in vitro eye irritation study in accordance with  bottom-up approach. Under the test conditions, the test substance was not irritant for Reconstructed human corneal epithelium (RhCE) as % tissue viability was about 77.2. Overall, the test substance is not considered as an eye irritant.

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

Based on the data available, the substance should not be classified for skin and eye irritation under CLP Regulation.