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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

In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guideline 431 and in compliance with GLP, mean cell viability was 94.517% after 3 minutes of exposure adn 102.625% after 1 hour of exposure. Therefore, the test item should not be classified as corrosive.


In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guildeline 439 and in compliance with GLP, the mean relative tissue viability for the substance was below 50%, the substance is therefore considered to be irritant.


The test item had an MQS score of 47.4 and according to OECD guideline 496 is predicted to be classified as UN GHS Category 1.

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:
14 December 2021 - 05 May 2022
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult donors
Vehicle:
unchanged (no vehicle)
Details on test system:
The reconstructed human epidermal model EpiDerm™ (EPl-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised 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.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
30µL
Duration of treatment / exposure:
1 hour
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3 of each, negative control, positive control, and test item
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
9.549
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
other: Irritant to the skin
Conclusions:
The relative mean tissue viability obtained after a 1 hour treatment with the substance compared to the negative control tissues was 9.549%. Since the mean relative tissue viability for the substance was below 50%, the substance is considered to be irritant.
Executive summary:

In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guildeline 439 and in compliance with GLP, the mean relative tissue viability for the substance was below 50%, the substance is therefore considered to be irritant.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October 2022 - 22 November 2022
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult donors
Vehicle:
unchanged (no vehicle)
Details on test system:
The reconstructed human epidermal model Epiderm™ (EPl-200 MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differential model of the human epidermis. It consists of organised 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.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
3 minutes and 1 hour
Number of replicates:
3 of each, negative control, positive control and test item
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
102.625
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes
Value:
94.517
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
other: non-corrosive according to Regulation (EC) No 1272/2008
Conclusions:
The test item was evaluated for skin corrosion using the EpiDerm tissue model following OECD TG 431 and was found to be non-corrosive.
Executive summary:

In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guideline 431 and in compliance with GLP, mean cell viability was 94.517% after 3 minutes of exposure adn 102.625% after 1 hour of exposure. Therefore, the test item should not be classified as corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
14 October 2022 - 20 December 2022
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
human
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
200 µL per well of 1) 5% and 0.05% test item 2) 0.01% positive control 3) saline (vehicle/solvent)
Duration of treatment / exposure:
5 minutes
Duration of post- treatment incubation (in vitro):
2 hours of incubation with MTT, 1 hour of shaking.
Number of animals or in vitro replicates:
3
Details on study design:
Three definitive assays were performed for the test article at two concentrations of 5% and 0.05%. The positive control (0.01 % Sodium Lauryl Sulfate (SLS) prepared in saline), the procedural control (Growth Medium), and the solvent control (saline), were tested concurrently. Each treatment group was exposed in triplicate wells containing a confluent monolayer of SIRC cells. After the 5-minute exposures, the treatments were removed, the wells were rinsed, and then a 0.5 mg/mL MTT solution was added to the test wells to assess relative viability. The relative viabilities of the positive control and test article were determined using the saline solvent control.
Irritation parameter:
percent tissue viability 
Run / experiment:
0.05%, 5 minutes
Value:
1.5
Vehicle controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent tissue viability 
Run / experiment:
5%, 5 minutes
Value:
104
Vehicle controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
other: Did not fall into category 1 or no category. No standalone prediction can be made.
Conclusions:
No standalone prediction can be made, since cell viability was ≤ 70% at a 5% concentration and > 70% at 0.05% concentration.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Justification for classification or non-classification

Based on the positive result in the skin irritation test and the negative result with the skin corrosion test, the test substance needs to be classified as a skin irritant (bottom up approach). Based on the positive result in the eye irritation/corrosion test, the substance needs to be classified as causing serious eye damage. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and GHS this results in skin irritation category 2, H315: Causes skin irritation and serious eye damage category 1, H318: Causes serious eye damage.