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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

An in vitro skin corrosion study according to OECD 435 was performed with the substance in 2022. This study is regarded as key study and used for classification with regard to irritation/corrosion to eye and skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th April 2022
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes
Test system:
artificial membrane barrier model
Justification for test system used:
The Corrositex® test is an internationally accepted (1)(2)(3) validated test method for skin corrosion according to Globally Harmonized System (GHS) classifications
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
500 µl to each replicate
Duration of treatment / exposure:
Each replicate was observed until the membrane was destroyed
Number of replicates:
4
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
50 - 58
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
2
Value:
50 - 58
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
3
Value:
50 - 58
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
4
Value:
50 - 58
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The findings of the performed study lead to the designation of this sample as a UN Packing Group III/GHS 1C.
Executive summary:

A single sample was analyzed by the Corrositex method to determine its corrosive potential and GHS and U.N. Packing Group designations.
The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were difficult to identify at a precise moment. It took a while to develop a visible color formation. A breakthrough time between 50 and 58 minutes from four replicates was observed to destroy the synthetic biobarriers.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Additional information

Justification for classification or non-classification

Recent testing of the substance in an OECD 435 study on skin corrosion using the Corrositex test system showed the potential of the substance for skin corrosion. The findings of the study lead to the classification Skin Corrosion, Cat 1C. Based on this classification the substance is also classified as serious eye damage, Cat. 1.