Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Skin irritation / corrosion: 
An in vitro skin corrosion study is available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles. Based on the results, the substance is not corrosive. 
In accordance with column 2 of REACH Annex VIII, an in vivo skin irritation study does not need to be conducted since the acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).
Eye irritation:
Based on the document "Guidance on the Application of the CLP Criteria" (ECHA 2011), section 3.3.2.1.2.3, since the pH is > 8.6 and the analogue substance is classified according to harmonised classification as Severe eye damage Category 1, the registered substance is also proposed to be classified as Severe eye damage Category 1.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

An in vitro skin corrosion study is available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles. Based on the results, the substance is not corrosive.

In accordance with column 2 of REACH Annex VIII, an in vivo skin irritation study does not need to be conducted since the acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).

Eye irritation:

Based on the document "Guidance on the Application of the CLP Criteria" (ECHA 2011), section 3.3.2.1.2.3, since the pH is > 8.6 and the analogue substance is classified according to harmonised classification as Severe eye damage Category 1, the registered substance is also proposed to be classified as Severe eye damage Category 1.


Justification for selection of skin irritation / corrosion endpoint:
An in vitro skin corrosion study is available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.
In accordance with column 2 of REACH Annex VIII, an in vivo skin irritation study does not need to be conducted since the acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg body weight).

Justification for selection of eye irritation endpoint:
Based on the document "Guidance on the Application of the CLP Criteria" (ECHA 2011), section 3.3.2.1.2.3, since the pH is > 8.6 and the analogue substance is classified according to harmonised classification as Severe eye damage Category 1, the registered substance is also proposed to be classified as Severe eye damage Category 1.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, the substance is classified as Severe eye damage Category 1.