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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No data.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.5 the study of acute oral toxicity does not need to be conducted since the substance is a strong acid (pH ≤ 2.0 in water) and/or the substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.13.2, July 2017) the study does not need to be conducted.
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
No study available due to the substance being classified as corrosive to the skin.
Applicant assessment on comparable substances does not indicate the substance potentially showing significant toxicity equivalent to Regulation (EC) 1272/2008: Acute Oral Toxicity - category 4 levels. A discriminating dose of LD50 oral > 2000 mg/kg bw would be expected by expert judgement in the absence of significant local toxicity (skin corrosion) following single exposure to the substance.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) 1272/2008 for acute toxicity: oral.