Registration Dossier

Administrative data

skin corrosion: in vitro / ex vivo
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 a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
Justification for type of information:
A 50g/L solution of the substance has a pH of 1.2, therefore it can be considered to be corrosive for the purpose of CLP classification
Reason / purpose for cross-reference:
data waiving: supporting information
water solubility
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
In-house data assessment.
equivalent or similar to guideline
OECD Guideline 105 (Water Solubility)
Principles of method if other than guideline:
Solubility at range of pH was investigated as has relevance for environmental and toxicological assessments.
GLP compliance:
Type of method:
other: Observations
Specific details on test material used for the study:
Batch number of test material: C-04-3584
Key result
Water solubility:
ca. 1 000 g/L
Conc. based on:
test mat.
20 °C
ca. 1.2
Remarks on result:
completely miscible
pH unadjusted
Water solubility:
> 50 g/L
Conc. based on:
test mat. (total fraction)
20 °C
ca. 1.5
Remarks on result:
other: pH buffered for evaluation of solubility at different pH
The solubility is pH dependant with reduced solublity at pH 5 or more, suggesting formation of hydroxide / oxide
The substance supplied is typically in acidic solution

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion