Registration Dossier

Administrative data

Description of key information

The test substance proved to be corrosive according to results of a Corrositex test (Gordon et al., 1998), a combination of few predictive QSAR methods (Barratt et al., 1996) and human data (Dahlin et al., 2013, IUCLID section 7.10.3)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically sound publication which provides clear results
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
Principles of method if other than guideline:
Corrositex TM is a quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
GLP compliance:
not specified
Species:
other: not applicable
Strain:
other: not applicable
Details on test animals and environmental conditions:
Not relevant, as it is an in vitro test.
Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
other: not applicable
Controls:
other: not applicable
Amount / concentration applied:
Not applicable
Duration of treatment / exposure:
Not applicable
Observation period:
Not applicable
Number of animals:
Not applicable
Irritation parameter:
other: corrosivity
Basis:
other: mean of breakthrough time
Time point:
other: 0:04:30 (4 minutes and 30 seconds)
Reversibility:
other: not applicable
Remarks on result:
other: When results of "> 3 to 60 minutes" are obtained, the substance is consequently categorized to "Packing Group II"

The study was performed at the time that the Corrositex® method went out to the market. It was the aim of the study to demonstrate the utility, reproducibility, and relevance of the Corrositex® method in prediction of the potential dermal corrosion. Therefore 85 substances with known classification and labelling were tested/ screened in this method, showing whether the method can correctly assign the substances to their correct packing group. Trifluoroacetic acid (TFA) was one of the substances tested. Results of the Corrositex® test approved the corrosive characteristics of TFA.

Interpretation of results:
other: Packing group II and Category 1A (corrosive)
Remarks:
Criteria used for interpretation of results: other: UN Dangerous Goods Transport Regulations and CLP/GHS classification and labelling
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The corrosive characteristics of the test substance were confirmed by 1.a Corrositex test (Gordon et al., 1998) that examined a number of acids among them the TFA (trifluoroacetic acid), 2.a work (Barratt et al., 1996) that validated the use of QSAR methods in predicting the corrosivity of several acids, among them TFA.

Results (IUCLID section 7.10.3) that originate from human data - case reports (Dahlin et al., 2013) gave solid confirmation for the corrosive characteristics of the test substance in humans.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008. As a result the substance is considered to be classified Skin Corr. 1A H314: “Causes severe skin burns and eye damage” under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation EC 2017/776.