Registration Dossier

Administrative data

Description of key information

No in vivo data are available for skin or eye irritation; however the pH of the substance indicates that corrosivity is likely and the corrosive properties of the substance have been confirmed experimentally in an in vitro skin corrosion study conducted using the Corrositex Packing Group Assay. 

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:
supporting study
Study period:
June 22, 1993 - February 23, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The Corrositex assay is a standardized and quantitative in vitro corrosivity test. It is based on the time that is required for the test sample to pass through a biobarrier membrane and produce a change in the chemical detection system. The Corroxitex Biobarrier Membrane consists of a reconstituted matrix.
GLP compliance:
not specified
Test system:
other: Corrositex
Species:
other: Biobarrier
Strain:
other: Biobarrier
Details on test animals and environmental conditions:
Not applicable
Type of coverage:
other: direct addition to the membrane disc
Preparation of test site:
other: Not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: Not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500ul
Duration of treatment / exposure:
At least 4 hours
Observation period:
At least 4 hours
Number of animals:
Not applicable
Details on study design:
The purpose of the study was to evaluate the potential corrosivity of the test article as measured by its penetration through a calibrated biobarrier into a chemical detection system. The test article was tested in at least one definitive assay (six replicates) to determine the packing group and the mean break through time.
Prior to the main test, the ability of the test article to produce a change in the chemical detection system when added directly was determined.
The experimental design of this study consisted of a pH determination, and a definitive Corrrositex assay in the chemical detection system. The Corrositex assay was evaluated on the basis of the colour change of the chemical detection system. The time that a colour change was observed was recorded manually and the average of the six replicates was used to determine the packing group.
Sodium hydroxide (NaOH) was used as a positive control and colour was used as a blank (negative control).
Irritation / corrosion parameter:
other: breakthrough time
Remarks:
Corrositex
Run / experiment:
Breakthrough time in [min]
Value:
ca. 20
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
The break through time for DBU ranged from 18 – 22 minutes with an average of 20 minutes based on six replicates.

No further data

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: The Corrositex assay
Conclusions:
The break through time for DBU ranged from 18 – 22 minutes with an average of 20 minutes based on six replicates.
The pH of DBU was reported as 14.0 and it was designated in packing group II.
Executive summary:

The corrosivity potential of DBU was evaluated using the Corrositex assay. The Corrositex assay is a standardized and quantitative in vitro corrosivity test. It is based on the time that is required for the test sample to pass through a biobarrier membrane and produce a colour change in the chemical detection system. The Corroxitex Biobarrier Membrane consists of a reconstituted matrix.

Evaluation of the potential corrosivity of the test article was measure by its penetration through a calibrated biobarrier into a chemical detection system. The test article was tested in at least one definitive assay (six replicates) to determine the packing group and the mean break through time.

Prior to the main test, the ability of the test article to produce a change in the chemical detection system when added directly was determined.

The experimental design of this study consisted of a pH determination, and a definitive Corrrositex assay in the chemical detection system. The Corrositex assay was evaluated on the basis of the colour change of the chemical detection system. The time that a colour change was observed was recorded manually and the average of the six replicates was used to determine the packing group.

Sodium hydroxide (NaOH) was used as a positive control and colour was used as a blank (negative control).

The test article was administered by direct addition to the membrane disc which was placed onto a vial containing the chemical detection system. The vial was observed continuously for ten minutes and then at one and four hours after addition of the test material to record any changes in the chemical detection system. The first indication of the presence of the test article was detected as a colour change in the chemical detection system as compared to the blank control. The time of this change was recorded. The packing group was determined by the time interval the sample took to break through the biobarrier matrix.

The break through time for DBU ranged from 18 – 22 minutes with an average of 20 minutes based on six replicates. The pH of DBU was reported as 14.0 and it was designated in packing group II.

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

No in vivo studies are available on the eye or skin irritation effects of the substance. In an in vitro skin corrosion study conducted using the Corrositex Assay, the substance has been shown to be corrosive (Packaging Group II) and a strong base (pH 14) in a Corrositex Packing Group Assay. On the basis that the substance is a strong base and has been shown to be corrosive in experimental systems, it can therefore be predicted to be corrosive to skin and a severe eye irritant.

Justification for classification or non-classification

No in vivo studies of skin and eye irritation are available. Based on the pH of the substance, evidence of corrosive effects from a Corrositex Packing Group Assay and the designation of the substance in Packaging Group II, classification for corrosivity is considered appropriate. The substance is therefore classified as Skin Corrosive (Category 1B) H314: causes severe skin burns and eye damage according to CLP Regulation EC No. 1272/2008.