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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
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 material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,8-Diazabicyclo(5,4,0)undecen-7
- Analytical purity: 99.6 %

In vitro test system

Test system:
other: Corrositex

Test animals

Species:
other: Biobarrier
Strain:
other: Biobarrier
Details on test animals and environmental conditions:
Not applicable

Test system

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).

Results and discussion

In vitro

Results
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.

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

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.