Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 28, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted using the In Vitro International Corrositex Assay which is a standardized and quantitative in vitro corrosivity test. EU/OECD approval this type of test on July 19, 2006.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The method to determine United nations' Packing Group
Deviations:
no
Remarks:
according to the study the testing protocol was followed.
Principles of method if other than guideline:
Corrositex uses a synthetic membrane-based or matrix dics system to determine the United Nation packing group classification of chemicals. The results are expressed as a break-through time and correlate with rabbit dermal corrosivity tests. A glass vial filled with a chemical detection fluid is capped by a" proprietary bio-barrier membrane" which is designed to mimic the effect of corrosives on living skin.

Corrositex measures the time required for a test article to pass through a hydrated collagen matrix and supporting filter membrane. As the corrosive sample passes through or destroys this bio-barrier, the underlying liquid Chemical Detection System changes color or texture. The time it takes for the sample to break through the membrane is recorded and compared to a classification chart to determine corrosivity/noncorrosivity for assignment of the proper U.N. Packing Group classification for U.S. DOT or EPA compliance.
GLP compliance:
not specified
Remarks:
GLP statement was not included in this study report, but the procedures for the tests were closely followed.

Test material

Constituent 1
Reference substance name:
Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction
EC Number:
276-431-5
EC Name:
Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction
Cas Number:
72162-23-3
Molecular formula:
UVCB substance. Formula not available
IUPAC Name:
Not available for a UVCB
Details on test material:
See section 1

Test animals

Species:
other: In Vitro test
Strain:
other: In Vitro test
Details on test animals or test system and environmental conditions:
No test animals were used in this study. Bio-barrier membrane or matrix discs were prepared and stored at 2.8 degrees celsius for at least 2 hours prior to conducting the assay.

Test system

Type of coverage:
other: the vials are open at the top and observed.
Preparation of test site:
other: 4 vials are used in this test.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Approximately 0.5 grams of the Corfree® M1
Duration of treatment / exposure:
>4 hours
Observation period:
Vials l-4 were observed for > 240 minutes. 
Number of animals:
No animals were used in this In Vitro study.
Details on study design:
The In Vitro International Corrositex Assay which is a standardized and quantitative in vitro corrosivity test is conducted in 3 steps. Step 1 is the qualifying step. Corfree® M1 (100 mg) is added to the Corrositex test tube to determine if it is compatible with the test system. The tube is shaken and allowed to stand for 1 minute. The tube is observed for a color change or change of consistency at the sample fluid interface. If the amber fluid changes color or consistency, we proceed to Step 2. If a physical change is not observed the substance is not suitable for the Corrositex system. Step 2 is where the categorize of cut-off times for the sample is established. Corfree® M1 (100 mg/vial) is added to two Corrositex test tube which are capped and shaken until mixed. If a color change is noted in either tube the color is matched to a corresponding color chart on the Corrositex Testing Protocol Poster. The appropriate category is assigned according to the color found on the poster. If no color is observed in either tube 2 drops of a confirm reagent is added to Tube B, the tube is shaken until mixed. The resulting color is matched to a corresponding color chart on the Corrositex Testing Protocol Poster. The appropriate category is assigned according to the color found on the poster. Step 3 is the classification step used to determine the appropriate Packing Group. Several vials (4) are used for sample replicate testing. There is a positive and negative control. Corfree® M1 (500 mg) is added to top of the bio-barrier disc; the timer is started the instant the test substance is applied. The vials are observed for changes in the membranes' structure by colormetrics. The category assigned and the mean value of the breakthrough time for all 4 samples replicate vials determine the packing group.

Results and discussion

In vivo

Irritant / corrosive response data:
No breakthrough occured in Vials 1-4. Under the conditions of this test, Corfree® M1 was not a corrosive substance and was assigned to non-corrosive.
Other effects:
No other effects were observed.

Any other information on results incl. tables

No other information is available on this test.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Corfree® M1 was not a corrosive substance and was assigned to non-corrosive.
Executive summary:

Dermal Irritation (DuPont, 1999): In a non-GLP, non-guideline study, a membrane disk containing the bio-barrier matrix was placed into a chemical detection system (CDS) vial. Approximately 0.5 grams of the Corfree® M1 (consisting of 46 wt% Dodecanedioic acid, 31 wt% Undecanedioic acid, 5 wt % Sebacic acid and 11 wt% other dibasic acids), ground with a mortar and pestle, was placed on the top of the disc. The vial was then observed for a change in the CDS. This procedure was followed for each of 4 test vials. Vial 5 was similarly treated with a positive control (sulfuric acid) and Vial 6 was similarly treated with a negative control (citric acid). Vials l-4 were observed for > 240 minutes. 

The test substance did not pass through any of the membranes. It was concluded that Corfree® M1 was not a corrosive substance.