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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:
key study
Study period:
From April 27 to May 3, 2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Chloro-2-methylpropanoyl chloride
EC Number:
687-783-8
Cas Number:
13222-26-9
Molecular formula:
C4H6Cl2O
IUPAC Name:
2-Chloro-2-methylpropanoyl chloride
Details on test material:
- Name of test material (as cited in study report): 2-chloroisobutytylchloride
- Physical state: liquid
- Analytical purity: 97.88%
- Lot/batch No.: 012001
- Expiration date of the lot/batch: June 2011
- Stability under test conditions: stable
- Storage condition of test material: room temperature, protected from light

Test animals

Details on test animals or test system and environmental conditions:
The “In Vitro Membrane Barrier Test" use a bio-barrier membrane constructed to have physico-chemical properties similar to rat skin.

Test system

Preparation of test site:
other: bio-barrier
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 μL of the test item were placed directly atop the BIOBARRIER.
The test was performed on a total of seven BIOBARRIERS (four BIOBARRIERS for the test item; one each for the positive and negative control and one as colour control).
Observation period:
One BIOBARRIER disc was added on top of the first vial. 500 μL of the test item were applied evenly on the top of the BIOBARRIER disc and starting
time was recorded. This step was repeated for the remaining vials, staggering each start time by e.g. 10 seconds. The start time difference for each vial was subtracted from the final time to determine the net response time. As soon as a reaction had been observed, the time was recorded.
Number of animals:
None (in vitro test).

Results and discussion

Any other information on results incl. tables

The mean time, required to activate the CDS was 26.25 ± 1.18 min.

   CORROSITEX™ time [min]  colourchange  consistencychange
 Replicate 1  25:15  yes  no
 Replicate 2  25:05  yes  no
 Replicate 3  26:40  yes  no
 Replicate 4  28:00  yes  no
 Mean ± SD  26.25 ± 1.18    
       
 Positive control  2:07  yes  no
Negative control   128:00  yes  no

The test substance was compatible with the CORROSITEX™ Assay, as assessed in the qualification step. The categorization step and the classification step could be performed.

The test substance has been categorized to category 1.

A direct colour change was observed in tube A and the category was read from the CORROSITEX™ colour chart.

In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1B according to the UN GHS, as the mean time to activate the CDS was > 3 – 60 min (26.25 ± 1.18 min., category 1). The test substance is therefore assigned to Packing Group 2 and to EU Risk-Phrase R 34.

The controls confirmed the validity of the study. The test substance qualified for the CORROSITEX™ Assay, as assessed in the qualification test. The positive control activated the CDS within three minutes (2:07 min.), the negative control did not activate the CDS before 60 min. (128 min.).

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”,
subcategory 1B according to the UN GHS, as the mean time to activate the CDS was > 3 – 60 min (category 1). The test substance is therefore
assigned to Packing Group 2 and to EU Risk-Phrase R 34.
Executive summary:

In the present study the skin corrosive potential of 2-chloroisobutyrylchloride was analysed. Corrosive chemicals are, dependent on their grade of corrosivity, able to break through the biobarrier membrane employed in the “In Vitro Membrane Barrier Test

(CORROSITEX™- Assay)” and subsequently activate the underlying CDS. Hence, the time necessary to activate the CDS allows to distinguish between corrosive (C) and non-corrosive (NC) test substances.

Additionally, it is possible to assess the dermal corrosion hazard potential including the subcategorisation of corrosive substances as permitted in the UN GHS (corrosive subcategory 1A, 1B, and 1C) and the assignment to EU Risk Phrases (R35, R34, no label).

Hereby, the test item was placed atop of the bio-barrier membrane. CDS activation was assessed as a colour change or a change in consistency. The time required to activate the CDS was matched with given thresholds.

In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1B according to the UN GHS, as the mean time to activate the CDS was > 3 – 60 min (category 1). The test substance is therefore assigned to Packing Group 2 and to EU Risk-Phrase R 34.

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