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Administrative data

Description of key information

skin:
The test substance showed a corrosive potential in an in vitro skin corrosion test.
eyes:
The test substance was corrosive to the rabbits' eyes in an eye irritation study.

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:
key study
Study period:
2014-04-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and Guideline Study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
2006
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): appr. 500 μL
Duration of treatment / exposure:
not applicable
Observation period:
not applicable
Number of animals:
not applicable
Irritation / corrosion parameter:
other:
Value:
2.34
Remarks on result:
other:
Remarks:
Basis: other: mean of 7 vials. Time point: break through times. (migrated information)
Irritant / corrosive response data:
Corrosive potential was determined on the basis of the average time recorded for the test substance to produce a change in the CDS.
Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl was applied to the other eye of the same animals
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
1 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Reversibility:
not reversible
Remarks on result:
other: corrosion was observed in treated eyes of both animals
Irritant / corrosive response data:
Already 1 hour after instillation of the test substance, greyish-brown corrosion of the conjunctiva, cornea and eyelids.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The potential of 1-Methylpyrrolidine to cause dermal corrosion was assessed by a single topical application of 500 μL of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay). The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). In addition to the test substance a positive and a negative control were assessed. Two test runs were performed. The Corrositex® assay showed the following results: The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance. A timescale category test was carried out to distinguish between weak and strong acids or bases. The test substance was assigned to timescale category 1 (having a high acid/alkaline reserve). In each test run four Corrositex® Biobarrier Membranes were treated with the test substance. In the first test run one of the four membranes treated with the test substance showed a distinctly longer breakthrough time than the other three membranes. A technical fault was considered to be the reason. In order to verify the result of the first test run, a second test run was performed. In the second test run all four membranes showed break through times in the range of the three valid membranes of the first test run. The mean breakthrough time of the test substance, considering the valid membranes of both test runs of the Corrositex® assay, was 2 minutes and 34 seconds. Based on the observed results it was concluded, that 1-Methylpyrrolidine shows a corrosive potential in the Corrositex® -Skin Corrosion Test under the test conditions chosen.The mean breakthrough time determined in the in vitro membrane barrier test was 2 minutes and 34 seconds.

Additionally, a study is available in which 1 mL of the test substance was applied to the skin of 2 rabbits each for exposure times of 1 min, 5 min and 15 min. After an observation time of 8 days the treated skin sites showed necrotic changes and thus indicate at least a severe irritation of the skin.

Eyes

0.05 mL of the test substance were applied to one eye of two rabbits. The other eye served as control where NaCl was applied. After 1 hour, the eyes treated with test substance exhibited corrosion.


Justification for selection of skin irritation / corrosion endpoint:
most reliable study available

Justification for selection of eye irritation endpoint:
only one study available

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as corrosive C, R35 (causes severe burns) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified as corrosive category 1A, H314 (Causes severe skin burns and eye damage) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 605/2014.