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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:
weight of evidence
Study period:
2017-01-17 to 2017-05-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
2015-06-28
Qualifier:
according to
Guideline:
other: New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment No. 203
Version / remarks:
2014-07-11
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name (as cited in the study): Golpanol MPA
- Purity: 99.2 area%
- Batch Nr.: 85603856PO
- Batch Nr.:
- Contet: w(C5H9N) = 89.2 g/100 g
- Homogeneity: the test substance was homogeneous by visual inspection
- pH value: ca. 6
- Physical state / color: liquid / colorless, clear
- Storage conditions: room temperature

In vitro test system

Test system:
artificial membrane barrier model
Remarks:
Corrositex assay
Vehicle:
unchanged (no vehicle)
Details on test system:
The Corrositex® assay was conducted according to the methods described in the Corrositex® Instruction Manual, InVitro International, Irvine CA, USA and Transia GmbH, 35510 Butzbach, Germany 10 April 2016.

- Test kit: Corrositex®, InVitro International, Irvine CA, USA, containing: reagents required for qualification and categorization screen,
biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System.
- Fume hood: The assay was run in a fume hood
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- amount applied: single topical application of 500µL test substance

VEHICLE
- test substance was applied undiluted

NEGATIVE CONTROL
- amount apllied: 500 µL 10% citric acid

POSITIVE CONTROL
- amount applied: one pellet of sodium hydroxide
Duration of treatment / exposure:
- min. 3 minutes, max. 60 minutes (negative control)
Number of replicates:
Four vials were used for the test substance and one vial for the positive control and negative control each.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
min. 3 minutes, max. 60 minutes (negative control)
Details on study design:
ACCEPTANCE CRITERIA
1. breakthrough time for the positive control substance was in the historic control range (mean ± 2-3x standard deviations)
2. negative control was not to induce membrance breakthrough within a 60-minute observation period.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
7.01
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: breakthrough time of NaOH (solid, historical data) was 12.10 minutes.

Any other information on results incl. tables

Breakthrough times of the test substance, the negative control (NC) and positive control (PC). NB = no breakthrough within maximum observation period (60 minutes).

Test Substance

Break Through Time [min:s]

Vial 1

Vial 2

Vial 3

Vial 4

Mean

8:48

6:49

7:01

5:26

7:01

Controls:

PC: sodium hydroxide, solid

13:27

-

-

-

-

NC: 10% citric acid

NB

-

-

-

-

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria