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Description of key information

In a GLP compliant OECD TG 435 in vitro study the test substance was found to be corrosive to the skin.

In accordance with Column 2 of REACH Annex VIII No. 8.1 an in vivo study for skin corrosion/irritation does not have to be considered since results from the in vitro study under points 8.1.1 in Annex VII are applicable and the substance is classified for corrosive effects to the skin (H314).

In accordance with Column 2 of REACH Annex VIII No. 8.2 in vivo eye corrosion/irritation studies do not need to be conducted because the substance is classified for skin corrosion (H314).

The study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Cat 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 20 SEP 2017 to 12 OCT 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
28 July 2015
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test system:
artificial membrane barrier model
Justification for test system used:
The CORROSITEX™ Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives. The bio-barrier membrane is constructed to have physico-chemical properties similar to rat skin.
This in vitro method is permitted by the UN GHS tiered testing and evaluation strategy for the assessment and classification of skin corrosivity. Substances classified as non-corrosive shall undergo additional testing in accordance with the tiered testing strategy
Vehicle:
unchanged (no vehicle)
Details on test system:
SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes
- Components: One vial containing BIOBARRIER matrix and a micro stirbar, One vial containing BIOBARRIER diluent, Racks of seven vials filled with CDS, One tray of membrane discs plus one additional membrane disc, Qualify test tubes, Categorize test tubes and one bottle of CONFIRM reagent

WAS THE COMPATIBILITY TEST PERFORMED: yes

WAS THE TIMESCALE CATEGORY TEST PERFORMED: yes

METHOD OF DETECTION
- Indicator solution: CDS (no further information available)
- Dye(s) used: no information available

METHOD OF APPLICATION: undiluted atop the biobarrier membrane

NUMBER OF REPLICATES: 4

NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION:

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)

Category Time [min.] Time [min.] Time [min.] Time [min.]
1 0 – 3 > 3 - 60 > 60 - 240 > 240
2 0 - 3 > 3 - 30 > 30 - 60 > 60
UN GHS Subcategory 1A 1B 1C non corrosive
Packing Group 1 2 3 not applicable
Risk-Phrase R35 R34 R34 no label
Hazard Statement H314 H314 H314 no label
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 500 µL
- Concentration (if solution): 10 %

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 500 µL
- Concentration (if solution): 85 %
Duration of treatment / exposure:
Treatment until color change was observed.
Duration of post-treatment incubation (if applicable):
not applicable
Number of replicates:
4
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
1
Value:
44.08
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
2
Value:
44.03
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
3
Value:
32.83
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
4
Value:
43.33
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes

Table2:  Results of the Test Item Dispersogen SPS

 

CORROSITEX™ Time [min]

Colour Change

Consistency Change

Replicate 1

44.08

yes

no

Replicate 2

44.03

yes

no

Replicate 3

32.83

yes

no

Replicate 4

43.33

yes

no

Mean ± SD

41.07±5.50

 

 

 

 

 

 

Positive control

25.83

yes

no

Negative control

> 60

no

no

The mean time, required to activate the CDS was 41.07± 5.50 min.

Result of the Categorization test:

A direct change was observed in tube A and B and the category was read from the CORROSITEX colour chart. The chemical has been categorized to category 2 (materials with low acid/alkaline reserves).

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
In this in vitro study according to OECD TG 435 (membrane barrier test) the test substance showed corrosive effects. The mean time to activate the CDS was >30-60 min. (41.07 ± 5.50 min.).
Executive summary:

The potential of the test substance to induce skin corrosion was analysed by using the “In VitroMembrane Barrier Test (CORROSITEX™ Assay)” according to OECD TG 425 and under GLP conditions.

The test substance proved its ability to activate the CDS (chemical detection system) and was subsequently subjected to the timescale category test. The test substance was applied undiluted atop the bio-barrier membrane and the time required to activate the CDS was measured in four replicates. The mean time was compared to the given thresholds. 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.

In this study under the given conditions the test substance showed corrosive effects (mean time to activate the CDS: 41.07 +- 5.5 min).

The controls confirmed the validity of the study. The positive control activated the CDS between 3 - 60 min. (25.83 min.), the negative control did not activate the CDS before 60 min.

 

Endpoint:
skin irritation: in vivo
Data waiving:
other justification
Justification for data waiving:
other:
Interpretation of results:
corrosive
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
eye irritation: in vivo
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential of the test substance to induce skin corrosion was analysed by using the “In Vitro Membrane Barrier Test (CORROSITEX™ Assay)” according to OECD TG 425 and under GLP conditions.

The test substance proved its ability to activate the CDS (chemical detection system) and was subsequently subjected to the timescale category test. The test substance was applied undiluted atop the bio-barrier membrane and the time required to activate the CDS was measured in four replicates. The mean time was compared to the given thresholds. 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.

In this study under the given conditions the test substance showed corrosive effects (mean time to activate the CDS: 41.07 +- 5.5 min).

The controls confirmed the validity of the study. The positive control activated the CDS between 3 - 60 min. (25.83 min.), the negative control did not activate the CDS before 60 min.

 

Justification for classification or non-classification

The test substance showed corrosive effects in the in vitro membrane Barrier test. Therefore the test substance is classified as “CORROSIVE”, subcategory 1C according to the UN GHS with H 314, as the mean time to activate the CDS was >30-60 min. (41.07 ± 5.50 min.) (category 2). The test substance is therefore assigned to Packing Group 3.

Due to its corrosive properties, the test substance is also classified for Irreversible effects on the eye (Category 1, H318).