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Description of key information

In the in vitro EPISKIN model test with Aldehyde M the results indicated that the test item was corrosive to skin at 4 hours and not corrosive after 1 hour and 3 min of exposure. Therefore, no skin irritation and eye corrosion study in vitro was conducted. 

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:
2013-03-20 to 2013-05-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD/EU guideline.
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
13 April 2004
Deviations:
no
Qualifier:
according to
Guideline:
other: B.40Bis: In Vitro Skin Corrosion: Human Skin Model Test, 31 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
other: EPISKIN Standard Model
Strain:
other: EPISKIN Standard Model
Details on test animals and environmental conditions:
not applicable
Type of coverage:
other: The test item was topically applied on the epidermal surface of test skin units
Preparation of test site:
other: The epidermis units were preincubated overnight at 37 °C in an incubator.
Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls, respectively.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 50 µL of the unchanged test substance per epidermis unit
Duration of treatment / exposure:
1st Experiment: 4 hours at room temperature
2nd Experiment: 1 hour at room temperature
3rd Experiment: 3 min at room temperature
Observation period:
not applicable
Number of animals:
Two EPISKIN model units per experiment
Details on study design:
TEST SITE
- Area of exposure: epidermal surface of skin unit (0.38 cm2 per unit)

REMOVAL OF TEST SUBSTANCE
- Washing: PBS 1 x solution
- Time after start of exposure: 4 hours, 1 hour and 3 min after treatment, respectively.

SCORING SYSTEM: Cell viability
Irritation / corrosion parameter:
other: other: Cell Viability
Value:
31
Remarks on result:
other:
Remarks:
Basis: mean Two skin units. Time point: 4 hours. Remarks: (% control). (migrated information)
Irritation / corrosion parameter:
other: other: Cell viability
Value:
120
Remarks on result:
other:
Remarks:
Basis: mean Two skin units. Time point: 1 hour. Remarks: (% control). (migrated information)
Irritation / corrosion parameter:
other: other: Cell viability
Value:
110
Remarks on result:
other:
Remarks:
Basis: mean Two skin units. Time point: 3 minutes. Remarks: (% control). (migrated information)
Irritant / corrosive response data:
The test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours exposure. No reduction of viability was observed after 1 hour and 3 minutes exposure.
Other effects:
Possible direct MTT reduction with test substance:
No colour change was observed after three hours of incubation. The test material did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability can be precluded.

Colouring potential of test substances:
The test item showed no ability to become coloured in contact with water, therefore additional controls and data calculations were not necessary. A false estimation of viability can be precluded.
Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, in this in vitro EPISKIN model test with Alehyde M the results indicated that the test item is corrosive to skin at 4 hours and not corrosive after 1 hour and 3 min of exposure.
Executive summary:
The purpose of this study was to determine the skin corrosion potential of the test item Aldehyde M on reconstituted human epidermis in the EPISKIN model in vitro.

Disks of EPISKIN (two units / chemical / incubation time) were treated with test item and incubated for 4 hours, 1 hour and 3 min at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue, viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control.

The test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours exposure. No reduction of viability was observed after 1 hour and 3 minutes exposure. The mean test item treated tissue viabilities were 31 % at 4 hours, 120 % at 1 hour and 110 % at 3 minutes of exposure. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

In this in vitro EPISKIN model test with Aldehyde M the results indicated that the test item was corrosive to skin at 4 hours and not corrosive after 1 hour and 3 min of exposure. Based on the results above the test item Aldehyde M is classified as Corrosive 1C (EU (EC n° 1272/2008 CLP)) or Corrosive class R34 (EU (67/548/EEC)) or Corrosive class III (UN).

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The purpose of the study was to determine the skin corrosion potential of the test item Aldehyde M on reconstituted human epidermis in the EPISKIN model in vitro.

Disks of EPISKIN (two units / chemical / incubation time) were treated with test item and incubated for 4 hours, 1 hour and 3 min at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue, viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control.

The test item showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours exposure. No reduction of viability was observed after 1 hour and 3 minutes exposure. The mean test item treated tissue viabilities were 31 % at 4 hours, 120 % at 1 hour and 110 % at 3 minutes of exposure. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

In this in vitro EPISKIN model test with Aldehyde M the results indicated that the test item was corrosive to skin at 4 hours and not corrosive after 1 hour and 3 min of exposure. Based on the results above the test item Aldehyde M is classified as Corrosive 1C (EU (EC n° 1272/2008 CLP)) or Corrosive class R34 (EU (67/548/EEC)) or Corrosive class III (UN).

According to column 2 of REACh Regualtion Annex VII the study for skin and eye irritation can be waived as the test item causes severe skin burns and is classified as skin corrosive, cat. 1C according to Regulation (EC) No 1272/2008.

 


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the available experimental data the test item is classified and labelled as skin corrosive, cat. 1C according to Regulation (EC) No 1272/2008 and R34 according to Directive 67/548/EEC.