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Administrative data

Description of key information

Two in vitro skin irritation and corrosivity studies have been conducted.
In vitro and ex vivo eye irritation studies have been conducted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 November 2009 to 09 November 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Reason / purpose:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
EPISKIN(TM) reconstituted human epidermis model.
GLP compliance:
yes (incl. certificate)
Species:
other: reconstituted human epidermis
Strain:
other: not applicable
Details on test animals and environmental conditions:
Not applicable as the test was performed in vitro.
Type of coverage:
other: test material applied directly
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
10 µl of the test material was applied to the epidermis surface.
Duration of treatment / exposure:
15 minutes
Observation period:
Not applicable
Number of animals:
The test was conducted In Vitro. Three replicate test tissues were used for the main test.
Details on study design:
TEST SITE
- Area of exposure: Whole of test tissue surface
- % coverage: 100%
- Type of wrap if used: Not applicable


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, each tissue was removed from the well of the treatment plate using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure: 15 ± 0.5 minutes.

SCORING SYSTEM: Not applicable
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
87.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 minutes. Remarks: Score is in % terms. (migrated information)

For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:

Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following table:

Criteria for in vitro interpretation

Classification

Mean tissue viability is =50%

Irritant (I) R38

Mean tissue viability is >50%

Non-Irritant (NI)


Mean OD540Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material

Material

OD540of tissues

Mean OD540of triplicate tissues

±SDof OD540

Relative individual tissue viability (%)

Relative mean viability (%)

± SD of % viability

Negative Control Material

0.932

0.879

0.053

106.0

100*

6.0

0.878

99.9

0.826

94.0

Positive Control Material

0.064

0.068

0.030

7.3

7.8

3.4

0.100

11.4

0.041

4.7

Test Material

0.851

0.772

0.088

96.8

87.8

10.0

0.678

77.1

0.788

89.6

 


SD=   Standard deviation

*=     The mean viability of the negative control tissues is set at 100%

The relative mean viability of the test material treated tissues was 87.8% after a 15 minute exposure.

        

The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: As specified in the test method.
Conclusions:
The test material was considered to be Non-Irritant.
Executive summary:

The substance has been found to be non-irritating to skin in an in vitro test using the EPISKINTMreconstituted human epidermis model.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 October 2009 to 09 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: OECD Guideline 431
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Test system:
other: reconstituted human epidermis
Type of coverage:
other: test material applied directly
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: In Vitro test
Amount / concentration applied:
50 µl of the test material was applied topically to the tissues, ensuring uniform covering of the tissues.
Duration of treatment / exposure:
3, 60 and 240 minutes
Observation period:
Not applicable
Number of animals:
The test was conducted In Vitro. Two replicate test tissues were used for the main test.
Details on study design:
TEST SITE
- Area of exposure: Whole of test tissue surface
- % coverage: 100%
- Type of wrap if used: Not applicable


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, each tissue was removed from the well of the treatment plate using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure: 3, 60 or 240 minutes


SCORING SYSTEM: Not applicable
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
146
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. Remarks: Scores in % terms. (migrated information)
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
182.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes. Remarks: Scores in % terms. (migrated information)
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
150
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 240 minutes. Remarks: Scores in % terms. (migrated information)

Mean OD540Values and Viabilities for the Negative Control, Positive Control Material and Test Material

Material

Exposure Period

Mean OD540of duplicate tissues

Relative mean % viability

Negative Control Material

240 Minutes

0.174

100*

Positive Control Material

240 Minutes

0.012

6.9

Test Material

240 Minutes

0.261

150.0

60 Minutes

0.318

182.8

3 Minutes

0.254

146.0



*=     The mean viability of the negative control tissues is set at 100%

Following the 3, 60 and 240 minute exposure periods the test material treated tissues appeared blue which was considered to be indicative of viable tissue. 

The relative mean tissue viability for the positive control treated tissues was 6.9% relative to the negative control treated tissues following the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied.

Interpretation of results:
other: Non-corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material was considered to be Non-Corrosive to the skin and accredited the EU risk phrase of No label and a UN packing group
Non-Corrosive.
Executive summary:

The test material was considered to be Non-Corrosive to the skin using the EPISKINTM in vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the requirements of the following OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro skin irritation and corrosivity studies show the substance to be non-irritant and non-corrosive to skin.

In vitro and ex vivo eye irritation studies show the substance to have the potential to cause severe ocular irritancy in vivo.


Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The available data are considered reliable and give clear results which are adequate to assign classification under CLP as H318: Causes serious eye damage. No classification is warranted for skin irritation or corrosivity.