Reaction mass of Resin acids and Rosin acids, hydrogenated, potassium salts and potassium [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

9 July 2010 to 6 September 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Fully guideline- and GLP compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ", 13 April 2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Regulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test". 23 July 2009.

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, Paris 22 July 2010.

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dresinate 835 A

IUPAC Name:

Dresinate 835 A

Constituent 2

Reference substance name:

Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate

IUPAC Name:

Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate

Details on test material:

Trade name: Dresinate 835.
Chemical name: Abieta DRS 835.
Supplier: Sponsor.
Batch No.: AN-0400-7B.
Appearance: Yellow-brown paste.
Purity: 25-35 % water, 65-75 % sodium salt of modified rosin.
Solubility: Soluble in the most usual organic solvents; soluble in water, in the range between 30 and 60 % of solids the solution tends to gel.
pH: 9,6.
Conditions of storage: Room temperature, in the dark.
Stability at conditions of storage: Stable.
Date of expiry: Not stated.
Date of receipt: 26 April 2010.
Label on the shipping container: Abieta DRS 835, AN-0400-7B, Dresinate 835.

Test animals

Species:

other: cell model

Strain:

other: not appropriate

Details on test animals or test system and environmental conditions:

not appropriate

Test system

Type of coverage:

other: not appropriate

Preparation of test site:

other: not appropriate

Vehicle:

water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: mean tissue viability

Basis:

mean

Time point:

other: 3 min

Score:

107.3

Reversibility:

other: not appropriate

Remarks on result:

other: see below

Results 2

Irritation parameter:

other: mean tissue viability

Basis:

mean

Time point:

other: 1 hour

Score:

71.2

Reversibility:

other: not appropriate

Remarks on result:

other: see below

Results 3

Irritation parameter:

other: mean tissue viability

Basis:

mean

Time point:

other: 1 hour

Score:

10.1

Reversibility:

other: not appropriate

Remarks on result:

other: see below

Any other information on results incl. tables

Assay acceptance criteria, validity of the test

Epiderm Skin Corrosivity Test

The mean OD of the tissues, treated with deionised water (negative control) was 1.949 after 3 minutes, and 1.907 after 1 hour of exposure, that is higher than 0.8, as required by the assay acceptance criteria.

The mean tissue viability of the 3 minutes positive control was 16.8 %, that is lower than 30 %, as required by the assay acceptance criteria.

The maximum inter tissue viability differences of the test substance treated skin discs were 4.9 % for the 3 minutes and 25.8 % for the 1 hour exposure, that is below 30 % as required by the assay acceptance criteria.

The method was acceptable as the concurrent positive and negative control and the maximum inter tissue viability differences fell within the acceptable ranges given by the protocol INVITTOX n°119 by ECVAM.

 

Epiderm Skin Irritation Test

The mean OD of the tissues, treated with deionised water (negative control) was 2.030, that is higher than 1.0 and lower than 2.5, as required by the assay acceptance criteria

The mean tissue viability of the positive control was 6.1 %, that is lower than 20 %, as required by the assay acceptance criteria.

The standard deviation calculated from individual percentual tissue viabilities of the"DRESINATE 835"treated skin discs was 0.6 %, that is below 18 % as required by the assay acceptance criteria.

The method was acceptable as the concurrent positive and negative control and the standard deviation calculated from individual percentual tissue viabilities fell within the acceptable ranges given by the protocolused during the ECVAM validation study.

Cell viability measurement

Epiderm Skin Corrosivity Test

Test substance	Mean tissue viability (%)		Prediction
	3 minutes	1 hour
"DRESINATE 835"	107.3 %	71.2 %	Non-Corrosive

 

Epiderm Skin Irritation Test

Test substance	Mean tissue viability (%)	Prediction
"DRESINATE 835"	10.1 %	Irritant

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the results of this study, the Directive 2001/59/EC and the GHS, the test substance is considered to be non-corrosive but irritant to skin.

Executive summary:

Aim and Method

The EpiDerm Skin Corrosivity/Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of "DRESINATE 835".

As the pH determination showed a pH of 9.53, no alkaline / acid reserve was determined.
The test substance wastopically applied for 3 minutes and 1 hour to the epidermal surfaces ofthree-dimensional human epidermis models, followed by immediate determination of the cytotoxic effect. As there was no corrosive effect observed, the test substance wastopically applied for 60 minutes to the epidermal surfaces ofthree-dimensional human epidermis models. After a post-incubation of 42 hours, a cell viability test was performed.  Investigations performed were in conformance with theRegulation (EC) 440/2008: B.40.BIS. "In vitro skin corrosion: human skin model", theOECD-Guideline 431, "In Vitro Skin Corrosion: Human Skin Model Test ",, the OECD Guideline “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”,, the ESAC statement,and theRegulation (EC) 761/2009: B.46 "In vitro skin irritation: Reconstructed Human Epidermis Model Test"..

Results

EpiDerm Skin Corrosivity Test

Assay acceptance criteria according to the protocol INVITTOX n°119 by ECVAM:

·      The mean optical density (OD) of the tissues, treated with deionised water (negative control) was 1.949 after 3 minutes, and 1.907 after 1 hour of exposure, that is higher than 0.8, as required by the assay acceptance criteria.

·      The mean tissue viability of the 3 minutes positive control was 16.8 %, that is lower than 30 %, as required by the assay acceptance criteria.

·      The maximum inter tissue viability differences of the "DRESINATE 835" treated skin discs were 4.9 % for 3 minutes and 25.8 % for 1 hour exposure, that is below 30 % as required by the assay acceptance criteria.

"DRESINATE 835":

·      The mean percentage viability of the treated skin discs after 3 minutes of exposure was 107.3 % which is above the threshold of 50 % for classification.

·      The mean percentage viability of the treated skin discs after 1 hour of exposure was 71.2 % which is above the threshold of 15 % for classification.

EpiDerm Skin Irritation Test

Assay acceptance criteria:

·      The mean OD of the tissues, treated with deionised water (negative control) was 2.030, that is higher than 1.0 and lower than 2.5, as required by the assay acceptance criteria.

·      The mean tissue viability of the positive control was 6.1 %, that is lower than 20 %, as required by the assay acceptance criteria.

·      The standard deviation calculated from individual percentual tissue viabilities of the "DRESINATE 835" treated skin discs was 0.6 %, that is below 18 % as required by the assay acceptance criteria.

"DRESINATE 835":

·      The mean percentage viability of the treated skin discs was 10.1 % which is below the threshold of 50 % for classification.

Conclusion

According to the results of this study, the Directive 2001/59/EC and the GHS, the test substance "DRESINATE 835" is considered to be non-corrosive but irritant to skin.