Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [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: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 12 OCT 2004 to 15 OCT 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 404, EU Method B.4, and GLPs.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, hydrogenated, potassium salts

EC Number:

273-572-4

EC Name:

Resin acids and Rosin acids, hydrogenated, potassium salts

Cas Number:

68990-01-2

IUPAC Name:

resin acids and rosin acids, hydrogenated, potassium salts

Details on test material:

-Test material (as cited in report): Resin acids and Rosin acids, hydrogenated, potassium salts
-Batch/Lot number: X29363-079
-Physical state: Solid tan chunks
-Supplier: Eastman Chemical Company, Kingsport, Tennessee, USA

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-Source: Covance Research Products, Inc., Denver, PA
-Sex: not specified
-Acclimation period: 5 days
-Age at study initiation: at least 3 months old
-Housing: rabbits were individually housed in suspended, stainless-steel, wire-mesh cages
-Diet: Certified High Fiber Rabbit Diet (PMI #5325); ad libitum
-Water: local municipality, ad libitum
-Method of animal identification: uniquely-numbered ear tags and cage cards

ENVIRONMENTAL CONDITIONS:
-Temperature (°C): 21.1-23.3
-Humidity (%): 43.2-61.9
-Photoperiod: 12 hours light/12 hours dark cycle

IN-LIFE DATES:
-Experimental start date: 2004-10-12
-Experimental completion date: 2004-10-15

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin adjacent to the test site served as the control for each animal.

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours after removal of the occlusive patch

Number of animals:

3

Details on study design:

PRE-TEST ACTIVITIES:
Prior to initiation of the dermal irritation study, a screening procedure was performed. First the pH of the test substance was measured and the value obtained (10.307) demonstrated that the test substance was neither strongly acid (pH ≤ 2.0) nor strongly alkaline (pH ≥ 11.5). Subsequently, an in vitro test (Corrositex Assay) designed to identify substances that are corrosive to the skin was conducted. The results of this test suggested that the test substance was non-corrosive.

APPLICATION OF TEST SUBSTANCE:
Prior to treatment, an area of the dorsal skin was shaved with an electric clipper. The test substance was moistened thoroughly with water and a single dose of 0.5 g of the test substance was applied to the shaved area with a fiber pad. An occlusive wrap was applied to hold the test substance in contact with the skin for four hours. After 4 hours, the bandage was removed and the application site rinsed with running water.

OBSERVATIONS:
The site of application was examined at 1, 24, 48, and 72 hours after removal of the occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and stains caused by the test substance as well as general systemic effects. At the end of the observation period, the animals were euthanized and discarded without necropsy.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: all timepoints

Score:

0

Max. score:

4

Remarks on result:

other: No erythema was noted in any animal at any timepoint.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: all timepoints

Score:

0

Max. score:

4

Remarks on result:

other: No edema was noted in any animal at any timepoint.

Irritant / corrosive response data:

No erythema or edema was noted in any animal at any time during the study.

Other effects:

No toxicity or abnormal behaviors were noted in any animal during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Resin acids and Rosin acids, hydrogenated, potassium salts is not a primary skin irritant. No signs of erythema or edema were observed on rabbit skin when the test material was applied to intact skin under occluded contact for 4 hours.

Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for Skin Irritation/Corrosion according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for skin irritation in Annex I of Directive 67/548/EEC.

Executive summary:

In a dermal irritation study, three New Zealand White rabbits were each exposed to 0.5 g of Resin acids and Rosin acids, hydrogenated, potassium salts moistened with water and applied to the shaved skin of the back for four hours under occluded contact. After removal of the occlusive dressings, the animals were observed for a total of 3 days for signs of primary irritation (erythema and edema). During the observation period, the test substance did not cause any erythema or edema. Under the study conditions, Resin acids and Rosin acids, hydrogenated, potassium salts is not considered to be a skin irritant in New Zealand White rabbits.