Resin acids and Rosin acids, manganese salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to generally accepted methods (similar to OECD Guideline 404) for a dermal irritation study.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

abraded and intact skin sites were exposed for 24 hours rather than a 4-hour exposure to intact skin as recommended in the guideline

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, reaction products with formaldehyde

EC Number:

293-659-0

EC Name:

Rosin, reaction products with formaldehyde

Cas Number:

91081-53-7

Molecular formula:

Unspecified

IUPAC Name:

Rosin, reaction products with formaldehyde

Details on test material:

-Identity (according to study report): UNITAC 70
-FDRL Test Article ID: 85-0693
-Physical state: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-Source: Ace Animals, Inc., Boyertown, PA, USA
-Number of animals: 6 (2 males and 4 females)
-Age: young adults
-Acclimation period: at least 5 days
-Weight at study initiation: 2.19-2.77 kg
-Housing: individually in wire mesh bottom cages
-Diet: NIH 09 Rabbit Ration, supplied by Zeigler Brothers, Gardners, PA, USA, available ad libitum
-Water: available ad libitum
-Identification: ear tags and color-coded cage cards

ENVIRONMENTAL CONDITIONS:
-Housed in environmentally-controlled rooms
-All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23.

-IN-LIFE DATES:
-Date of study initiation: 1985-09-26
-Date of study termination: 1985-09-29

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, abraded, and intact

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g of test material moistened with 0.5 mL of physiological saline; applied to two sites (one intact, one abraded) per rabbit

Duration of treatment / exposure:

24 hours

Observation period:

72 hours post-treatment

Number of animals:

6

Details on study design:

-Test site preparation:
On the day prior to dosing, the dorsal surface of each rabbit was clipped. Prior to application of the test substance, the application site on the right dorsal side was abraded with a hypodermic needle. The abrasions were made in a cross hatch pattern which penetrated the stratum corneum but did not disturb the dermis or produce bleeding. The left dorsal side was not abraded.

-Test material preparation:
The test material was ground with a mortar and pestle, then dispensed as an undiluted powder.

-Test material administration:
The test substance (0.5 g) was moistened with 0.5 mL physiological saline and applied to each of two application sites (one abraded and one intact) per rabbit. Following application, each test site was occluded with a one-inch square gauze patch and tape. The trunk of each animal was then wrapped with an occlusive binder.

-Test material exposure:
The test material was kept in contact with the skin for a period of 24 hours, at which time the wrappings were removed and any residual test material was removed by gentle wiping with clean gauze.

-Observations:
The application sites were scored for dermal irritation at 30 minutes after removal of the wrappings, and again at 72 hours post-treatment. Both application sites of each rabbit were scored separately for erythema and edema on a graded scale of 0-4 as described in Draize (1944) and listed below:

Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet red) to slight eschar formations (injuries in depth)

Edema formation:
0 - No edema
1 - Very slight edema (barely perceptible)
2 - Slight edema (edges of area well defined by definite raising)
3 - Moderate edema (raised approximately 1 mm)
4 - Severe edema (raised more than 1 mm and extending beyond the area of exposure)

-Data evaluation:
In evaluating the average irritation, individual scores for intact and abraded sites were recorded separately for each of the two scoring time intervals. The total for erythema was added to the total for edema then divided by 4 to yield the individual animal score. The mean of the six scores was calculated and this score represented the mean primary irritation score.

-Body weights:
Body weights were recorded prior to administration of the test substance. Body weights were not recorded at study termination.


Reference:
Draize JH, Woodard G & Calvery HO. 1944. Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Ther. 377-390.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24.5 and 72 hours post-dose

Score:

0

Max. score:

4

Reversibility:

other: No signs of irritation were evident during the test.

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1-6

Time point:

24/48/72 h

Remarks on result:

other: Individual animal scores not provided; only mean scores available

Results 3

Irritation parameter:

edema score

Basis:

animal: 1-6

Time point:

24/48/72 h

Remarks on result:

other: Individual animal scores not provided; only mean scores available

Irritant / corrosive response data:

For the abraded and intact skin sites, no signs of erythema or edema were evident during the study in any of the 6 rabbits.

Other effects:

There were no abnormal systemic signs noted during the observation period.

Any other information on results incl. tables

Both the abraded site and the intact site on each of the six rabbits were graded as "0" for erythema and "0" for edema at all observation periods.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Rosin, reaction products with formaldehyde (CAS No. 91081-53-7) is not a primary skin irritant when tested using a method similar to that described in OECD Guideline 404. No signs of erythema or edema were observed on rabbit skin when the test material was applied to intact and abraded skin under occluded contact for twenty-four hours.

Rosin, reaction products with formaldehyde (CAS No. 91081-53-7) is not classified for corrosion/ irritation in Annex I of Directive 67/548/EEC. Based on the absence of any signs of irritation during the study, this material is not classifiable for skin irritation 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.

Executive summary:

In a primary dermal irritation study, six young adult New Zealand white rabbits (2 males, 4 females) were exposed to 0.5 g of UNITAC 70 (rosin, reaction products with formaldehyde) applied for 24 hours under occluded contact to intact and abraded skin. Animals were then observed for a period of 72 hours post-treatment. Irritation was scored by the method of Draize (1944). Examinations at 24.5 and 72 hours post-treatment with the undiluted test substance moistened with saline indicated no signs of erythema or edema on the abraded or intact skin of the six rabbits. Based on these findings, UNITAC 70 (rosin, reaction products with formaldehyde) was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard.