Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No key irritation data is available for Resin acids and rosin acids, manganese salts (CAS# 9008-34-8) however, supportive data is available and is summarised below. In addition, key and supportive data is available for other members of the category 'Rosins and their salts'.

In a pre-guideline, pre-GLP supporting skin irritation study (BASF 1972b RSS), Resin acids and rosin acids, manganese salts (CAS# 9008-34-8) present at 12% in a formulation in a polyethyleneglycol vehicle was dermally applied to the shaved, intact and abraded skin of 6 albino rabbits under an occlusive wrap for 24 hours. The remainder of the administered formulation was described as 'poorly soluble manganese complex'. After 24 hours exposure, very slight erythema with or without edema was observed in one intact and two abraded sites. After 72 hours exposure the reactions increased, with very slight erythema with or without edema observed in the intact and abraded sites of three rabbits. In two rabbits, there was no observable response to treatment. The formulation containing 12% Resin acids and rosin acids, manganese salts caused slight effects on intact and abraded rabbit skin after 24 hour exposure under occlusive conditions. OECD Guideline 404 recommends a 4 hour exposure under semi-occlusive conditions.

 

In a pre-guideline, pre-GLP supporting eye irritation study (BASF, 1973 RSS), Resin acids and rosin acids, manganese salts (CAS# 9008-34-8) present at 12% in a formulation was administered to the eyes of 6 albino rabbits. The remainder of the administered formulation was described as 'poorly soluble manganese complex'. 30 mg of the solid formulation (corresponding to 3.6 mg of Resin acids and rosin acids, manganese salts) was applied to the eyes of 6 albino rabbits. The duration of exposure was not stated but eyes were examined and the grade of ocular reaction recorded at 24, 48 and 72 hours. No effects on rabbit eyes were observed with the solid test material containing 12% of CAS 9008-34-8.

 

The above skin and eye irritation data for Resin acids and rosin acids, manganese salts (CAS# 9008-34-8) is consistent with the dermal/ocular irritation information available for other members of the category Rosins and their salts (Divalent salts of Rosin and Hydrogenated rosin) that are not classified for skin or eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). A similar salt, Resin acids and rosin acids, magnesium salts (also a divalent cationic salt) was not classified for skin and eye irritation while the monovalent cationic salts (Resin acids and rosin acids, sodium salts and Resin acids and rosin acids, potassium salts) were classified.

Data on the category members is summarized below:

Skin irritation

The irritation potential of Rosin, hydrogenated (also known as Hydrogral, Foral AX, and Staybelite Resin-E) was evaluated based on the results of a Human Repeat Insult Patch Test (Industrial Bio-Test Laboratories Inc., 1977). Although the available study predates current regulatory guidelines, the procedure followed standard scientific methodology in effect at the time the study was conducted. There was no evidence of an irritation response in 53 male and female test subjects exposed three times per week for three weeks to 0.2 mL of a 50% solution of the test material in corn oil applied under occlusive patch for twenty-three (23) hours. The conditions of exposure were significantly more stringent than the 4-hour exposures used in current animal testing. There were no signs of test material-related irritation in any subject at any time during the study.

In a primary dermal irritation study on Hydrogenated rosin (Rosin, hydrogenated), 12 New Zealand white rabbits were dermally exposed to 0.5 gram of test substance for twenty-four (24) hours on intact (n=6) or abraded (n=6) skin (CIVO-Institutes TNO, 1982a). Animals were observed for seventy-two (72) hours. On intact skin, the test substance caused the appearance of very slight to well-defined erythema and only very slight edema following twenty-four (24) hour contact. By forty-eight (48) hours after patch removal, edema was absent and erythema was barely perceptible. Hydrogenated rosin was therefore not irritating to rabbit skin.

In a primary dermal irritation study, three male New Zealand white rabbits were dermally exposed on intact skin to 0.5 gram of Gum Rosin (Rosin)for 4 hours under semi-occlusive contact (Phycher Bio Developpement, 2010c). Animals were then observed for a period of 72 hours post-treatment. Irritation was scored by the method described in OECD Guideline 404. Except for slight erythema noted at the application site of a single rabbit one hour after termination of exposure, no signs of skin irritation (erythema and/or edema) were evident during 24-, 48-, or 72-hour examinations. Based on mean values of 0 for both erythema and edema at the 24-, 48-, and 72-hour observations, Gum Rosin was not irritating to rabbit skin.

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 (Food & Drug Research Laboratories, Inc., 1985c). Animals were then observed for a period of 72 hours post-treatment. Irritation was scored by the method of Draize. The conditions of exposure in this study were significantly more stringent, i. e., 24 hours on intact and abraded skin, than the current OECD 404 guidelines that specify a 4-hour exposure period on intact skin with a semi-occlusive dressing. 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 was not considered to be a skin irritant to rabbits.

The potential for Resin acids and rosin acids, hydrogenated, potassium salts to cause skin irritation has been evaluated in vitro and in vivo. In the in vitro investigation, the test substance was found to be inactive in a CORROSITEX™ assay (Eastman Kodak Company, 2004b); a satisfactory response was obtained with the positive and negative control substances included in the test. In the in vivo test (OECD Guideline 404), three New Zealand white rabbits were exposed to 0.5 g of Resin acids and rosin acids, hydrogenated, potassium salts for 4 hours under occluded contact with intact skin and observed for 72 hours. There were no signs of test material-related erythema or edema at any time during the study. In addition, no signs of erythema or edema were observed in a dermal toxicity study in which male and female rats were exposed to the test material under occluded contact for 24 hours (see Eastman Kodak Company, 2004b). Based on these data, Resin acids and rosin acids, hydrogenated, potassium salts is not considered to be a primary skin irritant.

Eye irritation

In a primary eye irritation study, three female New Zealand white rabbits were administered 0.1 gram of Gum Rosin (Rosin) into the conjunctival sac of one eye, the remaining eye of each rabbit serving as a control (Phycher Bio Developpement, 2010d). All treated eyes were examined and the grade of ocular reaction for each animal was recorded at 1, 24, 48, and 72 hours post-treatment. Due to the persistence of ocular reactions, the treated eye of a single rabbit was also examined and graded on Days 4, 7, and 8. Grades of ocular reactions were determined using the Scale of Weighted Scores for Grading the Severity of Ocular Lesions (standard Draize criteria). No signs of corneal irritation were evident for any treated eye at any time during the study. Iris irritation was limited to a single eye (Grade 1) at the 1-hour examination. Ocular conjunctivae reactions included redness (Grades 2-3) reversible between Days 3 and 8 and chemosis (Grades 2-3) reversible between Days 2 and 4. Discharge (Grade 2-3) was also reported early in the study. One eye was normal by Day 8 and the remaining two eyes appeared normal by 72 hours. The mean eye irritation scores (from the 24-, 48-, and 72-hour examinations) were calculated for each animal for classification purposes. Mean scores (chemosis, redness, iris lesions, and corneal opacity) reported were 1.3, 1.3, 0, and 0 for Animal #1; 0.3, 0.7, 0, 0 for Animal #2; and 0.3, 0.7, 0, 0 for Animal #3, respectively. Based on the evaluation criteria used in this study, Gum Rosin was considered to be minimally irritating to rabbit eye.

In a primary eye irritation study, 0.1 gram of UNITAC 70 (Rosin, reaction products with formaldehyde) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits (4 males, 2 females) (Food & Drug Research Laboratories, Inc., 1985d). The remaining eye of each rabbit served as a control. All eyes were examined with fluorescein and the grade of ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment using the Draize scale for scoring ocular lesions. Slight signs of irritation were seen for the cornea, iris, and conjunctiva. The mean eye irritation score was determined for each observation period. The overall mean eye irritation scores (± S. D.) out of a possible 110 points were 5.7 (± 6.1) at 24 hours, 3.0 (± 5.5) at 48 hours, and 0 at 72 hours. All treated eyes were normal by the 72-hour examinations. Based on the scoring and classification systems in the study report, the test substance was not considered to be irritating to rabbit eyes.

The potential for Resin acids and rosin acids, hydrogenated, potassium salts to cause eye irritation was evaluated after instillation into the eyes of six New Zealand White rabbits (Eastman Kodak Company, 2005b). Immediately after instillation, the eyes of three rabbits were irrigated with distilled water while the eyes of the other three rabbits were not.  There were no adverse effects on the cornea or iris in either washed or unwashed eyes. Signs of irritation in unwashed eyes included slight to severe chemosis and slight to moderate redness of the conjunctivae. Mean scores for conjunctival redness in unwashed eyes were 2 at the 24-, 48-, and 72-hour examinations. Mean scores for chemosis in unwashed eyes were 2, 2.33 and 1.33 at the 24-, 48- and 72-hour examinations, respectively. In washed eyes, signs of irritation were limited to slight redness of the conjunctivae. Irritation was fully reversible in the unwashed eyes by 7 days and in washed eyes by 72 hours. Based on the results of this study, Resin acids and rosin acids, hydrogenated, potassium salts is irritating to rabbit eye.

Monovalent cation salts of rosin and hydrogenated rosin are soluble and form alkali solutions with a pH of ~9 (e.g.in the solution/paste form in which they are marketed), and, as soaps, may have surfactant properties. The test substance is the substance with liquid driven off - a hygroscopic substance. Rosin and divalent cation salts are largely insoluble. Like Rosin, the divalent cation salts are therefore not alkaline in solution and cannot exercise surfactancy. Consequently the result of the eye irritation studies for monovalent cation salts should be considered a clearly defined exception to the general rule for the category Rosins and their salts.


Justification for classification or non-classification