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Diss Factsheets
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EC number: 271-402-3 | CAS number: 68554-12-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1 985
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- 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.
- 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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