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EC number: 285-077-0 | CAS number: 85029-52-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 21/07/2006 to 02/08/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP compliance and International Guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Guideline for testing of chemicals Acute Eye Irritation/Corrosion
- GLP compliance:
- yes
Test material
- Reference substance name:
- ACQUAPOL C1
- IUPAC Name:
- ACQUAPOL C1
- Test material form:
- other: liquid
- Details on test material:
- Test article: ACQUAPOL C1
Form: Aqueous solution of quaternary ammonium tannate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test system:
Adult white albino rabbits (Oryctolagus cuniculus) of the New Zealand breed, weighing 1850-2200 gramsof live weigh, were used. the animals were healty and had no detectable pathological changes in the skin.
Environmental condition:
The animals were acclimated to the laboratory conditions at least 5 days prior to the beginning of the experiment. They were kept with ventilation of 10 to 15 air changes per room per hour and a photoperiod of 12 hours in the light and 12 hours in the dark. The diet comprised commercial pelletized feed, with supplemetnation of filtered water, both provided ad libitum. 3 animals were used, 3 males, which were kept individually in galvanized wire cages.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: test system used as control
- Amount / concentration applied:
- The test article Acquapol C1, originally in liquid form, was used pure. The total amount of the solution applied to the skin in each animal was 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours before the beginning of the test, the hair in the region immediately posterior to the back of the neck were removed using shears for animals, with great care not to hurt and/or irritate the skin. The solution were applied to the small sheared area (approximately 6 cm2) on the back of the animals, and then protected by a gauze/occlusive patch. The untreated adjacent areas served as negative control. At the end of the exposure period (4 hours), the solution residues were removed by rising with water with the aid of cotton. The animals were maintained for 72 hours under observation, being clinically observed. and the lesion grades were noted ast 60 minutes, 24 hours, 48 hours and 72 hours after the application of the product. The animals were examinated for the presence of herythema, edema and formation of eschars, as well as other local or systemic changes.
Analysis of the results:
Each animal was separately evaluated and their results were put into individual table. The degrees of skin lesions were recorded in accordance with the scale in Table 1
Calculation of the skin irritation index:
To estabilish the Skin Irritation Index, the values for erythema and formation of eschars for 24 and 72 hours (2 values) were added to the values for edema formation for 24 and 72 hours (2 values). The total of these 4 values were divide by 2 and classified according to the criterion in table 2.
the edema evaluation was measured through paquimeter, and the calculation of the value of the edema was made through the formula:
(Lat/2) - (Lac/2) = Edmm
Lat= reading of the area tests (entire and with groove)
Lac= reading of the control area (entire and with groove)
Edmm= Value of the edema in millimeters
The graduation of the intensity of the cutaneous reaction was based in the method of Draize, according to the table 1
The calculation of the value of primary cutaneous irritation is accomplished through the toally of the aritmetic average divided by four of the following observations:
- Edema in the entire skin 24:00 hours
-Edema in the skin with groove 24:00 hours
- Eritema in the entire skin 24:00 hours
-Eritema in the skin with groove 24:00 hours
- Edema in the entire skin 24:00 hours
-Edema in the skin with groove 72:00 hours
- Eritema in the entire skin 72:00 hours
-Eritema in the skin with groove 72:00 hours
Classification class are defined in table 2
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Skin Irritation Index:
Animal 1: 0, 0
Animal 2: 0, 0
Animal 3: 0,0
Average:0, 0
Classification: Non-irritative Clas IV: No irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The concerning substance is consider non-irritant when applied on the skin and according to Reg.Ec 1272/2008
- Executive summary:
The Primary Skin Irritation Test on rabbits, based on OECD guideline 404, is intended for providing information on the corrosive or irritative effects of a substance on the skin of mammals. The concerning substance showed a skin irritation index 0.0 and is consider non-irritant when applied on the skin in rabbits according to Reg.EC 1272/2008.
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