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EC number: 209-813-7 | CAS number: 593-85-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1998-07-21 to 1999-01-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diguanidinium carbonate
- EC Number:
- 209-813-7
- EC Name:
- Diguanidinium carbonate
- Cas Number:
- 593-85-1
- Molecular formula:
- CH5N3.1/2CH2O3 (one guanidine species, as denoted in the ESIS database) CH5N3.CH5N3.CH2O3 (as in the crystalline from, basis for the molecular weight 180.1658 g/mol as given below)
- IUPAC Name:
- bis(amino(imino)methanaminium) carbonate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Guanidine Carbonate Pure
- Substance type: Salt with organic kation and inorganic anion
- Physical state: White crystalline powder
- Analytical purity: 99.7 %
- Impurities: Sulphate ash <0.05 %, heavy metals calculated as lead, <10 ppm (mg/L), iron 1 ppm, lead <1 ppm, arsenic <3 ppm
- Purity test date: 1998-06-09
- Lot/batch No.: 1867 of Agrolinz Melamin GmbH, St.-Peter-Strasse 25, A-4021 Linz
- Expiration date of the lot/batch: Not specified but considered stable under conditions of storage for at least 5 years
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Schitkovits, A-2620 Natschbach.
- Age at study initiation: not reported
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm x 35 cm.
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum. Random samples of the feed are analysed for contaminants by Altromin, D-32791 Lage.
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (average)
- Humidity (%): 60 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The hair was clipped on the dorsal area of the trunk one day before the application.
- Vehicle:
- water
- Remarks:
- Samples of the test item were moistened with distilled water.
- Controls:
- other: Surrounding untreated skin was taken as a control area.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): Samples of the test item were moistened with distilled water. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days. Observations were made 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: The test item samples were placed on cellulose patches (pure Zellin swap, Hartmann, Wiener Neudorf) and fixed marginally (Blenderm R surgical tape, hypoallergenic 3M). The application sites were covered semi-occlusive by dressing (self adhesive non woven fabric, hypoallergenic, Beiserdorf)
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was removed with wet Kleenex tissues, if necessary
- Time after start of exposure: After 4h exposure (Thus the duration of the exposure was 4 hours.)
SCORING SYSTEM:
Erythema / Eschar formation
0: No erythema.
1: Very slight erythema (barely perceptible).
2: Well-defined erythema.
3: Moderate to severe erythema.
4: Severe erythema (beet redness) or eschar formation (injuries in depth).
Oedema formation
0: No oedema.
1: Very slight oedema (barely perceptible).
2: Slight oedema (edges of area well defined by definite raising).
3: Moderate oedema (raised approximately 1 mm).
4: Severe oedema (raised more than 1 mm and extending beyond area of exposure).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
No general toxic effects were noted and all areas treated with the test substance and all control areas were normal before the
application and at each observation time.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance Guanidine carbonate did not cause any adverse skin reactions in this study.
- Executive summary:
The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of New Zealand White rabbits. Methods and investigations were performed in conformance with the OECD TG 404.
Approximately 0.5 g Guanidine carbonate, moistened with distilled water, was applied via a patch to an area of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours.
The body weight was measured at the start and at the termination of the test. The animals were observed for general signs of toxicity once daily and the skin was examined 1, 24,48 and 72 h after patch removal.
No general toxic effects were observed. All exposed skin sites were normal at each examination term. In all animals mean scores for erythema as well as for oedema formation, calculated from the examinations performed 24,48 and 72 hours after patch removal, were "0", i.e. normal. The test substance did not cause any adverse skin reactions in this study.
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