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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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1998-06-24 to 1999-01-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- from 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- described in EC-Guideline 92/69
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- 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:
- rat
- Strain:
- other: Sprague Dawley, Him:OFA, SPF.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Forschungsinstitut für Versuchstierzucht, A-2325 Himberg, Germany
- Age at study initiation: Approximately 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: 252-282 g (male), 225 - 251 g (female)
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm x 15 cm). Wire mesh lids. Sanitization of cages once a week. Bedding material: Aspen wood chips, type "4 HV" (Finn Tapvei Oy, SF-73620 Kortteinen), autoclaved. Bedding material was changed weekly.
- Diet (e.g. ad libitum): Altromin 1314 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage).
- Water (e.g. ad libitum): Tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.
- Acclimation period: 5 respectively 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 55 (average)
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The patch was soaked with deionised water to get optimal contact with the skin.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal thoracal region, 5 x 6 cm, labelled in a relaxed animal (corresponding to an area of about 50 cm2, when the skin is slightly stretched at administration)
- % coverage: about 10 % of the estimated body surface
- Type of wrap if used: dressing (Fixomull Stretch, Fa. Beiersdorf).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- Range-finding study: 400, 894 and 2000 mg/kg bw
Main test: 2000 mg/kg bw - No. of animals per sex per dose:
- Range-finding study:
400 mg/kg bw: 1 male, 1 female
894 mg/kg bw: 1 male, 1 female
2000 mg/kg bw: 1 male 1 female
Main test:
2000 mg/kg bw: 4 males, 4 females
Both animals dosed with 2000 mg/kg in the preliminary test were included into the main study, leading to 5 males and 5 females treated with 2000 mg/kg in the main test. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight: before administration, 7 and 14 days after administration
Clinical observations: at least once per day.
Necropsy: 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight
Results and discussion
- Preliminary study:
- In a range finding study three groups of one male and one female each were dosed with 400, 894 or 2000 mg per kg body weight. All animals survived for 14 days after administration. Therefore it was decided to perform a limit-test with one dose of 2000 mg per kg body weight. Both animals,
dosed with 2000 mg/kg in the preliminary test, were included into the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: 3/5 males and 3/5 females were affected: The finding, observed earliest immediately after administration and latest 6 h after administration, was: Chromodacryorrhoea on the day of the test substance administration was attributed to the discomfort, caused
- Gross pathology:
- All animals in the main study were normal at terminal necropsy.
- Other findings:
- Sex differences: Effects on body weights were more pronounced in the females, who are considered therefore to be slightly more susceptible then the males.
Any other information on results incl. tables
Observations in life
A grade of severity was recorded where applicable (low - medium - high).
Findings |
Dose (mg/kg), sex |
No. of the affected animals |
Observation time (after administration)
First / last |
Maximum grade of severity |
No findings at any time |
2000, m |
22, 25 |
- /- |
- |
|
2000, f |
27, 28 |
- /- |
- |
Chromodacryorrhoea
|
2000, m |
21 |
0.5 h / 6 h |
low |
23 |
1 h / 2 h |
low |
||
24 |
1 h / 6 h |
low |
||
2000, f |
26 |
0.5 h / 2 h |
low |
|
29 |
2 h / 2 h |
low |
||
30 |
0.5 h / 1 h |
low |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50, dermal of Guanidine carbonate is higher than 2000 mg/kg body weight in rats.
- Executive summary:
A valid GLP-study was performed to investigate acute toxic effects of the test substance after a single dermal administration to rats. Methods and investigations were performed in conformance with OECD TG 402, 1987.
Guanidine carbonate was administered once dermally under semiocclusive conditions on an area of approximately 5 x 6 cm on the dorsal thoracal region of 5 male and 5 female Him:OFA rats (Sprague Dawley). The duration of the exposure was 24 hours. The dose was 2000 mg per kg body weight.
Body weight was measured before administration, 7 and 14 days after administration. Clinical observations were made at least once per day. Necropsy was performed 14 days after administration.
All animals survived until the scheduled termination of the study. Body weight and body weight gain were inconspicuous during the whole study in all males. A slight body weight loss in the first week was noted in one female. Another female gained only 1 g body weight in the second week. 3/5 males and 3/5 females were affected by chromodacryorrhoea on the day of application, lasting until maximum 6 h after administration. This effect was attributed to the discomfort caused by the dressing. The same signs were observed in both sexes. All animals were normal at the post mortem examination. Effects on body weights were more pronounced in the females, who are considered therefore to be slightly more susceptible than the males.
Except that the body weight gain of the females was slightly reduced, no toxic effects of the test substance were noted in life at the dose of 2000 mg/kg body weight. No mortality occurred. The LD50 of Guanidine carbonate is higher than 2000 mg/kg body weight in rats of either sex.
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