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Registration Dossier
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Diss Factsheets
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EC number: 268-608-0 | CAS number: 68131-04-4
- 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://chesar.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
- Study period:
- from August 21, 2007 to September 10, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- short term temperature change
- Principles of method if other than guideline:
- Increasing of temperature of animals room (up to 26.1°C). The limit (in EU Method B.4) for temperature is 20 ± 3°C. The deviation from the limit was short-term and did not influence the wellness of animals and the study results.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Humic acids, sodium salts
- EC Number:
- 268-608-0
- EC Name:
- Humic acids, sodium salts
- Cas Number:
- 68131-04-4
- Molecular formula:
- NA
- IUPAC Name:
- Humic acids, sodium salts
- Details on test material:
- - Name of test material (as cited in study report): Humic acids, sodium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 9. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Weight at study initiation: 3.9-4.2 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17 - 23ºC, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: close clipping of the fur on the dorsal area
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with the smallest amount of water)
- Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours (one animal)
4 hours (2 animals) - Observation period:
- 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: fur from area 6x6 cm was removed
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: by water
- Time after start of exposure:
1st patch - 3 minutes
2nd patch - 1 hour
3rd patch - 4 hours
SCORING SYSTEM: Exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Scoring system - see Table 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No evidence of a irritation/corrosion on the skin.
- Other effects:
- No symptoms systemic toxicity.
No mortality.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritation was caused by 4-hour exposure.
- Executive summary:
The test substance was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.
Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Directive 2004/73/EC, published in O.J. L 152, 2004.
Three rabbits were exposed to of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing.
Skin reactions were evaluated after patch removal and observations were made 1, 24, 48 and 72 hours after exposure.
No other signs of intoxication were observed.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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