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EC number: 244-343-6 | CAS number: 21351-39-3
- 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:
- end on 30-MAY-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Uronium hydrogen sulphate
- EC Number:
- 244-343-6
- EC Name:
- Uronium hydrogen sulphate
- Cas Number:
- 21351-39-3
- Molecular formula:
- CH4N2O.H2O4S
- IUPAC Name:
- hydrogen [amino(hydroxy)methylidene]azanium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Lower-7/Acid Flow/Enquik
- Substance type: monoconstituent substance
- Physical state: liquid
- Stability under test conditions: data not available
- Storage condition of test material: room temperature in darkness
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja San Bernardo, SL (Tulebras, Navarra)
- Age at study initiation: approximate age of 11-12 weeks
- Weight at study initiation: 2.8-3.2 kg
- Housing: the rabbits were housed individually in stainless steel cages (52.0 x 58.0 x 43.0 cm) placed on shelves and equipped with slatted floors.
- Diet: free access to a standard diet for rabbits Panlab 112
- Water: ad libitum
- Acclimation period: a minimum period of seven days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-25 ºC
- Humidity: 30-65%
- Air changes: data not avaiable
- Photoperiod: 12 hours of light (7:00 to 19:00) and 12 hours of darkness every 24 hours
IN-LIFE DATES: data not available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: data not available
- Type of wrap if used: semi-occlusive patches used were fixed with a band or adhesive micro-porous hypoallergenic
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: after exposure with distilled water
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- It initially used a single animal (no. 1995), sequentially applying three dressings. The first dressing was removed after three minutes. After no serious skin reaction, it was applied a second dressing, which was retired after 1 hour. There was no serious skin reaction to either remove the second pack, so it was applied a third, which was removed at 4 hours d exposure.
At 60 minutes, at 24, 48 and 72 hours, 7 and 14 days after removal of patches exposed for 3 minutes and 1 hour respectively, there were no injuries in the area administered.
At 60 minutes after removing the patch exposed for four hours, it was observed well-defined erythema (grade 2) with slight edema (grade 2). At 24 hours after removal of the patch, there was very slight erythema (grade 1) accompanied by very slight edema (grade 1). At 48 and 72 hours after removal of the patch exposed for four hours the edema had complete remission, although there was again well-defined erythema (grade 2), which decreased to very slight edema (grade 1) during the observation at 7 days after removal of the patch. No skin changes were observed at 14 days after removing the patch in this animal, except slight scaling.
Subsequently it was applied to two animals (no. 2004 and 2005) a dressing with the test, it was was removed after 4 hours of exposure.
At 60 minutes after removing the patch, in one of these two animals (no. 2004) was recorded very slight erythema (grade 1) with very slight edema (grade 1). At 24, 48 and 72 hours in this animal was observed very slight erythema (grade 1). At 7 and 14 days after removing the patch, there were no skin lesions in this animal, although there was slight scaling during the observation at 7 days.
At 60 minutes after removing the patch, in the remaining animal (No. 2005) showed well defined erythema (grade 2) with slight edema (grade 2). At 24, 48 and 72 hours in this animal was recorded very slight erythema (grade 1), with very slight edema (grade 1) only in the reading performed at 24 hours. At 7 days after removing the patch, there were no skin lesions in this animal.
Mean ratings of erythema and edema at 24, 48 and 72 hours of the three animals after a 4-hour exposure were 1.22 (erythema) and 0.22 (edema). - Other effects:
- The behavior and physical condition of the rabbits, and the evolution of body weight was normal during the study.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
2 / 1 / 2 |
2 / 1 / 2 |
24 h |
1 / 1 / 1 |
1 / 0 / 1 |
48 h |
2 / 1 / 1 |
0 / 0 / 0 |
72 h |
2 / 1 / 1 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
1.7 / 1 / 1 |
0.3 / 0 / 0.3 |
7 days |
1 / 0 / 0 |
0 / 0 / 0 |
14 days |
0 / 0 / - |
0 / 0 / - |
Reversibility*) |
yes |
yes |
Average time for reversion |
14 days |
48 hours |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Urea sulphate is not considered as irritant to the skin.
- Executive summary:
In a primary dermal irritation study (OECD 404, GLP), young adult New Zealand White rabbits (3 animals) were dermally exposed to 0.5 mL of undiluted Lower-7/Acid Flow / Enquik (Uronium hydrogen sulphate) for 4 hours under semi-occlusive conditions. Animals then were observed for 14 days. Irritation was scored by the method cited in OECD guideline.
Mean ratings of erythema and edema at 24, 48 and 72 hours of the three animals after a 4-hour exposure were 1.22 (erythema) and 0.22 (edema).
In this study, Lower-7/Acid Flow / Enquik (uronium hydrogen sulphate) is not a dermal irritant. Classification is not required according to EU legislation (DSD or CLP).
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