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EC number: 226-218-8 | CAS number: 5329-14-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of the experimental phase: November 26, 2009; Termination of the in-life phase: December 16, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sulphamidic acid
- EC Number:
- 226-218-8
- EC Name:
- Sulphamidic acid
- Cas Number:
- 5329-14-6
- Molecular formula:
- H3NO3S
- IUPAC Name:
- sulfamic acid
- Details on test material:
- - Name of test material (as cited in study report): SULFAMIC ACID (100%)
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: White crystalline powder
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: At room temperature
- Other:
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacologyand Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf Germany
- Age at study initiation: Approx. 7 - 9 months
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany), For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- Diet (e.g. ad libitum): The food was available ad libitum before and after the exposure period.
- Water (e.g. ad libitum): Tap water was offered daily ad libitum.
- Acclimation period: At least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (maximum range)
- Humidity (%): 30% - 70% (maximum range)
- Air changes (per hr): 15 to 20 times
- Photoperiod (hrs dark / hrs light): Rooms were lit (150 lux at approx 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.
IN-LIFE DATES
- From: December 01, 2009 To: December 16, 2009
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye, which remained untreated, served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the fine mortared test item were administered into one eye each of three animals.
The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- The test was performed initially using one animal.
As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
1 hour after instillation the eyes were rinsed with 20 mL NaCl solution. - Observation period (in vivo):
- The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 9 days after the administration. The eye reactions were observed and registered.
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 1 hour after instillation the eyes were rinsed with 20 mL NaCl solution.
- Time after start of exposure: 1 hour
SCORING SYSTEM:
Reactions were scored according to the following scheme:
CORNEA
Opacity degree of density (area most dense taken for reading)
no ulceration or opacity 0
scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
easily discernible translucent area, details of iris slightly obscured 2
nacreous areas, no details of iris visible, size of pupil barely discernible 3
opaque cornea, iris not discernible through the opacity 4
IRIS
normal 0
markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, iris reactive to light (a sluggish reaction is considered to be an effect) 1
haemorrhage, gross destruction, or no reaction to light 2
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
normal 0
some blood vessels hyperaemic (injected) 1
diffuse, crimson colour; individual vessels not easily discernible 2
diffuse beefy red 3
CHEMOSIS
Swelling: refers to lids and/or nictitating membranes
normal 0
some swelling above normal 1
obvious swelling with partial eversion of lid 2
swelling with lids about half-closed 3
swelling with lids more than half-closed 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
24 hours and 7 days after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany)).
Fluorescein-Test:
DEGREE OF STAINING
no staining 0
scattered or diffuse colouration, details of iris clearly visible 1
easily discernible translucent area, details of iris slightly obscured 2
opalescent areas, details of iris not discernible, extent of pupil difficultly determinable 3
opaque cornea, iris not discernible through the opacity 4
INVOLVED AREA OF CORNEA
none 0
up to 1/4 of the surface 1
1/4 to 1/2 of the surface 2
1/2 to 3/4 of the surface 3
3/4 to whole surface. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- In addition, secretion was observed in all animals 60 minutes to 72 hours, in animal no. 1 until 5 days after instillation.
Brown discoloured eye lids were observed in all animals 60 minutes to 48 hours, in animal nos. 2 and 3 until 72 hours after instillation. - Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Time after administration |
CORNEA |
IRIS |
CONJUCTIVAE |
|
|
Opacity |
|
Redness# |
Chemosis## |
Animal No. : 1 / 2 / 3 |
||||
right eye: 100 mg Sulfamic Acid (100%)/animal |
||||
before dosing |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
60 minutes |
1/2/2 |
1/2/2 |
1a,b/1a,b/1a,b |
2/1/2 |
24 hours |
1/2/2 |
1/2/2 |
2a,b/1a,b/2a,b |
2/2/2 |
48 hours |
1/2/2 |
1/2/2 |
2a,b/2a,b/2a,b |
1/2/2 |
72 hours |
1/4/4 |
1/2/2 |
2a/2a,b/2a,b |
1/2/2 |
4 days |
1/1/1 |
1/1/2 |
2a/2/1 |
1/1/1 |
5 days |
1/1/1 |
1/1/1 |
2a/1/1 |
1/1/1 |
6 days |
1/1/1 |
1/1/1 |
1/1/1 |
1/1/1 |
7 days |
1/1/1 |
1/0/0 |
1/1/0 |
1/1/1 |
8 days |
0/0/0 |
0/0/0 |
1/0/0 |
1/0/0 |
9 days |
0/-/- |
0/-/- |
0/-/- |
0/-/- |
# refers to palpebral and bulbar conjunctivae; excluding cornea and iris ## swelling: refers to lids and/or nictating membrane 24hoursfluorescein test: animal nos. 1 and 3:corneal staining (1/2 to 3/4 of the surface) animal no. 2: corneal staining (3/4 to wholesurface) 7 days fluorescein test: all animals: corneal staining (up to 1/4 of the surface) a secretion b eye lids brown discoloured - no examination |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: other: EC-Commission directive 67/548/EEC and its subsequent amendments
- Conclusions:
- In a GLP guideline study conducted according to EC method B.5. and OECD guideline 405, sulfamic acid demonstrated irritation in the eye of rabbits which was fully reversible 9 days post treatment. According to the criteria laid down in the Globally Harmonized System of Classification and Labelling of Chemicals, sulfamic acid is considered to be irritating to eyes.
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