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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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
- Test material form:
- solid: crystalline
- Details on test material:
- White crystals
Purity = 99.85%
Impurity: SO4 = 0.02%; H2O = 0.02%; FE = 0.0003%; PB = 0.0003%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation:Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
- Weight at study initiation: See Table 2.
- Health conditions: A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean of 22°C +/- 3 °C (continuous control and recording).
- Humidity (%): Mean of 30 – 70 % (continuous control and recording).
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light):Artificial light from 6 a.m. to 6 p.m.
- Cages:Single caging in Makrolon cages type III (37.5 cm x 21.5 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Bedding material:Aspen wood chips, Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved. Random samples of the bedding material are analysed for contaminants by the supplier. Changes 1 / week.
- Environmental enrichment:Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals once a week.
- Feed: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff.
- Water:Tap water, from an automatic watering system, ad libitum.
Random samples of the water are analysed by the "AGES",
A-1226 Vienna, to check, if the water fulfils the requirements for drinking water for humans.
-Identification:Labelling with felt-tipped pen on the tail and on the cage.
-Acclimatisation: At least 7 days.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- "SULPHAMIDIC ACID" was administered once topically on an area of approximately
6.5 cm x 8 cm on the dorsal thoracic region of 5 male and 5 female Sprague Dawley rats.
The dose was 2000 mg per kg body weight.
A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape.
The test site was covered by a semi-occlusive dressing.
The duration of the exposure was 24 hours. - Duration of exposure:
- The duration of exposure was 24 hours.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: yes
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
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: See Table 3. General findings: All animals did not show any clinical signs during the entire observation period. Observations of skin condition: Exposed skin was not found to be altered by the test substance.
- Gross pathology:
- See Table 4.
No abnormal findings were made in the animals at terminal necropsy. - Other findings:
- Sex differences:
No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.
Any other information on results incl. tables
Table1: Synopsis of the results
Sex |
Animal |
Dose |
Number of animals |
||
|
Nos. |
(mg / kg b.w.) |
exposed |
affected |
deceased |
m |
321-325 |
2000 |
5 |
0 |
0 |
f |
326-330 |
2000 |
5 |
0 |
0 |
Table2: Body weights and body weight gain.
Individual data, mean and standard deviation SD.
Dose |
Animal |
Body weight (g) |
Body weight gain (g) |
||||
Sex |
No. |
before |
7 days |
14 days |
death |
0-7 days |
7-14 days |
|
321 |
293 |
340 |
388 |
- |
47 |
48 |
2000 mg/kg |
322 |
278 |
335 |
378 |
- |
57 |
43 |
male |
323 |
289 |
312 |
347 |
- |
23 |
35 |
|
324 |
289 |
328 |
378 |
- |
39 |
50 |
|
325 |
271 |
296 |
331 |
- |
25 |
35 |
|
mean |
284.0 |
322.2 |
364.4 |
- |
38.2 |
42.2 |
|
SD |
9.2 |
18.1 |
24.2 |
- |
14.5 |
7.0 |
|
326 |
242 |
254 |
268 |
- |
12 |
14 |
2000 mg/kg |
327 |
253 |
253 |
261 |
- |
0 |
8 |
female |
328 |
229 |
230 |
234 |
- |
1 |
4 |
|
329 |
234 |
241 |
252 |
- |
7 |
11 |
|
330 |
233 |
235 |
246 |
- |
2 |
11 |
|
mean |
238.2 |
242.6 |
252.2 |
- |
4.4 |
9.6 |
|
SD |
9.5 |
10.7 |
13.2 |
- |
5.0 |
3.8 |
Table3: Observations in life.
Findings |
Dose |
No. of the affected animals |
Observation time |
Maximum grade of severity |
no clinical signs |
2000 m |
321, 322, 323, 324, 325 |
0 h / 14 d |
- |
|
2000 f |
326, 327, 328, 329, 330 |
0 h / 14 d |
- |
Table4: Necropsy findings.
SYSTEM |
Dose |
No. of affected |
no abnormal findings |
2000, m |
321, 322, 323, 324, 325 |
|
2000, f |
326, 327, 328, 329, 330 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No local or systemic test substance related effects were noted from clinical observations or post-mortem examination at a dose of 2000 mg test substance per kg body weight. Therefore, the LD50 (dermal, rat) is >2000 mg/kg bw.
- Executive summary:
No local or systemic test substance related effects were noted in this limit test for acute dermal toxicity, applying 2000 mg/kg bw semiocclusively. Clinical observations and post-mortem examination did not reveal any test substance related effects. Therefore, the LD50 (dermal, rat) is >2000 mg/kg bw.
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