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EC number: 411-410-8 | CAS number: 118562-73-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-09-19 to 1990-11-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test according to OECD guideline 401 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- HYDROXYAMBRAN
- IUPAC Name:
- HYDROXYAMBRAN
- Test material form:
- solid: crystalline
- Details on test material:
- Hydroxyambran
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals:
Species: rat
Strain: Crl.: (WI)BR – Wistar, white
Source: Firma Charles River wiga, Sandhofer Weg 7, 8714 Sulzfeld
Date of receipt August 29, September 19 and October 04, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with colored markings; cage labelled with dosage, sex, date of study initiation, project no.
Weight range at
study initiation: m: 216 – 247 g; f: 196 – 227 g
Husbandry:
Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 21 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum*
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-R, Alleindiät
Form: Pellets
Water: Administration: ad libitum
System: drinking bottles
Quality: Drinking water as for human consumption
Quality control: half-yearly analyses and bacteriological tests
*The animals were fasted from 16 h before until 3-4 h after administration of the test article.
Prior to study initiation, the animals were acclimated to laboratory conditions for at least 7 days. Only healthy animals were used in the test.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Details on oral exposure:
- The test article was administered as a dilution of 50 % in vegetable oil. The pH value was 5.5.
A single oral administration of the test article was perfomed by gavage using a stomach tube. - Doses:
- 10 000 mg/kg body weight
- No. of animals per sex per dose:
- Range finding (preliminary study): 2 female animals
Main test: 5 male and 5 female animals - Control animals:
- no
Results and discussion
- Preliminary study:
- There were no deaths in the preliminary study with 10 000 mg/kg bw.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the course of main study.
- Clinical signs:
- Abnormal clinical signs such as reduced activity, abnormal gait, abdominal position, reduced grip strength and limb tone and piloerection were observed within 1h - 48h p.a.
- Body weight:
- Weight gains were normal in all animals.
- Gross pathology:
- Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.
Any other information on results incl. tables
Body weights:
Individual Values:
Animal No. |
Sex |
Day 0 |
Day 7 |
Day 14 |
1 |
m |
247 |
290 |
330 |
2 |
m |
242 |
303 |
363 |
3 |
m |
200 |
276 |
314 |
4 |
m |
216 |
282 |
330 |
5 |
m |
242 |
303 |
368 |
6 |
w |
227 |
274 |
285 |
7 |
w |
206 |
253 |
273 |
8 |
w |
223 |
245 |
268 |
9 |
w |
196 |
232 |
260 |
10 |
w |
203 |
234 |
262 |
Mean Values:
Sex |
n |
Day 0 |
Day 7 |
Day 14 |
males |
5 |
229 |
291 |
341 |
females |
5 |
211 |
248 |
270 |
m + f |
10 |
220 |
269 |
305 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 value for male and female animals is greather than 10 000 mg/kg bw.
- Executive summary:
The acute oral toxicity of Hydroxyambran was determined according to the OECD Test Guideline 401 in a limit test with 10 000 mg/kg bw in rats.
No animals died during the course of the study.
Abnormal clinical signs were observed only within 1h - 48h p.a.
Weight gains were normal in all animals.
Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.
The LD50 value for male and female animals is greather than 10 000 mg/kg bw.
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