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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-01-14 to 1993-02-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test according to OECD guideline 402 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:
- 1 993
- Report date:
- 1993
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:
- HYDROXYAMBRAN
- IUPAC Name:
- HYDROXYAMBRAN
- Test material form:
- solid: crystalline
- Details on test material:
- Hydroxyambran
Test Material is a solid, but for the administration the test material was melted at 37 °C and applied as liquid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals:
Species: rat
Strain: Bor: WISW (SPF Cpb)
Source: Firma Winkelmann, Versuchtierzucht, Gartenstr. 27, W-4799 Borchen
Date of receipt December 16, 1992
Acclimation period: at least 5 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: 292 – 327 g; f: 201 – 214 g
Husbandry:
Housing: individual housing in cages (Macrolon type II)
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 22 +/- 3 °C
Relative humidity: 30 – 70 %
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
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- A single dermal application of the test article was performed. The substance was held in contact with the skin with a porous gauze dressing Elastoplast (Beiersdorf). The exposure period was 24 h. The test article was applied undiluted in a volume of 2.11 ml/kg. Prior to administration the test article was warmed in a water bath to 37 °C for 15 min.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Range finding (preliminary study): 2 female animals
Main test: 5 male and 5 female animals - Control animals:
- not required
Results and discussion
- Preliminary study:
- There were no deaths in the preliminary study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD100
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the course of the main study.
- Clinical signs:
- No abnormal clinical signs were observed.
- Body weight:
- Weights gains were normal in all animals
- Gross pathology:
- Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.
- Other findings:
- Skin reactions:
No signs of erythema and oedema were observed apart from very slight or well-defined erythema in one female at day 1 and 2 p.a. Slight scale formation was observed in this animal at day 2 and 5 p.a.
Any other information on results incl. tables
Body weights:
Individual Values:
Animal No. |
Sex |
Day 0 |
Day 7 |
Day 14 |
1 |
m |
301 |
306 |
321 |
2 |
m |
327 |
364 |
389 |
3 |
m |
299 |
307 |
327 |
4 |
m |
321 |
334 |
352 |
5 |
m |
292 |
296 |
314 |
6 |
w |
201 |
201 |
212 |
7 |
w |
214 |
212 |
220 |
8 |
w |
205 |
210 |
211 |
9 |
w |
206 |
198 |
204 |
10 |
w |
203 |
201 |
202 |
Mean Values:
Sex |
n |
Day 0 |
Day 7 |
Day 14 |
males |
5 |
308 |
321 |
341 |
females |
5 |
206 |
204 |
210 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD 50 dermal rats is > 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of Hydroxyambran was determined according to the OECD Test Guideline 402 in a limit test using 2000 mg/kg bw.
The LD 50 dermal rats of Hydroxyambran is > 2000 mg/kg bw.
At this dose died no animal.
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