Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 938-458-7 | CAS number: 1443751-77-6
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- November 1992 - March 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant study and generally conducted according to GLP principles
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
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 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- -"OECD Principles of Good Laboratory Practice" (Decision C(81)30 Final), 12 May1981. -"Bonnes Pratiques de Laboratoire" described in the French "Instruction du Ministere des Affaires Sociales et delal Solidarité Nationale" 31 May 1983.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 35627-69-4
- IUPAC Name:
- 35627-69-4
- Test material form:
- other: liquid
- Details on test material:
- amide of fatty acid (C18-branched) and alkanolamine ( 2-hydroxypropylamine): isostearic acid monoisopropanolamide.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No information
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered as supplied.
- Doses:
- preliminary study: 506, 1003 and 2006 mg/kg bw
main study: 2006 mg/kg bw - No. of animals per sex per dose:
- preliminary study: 2.
main study: 5 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed for clinical signs at 15 min, 1, 2 and 4 h after administration and daily thereafter for 14 d. Animals were weighed one day prior to dosing, on the day of dosing, on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic observations of the organs were performed following necropsy on Day 15. - Statistics:
- No information
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 006 mg/kg bw
- Mortality:
- No moratlity observed
- Clinical signs:
- other: No treatment related clinical signs observed
- Gross pathology:
- No treatment related macroscopic necropsy findings observed
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test material was found to be > 2006 mg/kg bw in Sprague Dawley rats
- Executive summary:
A limit test was conducted to determine the acute oral toxicity of the test material in Sprague Dawley rats.
The test material was administered, as supplied, through oral gavage as a single dose of 2006 mg/kg bw to 5 male and 5 female rats. Thereafter the rats were observed for mortality, clinical signs and change in body weight for 14 d. On day 15, the animals were necropsied and the macroscopic observation of the organs were carried out.
All animals survived tiil the end of observation period.There were no treatment related changes in body weights, clinical signs and gross pathology.
Hence, under the test conditions, the acute oral LD50 of the test material was found to be > 2,006 mg/kg bw in Sprague Dawley rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.