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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-486-9 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-09-12 to 1994-10-20
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Justification for the read-across from the introduced read-across supporting substance (CAS 67938 -21 -0) to the registration substance:
The introduced read-across supporting substance (CAS 67938-21-0) is structurally related to the registration substance. Both substances are fatty acid esters of polyglycerols, the only diffence being that the introduced read-across source substance (CAS 67938-21-0) is synthesized by using isostearic acid as fatty acid while the registration substance by using stearic acid.
Both substances are expected to undergo enzymatic hydrolysis resulting into the release of polyglyerols and the corresponding fatty acids (isostearic acid for the read-across supporting substance and the stearic acid for the registration substance. Isostearic acid as well as the stearic acid are well-investigated substances and occurs also endogenously. No difference in the skin sensitization property can be reliably derived. - Reason / purpose for cross-reference:
- assessment report
- Interpretation of results:
- GHS criteria not met
- Executive summary:
No classification is warranted for the registration substance based on the read-across data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed in 1994. No LLNA was available at that time.
Test material
- Reference substance name:
- Diglyceryl-diisostearate
- IUPAC Name:
- Diglyceryl-diisostearate
- Reference substance name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- EC Number:
- 267-821-6
- EC Name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Cas Number:
- 67938-21-0
- Molecular formula:
- C42H82O7
- IUPAC Name:
- di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Hostacerin DGI; Synonym: Fettsaeurepolyglycerinester
- Physical state: Liquid, light yellow
- Lot/batch No.: E06 213955
- Expiration date of the lot/batch: End of August 1996
- Storage condition of test material: in the dark at room temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol : Water (80 : 20)
- Concentration / amount:
- Pretest:
100 % undiluted test substance, 20 % (w/v) test substance diluted in Ethanol : Water (80 : 20); 4,0 % (w/v) test substance diluted in Ethanol : Water (80 : 20)
Induction:
100% undiluted test substance
Challenge:
20 % (w/v) test substance diluted in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol : Water (80 : 20)
- Concentration / amount:
- Pretest:
100 % undiluted test substance, 20 % (w/v) test substance diluted in Ethanol : Water (80 : 20); 4,0 % (w/v) test substance diluted in Ethanol : Water (80 : 20)
Induction:
100% undiluted test substance
Challenge:
20 % (w/v) test substance diluted in acetone
- No. of animals per dose:
- Pretest: 2 animals/dose concentration (i. e. 6 animals total)
Control group: 10 animals
Treatment group: 20 animals - Challenge controls:
- The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 % undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 % undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.
- Executive summary:
In order to test for possible skin sensitizing effects, the test substance was investigated in a guinea pig skin sensitization test according to Buehler. 20 Pirbright-White guinea pigs in the treatment group and 10 animals in the control group were used. Dermal induction was performed using 100 % test item. The control group was exposed to an ethanol : water (80 : 20) mixture only. Challenge treatment was carried out with 20 % test substance in acetone. Under the test conditions of the present study, none of the 20 animals of the treatment group showed a positive skin response after the challenge procedure (sensitization incidence = %).
Based on the results of this study the test substance registered showed no evidence for sensitizing properties and thus is not subject for labeling requirements with regard to skin sensitization.
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.