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EC number: 938-754-6 | 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:
- 01-08-1989 to 03-09-1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
- Molecular formula:
- Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
- IUPAC Name:
- Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Substrain: Bor: DHPW (SPF), white
- Age at study initiation: no data
- Weight at study initiation: 271 - 350 g
- Housing: max. 5 animals in one cage, Macrolon plastic cages IV: 20 cm high, 33 cm width, 55 cm length
- Diet: ad libitum; Ssniff-G (Alleindiät für Meerschweinchen), pellets
- Water: ad libitum; Macrolon drinking bottles, 300 mI, Fa. Becker & Co., 4629 Castrop-Rauxel
- Acclimation period: 7 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-85
- Air changes (per hr): no data
- Photoperiod: 12/12 , Fluorescent light, 120 lux
IN-LIFE DATES: From: 01.08 1989 To: 03.09.1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Range finding study:
Dermal treatment: 10%, 25%, 50%, 100% in water
Main study:
Intradermal treatment: 10 % in water and 10% in 10 % Freund's Adjuvant complete
Dermal treatment: 50 % in water
Challenge: 10 % in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Range finding study:
Dermal treatment: 10%, 25%, 50%, 100% in water
Main study:
Intradermal treatment: 10 % in water and 10% in 10 % Freund's Adjuvant complete
Dermal treatment: 50 % in water
Challenge: 10 % in water
- No. of animals per dose:
- Range finding:
2 per dose
Main Study:
10/sex - Details on study design:
- RANGE FINDING TESTS:
To exclude primary skin irritations two animals/group were treated dermally in a preliminary study under occlusiv conditions (exposure period 24 h) with the following concentrations (each 0.5 (g) ml/animal) of the sampie: 100 % (undiluted), 50%, 25% and 10% in Aqua deion.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal treatment (on first day)
- Test groups:
1. 0.1 mL FCA in aqua deion.; 2 (by pairs)
2. 0.1 mL test article (10 %) in aqua deion.; 2 (by pairs)
3. 0.1 mL test article (10 %) in FCA 1:2; 2 (by pairs)
- Control group:
1. 0.1 mL FCA (diluted 1 : 2 in water); 2 (by pairs)
2. 0.1 mL aquq deion.; 2 (by pairs)
3. 0.1 mL aqua deion. (diluted 1 : 2 with FCA); 2 (by pairs)
First dermal treatment (after 7 days)
- Volume: 0.5 mL
- Exposure period: 48 h
- Test groups: 20
- Control group: 20
- Site: first injection were located at the craniodorsal area and the following onces were performed underneath
- Frequency of applications: 1
- Concentrations: 50% in aqua deion.
B. CHALLENGE EXPOSURE (after 22 days)
- No. of exposures: 1
- Day(s) of challenge: 3 weeks after the first intradermal treatment
- Exposure period: 24 h
- Control group: aqua deion.
- Concentrations: 10% in Aqua deion.
- Evaluation (hr after challenge): 24 h, 48 h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC)
- Conclusions:
- In the study performed according to the method of B. Magnusson and A. M Kligman (OECDguidelines) the test substance GRILLOTEN LSE 65 K BATCH 801 is considered to cause no contact hypersensitivity. According to CLP, EU GHS (Regulation (EC) No 1272/2008) and to DSD (Directive 67/548/EEC), no classification and labelling is required.
- Executive summary:
In a dermal sensitisation study performed according to the OECD Guideline 406 (Skin Sensitisation) with Sucroglyceride C12-18, C18unsatd. in water, young adult Pirbright white Guinea Pigs 10/sex were tested using the method of B. Magnusson and A. M Kligman. No positive control data are reported.
No skin reactions were observed in the range finding study or in the main study.
In this study, Sucroglyceride C12-18, C18unsatd. is not a dermal sensitiser.
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