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EC number: 946-420-6 | 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-10-06 to 1992-10-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- EC Number:
- 946-420-6
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin served as negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min after removal of the semi-occlusive dressing and 24, 48 and 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: Ypsiplast ® (Holthaus Medical), held by non-irritating tape Elastoplast ® (Beiersdorf AG, Hamburg) and Stülpa ® (P. Hartmann AG, Heidenheim-Brenz)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual sample was carefully washed off with water or an appropriate solvent
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Day of exposure at 30-60 min after patch removal and 24, 48 and 72 h after patch removal
SCORING SYSTEM: according to OECD Test Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in 2/3 animals up to 48 h after patch removal, which were fully reversible within 72 h.
- Other effects:
- No other effects observed
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema Max. score: 4 |
Edema Max. score: 4 |
30 – 60 min |
1/0/1 |
0/0/0 |
24 h |
1/0/1 |
0/0/0 |
48 h |
1/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.67/0/0.67 |
0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Polyglycerin caprinate was not irritating in thin in vivo skin irritation study in rabbit.
- Executive summary:
In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area. Animals then were observed for 72 h. Irritation was scored by the method of OECD Test Guideline 404.
During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.
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