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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 918-906-8 | CAS number: 65684-27-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 27 Nov - 21 Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The DPRA assay resulted in a positive outcome whereas the h-CLAT assay gave a negative result. Taking into account the discrepancy in the results of the in vitro tests and the fact that the chemistry of the registration substance is complex an in vivo test was conducted. The GMPT was preferred over the LLNA due to the likelihood of the latter mentioned test producing false positive results with this type of substance - glyceryl undecylenate.
Test material
- Details on test material:
- - Name of test material: undecylenate de glycerol
- Physical state: Pale yellow gel
- Analytical purity: 100%
- Lot/batch No.: 18060502
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France
- Weight at study initiation: 338.2 - 391.5 g
- Housing: in cages of standard with saw dust bedding
- Diet: FD1 (P) SQC, SDS/DIETEX and V2233-000, SSNIFF feed, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Induction:
Intradermal: 1 %
Epicutaneous: 100%
Challenge: 50%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction:
Intradermal: 1 %
Epicutaneous: 100%
Challenge: 50%
- No. of animals per dose:
- Control groups: 5 males
Treated group: 10 males - Details on study design:
- RANGE FINDING TESTS:
In the preliminary study, the concentrations of 0.5%, 1%, 5%, 10%, 25% and 50% were tested for the intradermal injection and the concentrations of 25%, 50% 75% and 100% were tested for the topical application.24 hours after intradermal injection of Glyceryl undecylenate, skin lesions were graded as score 2 (moderate and confluent erythema) at the concentrations of 0.5% and 1% and as score 3 (intense erythema and swelling) at the concentrations of 5% to 50%. One hour after the removal of the occlusive dressing of a topical application of Glyceryl undecylenate for 48 hours, skin lesions were graded as score 1 (discrete or patchy erythema) at the concentrations of 75% and 100%. 24 hours after the removal of the occlusive of a topical application of Glyceryl undecylenate for 24 hours, no visible skin changes were observed at the concentrations of 25% and 50% and skin lesions were graded as score 1 (discrete or patchy erythema) at the concentrations of 75% and 100%. 48 hours after the removal of dressing, no visible skin changes were observed, whatever the concentration tested.
According these results, the concentrations of Glyceryl undecylenate chosen for the main study were:
• 1% for the primary induction (intradermal injection on D1)
• 100% for the second induction (topical application on D9)
• 50% for the challenge (topical application on D22)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: FCA and sterile and pyrogen-free isotonic sodium chloride solution
Injection 2: test substance in corn oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in corn oil in a 1:1 mixture (w/v) FCA and sterile and pyrogen-free isotonic sodium chloride solution
- Control group:
Injection 1: FCA and sterile and pyrogen-free isotonic sodium chloride solution
Injection 2: corn oil
Injection 3: corn oil in a 1:1 mixture (w/v) FCA and sterile and pyrogen-free isotonic sodium chloride solution
Epicutaneous: vaseline
- Site: shoulder region (intradermal + epicutanous)
- Frequency of applications: every 9 days
- Duration: Days 0-9
- Concentrations: intradermal 1%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: cranial (vehicle) and caudal (test substance)
- Concentrations: 50%
- Evaluation (hr after challenge): 48 and 72 - Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs were noted
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 1%; challenge: 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs were noted
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- In animals treated with Glyceryl undecylenate, 2/10 animals showed a slight erythema (score 1) and 7/10 animals showed a moderate erythema (score 2) on D24 (i.e. 24 hours after removal of occlusive dressing).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs were noted
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 1%; challenge: 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs were noted
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- On D25 (i.e. 48 hours after removal of occlusive dressing), 4/10 animals showed a slight erythema (score 1).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no indication
- No. with + reactions:
- 5
- Total no. in group:
- 8
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no indication
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
There was no mortality during the course of the study.
There were no abnormal clinical signs in animals treated with the test item, the negative control substance or the positive control substance, during the study. There was no change in body weight gain between predose and D25, whatever the group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- CLP: skin sensitiser - Sub-category 1A.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Napriek tomu, že agentúra ECHA poskytuje online veľa materiálov vo vašom jazyku, časť tejto stránky je k dispozícii len v anglickom jazyku. Viac informácií o praxi v oblasti viacjazyčnosti v agentúre ECHA.
Internetová stránka agentúry ECHA Stránka nie je plne podporovaná v prehliadači Internet Explorer 7 (a starších verziách). Aktualizujte si prehliadač Internet Explorer na novšiu verziu.
Táto webová lokalita využíva súbory cookies, aby sme vám zabezpečili najlepšie používateľske prostredie na našich webových stránkach.
Viac informácií ako využívame súbory cookies.