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Diss Factsheets
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EC number: 701-435-5 | 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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Liponate 2-DH CIR Report April 7, 2015
- Author:
- Cosmetic Ingredient Review
- Year:
- 2 015
- Bibliographic source:
- CIR Report April 7, 2015
Safety Assessment of PEG Diesters as Used in Cosmetics
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Remarks:
- It's taken from the publication and the GLP compliance is not specified.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study performed in 1985 before the LLNA method
Test material
- Reference substance name:
- PEG-4 Diheptanoate
- Molecular formula:
- UVCB
- IUPAC Name:
- PEG-4 Diheptanoate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: BC/DHA
- Sex:
- male
- Details on test animals and environmental conditions:
- 10 male
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: dimethyl phthalate
- Concentration / amount:
- 0.05 mL and 0.1 mL
- Day(s)/duration:
- 5 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: dimethyl phthalate
- Concentration / amount:
- 0.05 mL
- Day(s)/duration:
- 5 weeks
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 guinea pigs at 0.05 mL and 0.1 mL
- Details on study design:
- The test substance was administered to the shaved skin of the shoulder of the guinea pigs followed 2 days later by an injection of dimethyl phthalate (1%; 0.1 mL).
Three more injections, 1 week apart, were administered to complete the induction phase. After a 13-day rest period, the challenge was administered as a topical administration of PEG-4 diheptanoate (5% or 50% in dimethyl phthalate; 0.05 mL) to the same shaven shoulder. The control consisted of a group of naïve guinea pigs (n=10) that were administered the challenge. Test sites were evaluated for reactions at 24 and 48 h after administration of the challenge. - Challenge controls:
- yes
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a dermal sensitization study using male BC/DHA guinea pigs (n=10), PEG-4 diheptanoate (5% or 25%; 0.05 mL in dimethyl phthalate) was not sensitizing when challenged at 5% or 50%.
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