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EC number: 470-680-5 | CAS number: 958872-63-4
- 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:
- 10.03.2006 to 01.06.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD & EEC guideline study no deviaions GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 470-680-5
- EC Name:
- -
- Cas Number:
- 958872-63-4
- Molecular formula:
- C16H30O3
- IUPAC Name:
- 1-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-2-ol; 1-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-2-ol; 2-[2-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propoxy]propan-1-ol; 2-{[1-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-2-yl]oxy}propan-1-ol
- Details on test material:
- Name of test material (as cited in study report): Dipropylenglykolisobornylether (isomerengemisch)
- Substance type: mixture of isomers
- Physical state: liquid
- Analytical purity: 97.9% (a/a)
- Impurities (identity and concentrations): as submited substance
- Composition of test material, percentage of components: as submited substance
- Isomers composition: as submited substance
- Lot/batch No.: V04/010-13N
- Expiration date of the lot/batch: 01.03.2008
- Storage condition of test material: ambient temperature
- Other: certificate of analysis Nº AZ-212, Clariant GmbH, Analytical services (23.03.2005)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals were ordered nulliparous and nonpregnant, within the weight range of 250 to 300 grams and 4 to 5 weeks of age. They were
supplied by Harlan Nederland, Kreuzelweg, 53, Horst NL-5960 AD Horst, The Netherlands
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Concentration of test material and vehicle used at induction a) intradermal: 0.1 % in 0.5 % carboxy methyl cellulose; b) topical: undiluted test solution
Concentration of test material and vehicle used for each challenge: Undiluted test solution; 5 concentrations (100, 50, 20, 10 and 5% in 0.5% (w/v)
carboxymethylcellulose) of the test item were each dosed in duplicate.
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Concentration of test material and vehicle used at induction a) intradermal: 0.1 % in 0.5 % carboxy methyl cellulose; b) topical: undiluted test solution
Concentration of test material and vehicle used for each challenge: Undiluted test solution; 5 concentrations (100, 50, 20, 10 and 5% in 0.5% (w/v)
carboxymethylcellulose) of the test item were each dosed in duplicate.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- Patches of gauze measuring 20 mm x 20 mm were coated with 0.2 ml aliquots of the undiluted test item. These were placed on the right flank of each animal, of both test and control groups, in the centre of the prepared skin site. The left flank of each animal was similarly treated with patches soaked with 0.2 ml of the vehicle alone (0.5% (w/v) carboxymethylcellulose).
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction: very slight erythema in all of the test animals.
Evidence of sensitisation of each challenge concentration: In connection with the undiluted test solution, one animal from the test group exhibited a very slight erythema after 24 h which had disappeared again after 48 h. The animals from the control group did not exhibit any skin reactions.
The body weights of the animals were considered to be within the normal range of variability.
Other observations: none
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, one of the nineteen animals (5.3%) of the treatment group showed a very slight skin response after the challenge procedure. Thus, the percentage of animals reacting positive is below the threshold of 30%. Based of the above mentioned findings Dipropylene glycol isobornyl ether (mixture of isomers) does not cause sensitisation by skin contact according to Commission Directive 67/548/EEC and subsequent revisions.
- Executive summary:
The potential of the test item, Dipropylenglykolisobornylether (isomerengemisch), to induce and elicit delayed dermal sensitization was assessed by guinea pig model using the maximization test of Magnusson and Kligman.
The concentration of the test item used in the main study were determined by the resulst of preliminary screening test. The main sensitization test was undertaken using a test group of 20 animals and a control group of 10 animals. In an attempt to induce sensitization, test animals were intradermally injected with an emulsion of Freund's complete adjuvant, the test item at concentration of 0.1 % in the selected vehicle, 0.5% carboxymethylcellulose, and tets item at same concentration in an emulsion of Freund's complete adjuvant.
One week later this was boosted by topical application of the undiluted test item over the injection sites. Control group animals were treated in the same manner but the selected vehicle (0.5% carboxymethylcellulose) wasused in place of the test item. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the undiluted test item.
At the challenge with the undiluted test item, a very slight response wasapparent in 1 of the 19 animals of the test group (5.3%) at 24 hours examination. No reaction was observed at 48 hours examination. No reaction to th test item was observed in any animal from the control group. No reaction to the vehicle alone was observed in any animal.
Based of the above mentioned findings Dipropylene glycol isobornyl ether (mixture of isomers) does not cause sensitisation by skin contact according to Commission Directive 67/548/EEC and subsequent revisions.
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