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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.03.2006 to 29.05.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD & EEC guideline study no deviations 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Rabbit, New Zealand White / specific Pathogen Free (SPF) strain were supplied by Charles River Laboratories Site ESD-Romans-01400 Châtillon sur Chalaronne, France.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 ml of test item / eye
- Concentration (if solution):undiluted
- Duration of treatment / exposure:
- test item absorbed / not removed after dosage
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days after dosing
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- Undiluted test item was introduced into the right eye of each animal by gently pulling away the lower lid from the eyeball to form a cup into which the test item was placed. The lids were then held shut for a few seconds to prevent loss of the test item. No rinse of the eye was performed. The left eye remained untreated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- , conjunctival redness
- Basis:
- animal #1
- Remarks:
- no.343
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- conjunctivae score
- Remarks:
- , conjunctival redness
- Basis:
- animal #2
- Remarks:
- no.345
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- conjunctivae score
- Remarks:
- , conjunctival redness
- Basis:
- animal #3
- Remarks:
- no.347
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- chemosis score
- Remarks:
- , conjunctival chemosis
- Basis:
- animal #1
- Remarks:
- no.343
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- chemosis score
- Remarks:
- , conjunctival chemosis
- Basis:
- animal #2
- Remarks:
- no.345
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- chemosis score
- Remarks:
- , conjunctival chemosis
- Basis:
- animal #3
- Remarks:
- no.347
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- cornea opacity score
- Remarks:
- , corneal opacity
- Basis:
- animal #1
- Remarks:
- no.343
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- , corneal opacity
- Basis:
- animal #2
- Remarks:
- no.345
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- , corneal opacity
- Basis:
- animal #3
- Remarks:
- no.347
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- , iris inflammation
- Basis:
- animal #1
- Remarks:
- no.343
- Time point:
- other: 24, 48 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- iris score
- Remarks:
- , iris inflammation
- Basis:
- animal #2
- Remarks:
- no.345
- Time point:
- other: 24, 48 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritation parameter:
- iris score
- Remarks:
- , iris inflammation
- Basis:
- animal #3
- Remarks:
- no.347
- Time point:
- other: 24, 48 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: mean, observed values
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- None:
There was no indication of a systemic effect of treatment.
The body weights of animals were considered to be within the normal range of variability.
Any other information on results incl. tables
None: There was no indication of a systemic effect of treatment. The body weights of animals were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: the substance is not irritating according to Directive 67/548/EEC but it is classified as Eye irritant Category 2 according to CLP Regulation.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isobornyl ether (mixture of isomers) is not irritating to eyes.
According to the CLP Regulation, the substance is classified as Eye irritant, Category 2, based on the scores obtained for the corneal opacity, which are above 1 for the three animals. - Executive summary:
The acute eye irritation of Dipropylenglykolisobornylether (isomerengemisch) was investigated in rabbits in accordance with OECD Guideline 405 (Acute Eye Irritation / Corrosion) and EU Guidelines B.5.
A 0.1 ml aliquot of the test item (undiluted) was introduced in to the right eye of a total of 3 animals.
The resulting reaction to treatment was assessed 1, 24, 48,and 72 hours and 7 days after treatment.
Slight conjunctival redness, chemosis an ocular discharges were observed in the three animals at 1 hour examination.
Moderate concjuntival redness and ocular discharges, well defined chemosis, slight to moderate iris inflammation and moderate corneal opacity were then observed in the three animals at 24 hours examination.
Slight to absent ocular discharge, slihgt concjuntival redness, well defined to absent chemosis, slight to moderate to absent iris inflammation and slight cornela opacity were observed in 1 animal at the 48 and 72 hours examinations.
Observations of the remaining 2 animals, performed at the same examination time, revealed slight concjuntival redness and slight to absent chemosis.
Slight to well defined corneal opacity was observed in these two animals at 48 hours examination while slight corneal opacity was observed in the same animals at 72 hours examination.
Complete recovery has ocurred 7 days after dosing. There was no indication of systemic effect of treatment. The body weights of animals were considered to be within the normal range of variability.
These results indicate that based upon classification criteria of European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) Dipropylen glycol isobornyl ether (mixture of isomers) is not irritating to eyes.
According to the CLP Regulation, the substance is classified as Eye irritant, Category 2, based on the scores obtained for the corneal opacity (calculated as the mean scores following grading at 24, 48 and 72 h) which are above 1 for the three animals and which fully reverses within the observation period.
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