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EC number: 242-894-7 | CAS number: 19224-26-1
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to approved guidelines and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Copy of certificate of compliance from UK GLP Monitoring Authority included in report
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Propane-1,2-diyl dibenzoate
- EC Number:
- 242-894-7
- EC Name:
- Propane-1,2-diyl dibenzoate
- Cas Number:
- 19224-26-1
- Molecular formula:
- C17H16O4
- IUPAC Name:
- 1-(benzoyloxy)propan-2-yl benzoate
- Reference substance name:
- 1,2-propan-diyl-dibenzoate
- IUPAC Name:
- 1,2-propan-diyl-dibenzoate
- Reference substance name:
- K-FLEX* PG
- IUPAC Name:
- K-FLEX* PG
- Test material form:
- other: clear light yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): Kalama® K-FLEX® PG
- Substance type: Plasticizer
- Physical state: Colourless to pale yellow liquid
- Analytical purity: 97.1% propylene glycol esters
- Lot/batch No.: KAKPG43301
- Expiration date of the lot/batch: 05 March 2016
- Storage condition of test material: Ambient temperature
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 17.2 to 21.5 g
- Housing: 2 per cage
- Diet: ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 deg C
- Humidity (%): 40-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: 24 April 2014 To: 2 June 2014
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- as supplied and then 50% and 25% of "as supplied" solution
- No. of animals per dose:
- 2 - preliminary study
4 - main study - Details on study design:
- The results of the preliminary investigations indicated that ‘as supplied’ was a suitable high concentration for administration in the main phase of the study. The low and intermediate concentrations were selected from the concentration series given in regulatory guidelines and
the concentrations administered on the main study were:
25, 50% v/v in AOO and ‘as supplied’
The positive control group received 25% v/v hexylcinnamic aldehyde in AOO based on previous experience at this laboratory.
Main phase
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 µL of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using an automatic micropipette and was spread over the entire dorsal surface of the ear using the tip of the pipette. Further groups of four mice received the vehicle alone or the positive control substance in the same manner and a sham control group was treated by the tip of an empty pipette being passed over the surface of the ear.
Administration of 3H-methyl Thymidine
In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl Thymidine (3HTdR: 80 µCi/mL) giving a nominal 20 µCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None stated
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 25 % v/v PDGB
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 50% v/v PGDB
- Key result
- Parameter:
- SI
- Value:
- 5.2
- Test group / Remarks:
- as supplied’ PGDB
- Key result
- Parameter:
- SI
- Value:
- 10.6
- Test group / Remarks:
- Positive Control - hexyl cinnamic aldehyde (HCA)
- Key result
- Parameter:
- EC3
- Value:
- 52.2
- Test group / Remarks:
- PGDB
- Key result
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI (test/control ratios) obtained for 25, 50% v/v and ‘as supplied’ PGDB were 0.9, 1.6 and 6.3 respectively. As a SI of 3 or more was recorded for the highest concentration tested (as supplied), PGDB was considered to have the potential to cause skin sensitization. Based on the results of this study the EC3 value is calculated to be 52.2% v/v. The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 10.6 which demonstrates the validity of this study.
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Group 3 sham control: 6808.35 dpm and 851.04 dpm/node Group 4 vehicle: 5119-65 dpm and 639.96 dpm/node Group 5 25% v/v: 9756.55 dpm and 1219.57 dpm/node Group 6 50% v/v: 19744.35 dpm and 2468.04 dpm/node Group 7 as supplied 26483.75 dpm and 3310.47 dpm/node Group 8 HCA 25% v/v 71843.55 dpm and 8980.44 dpm/node
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on an LLNA study, PGDB is regarded as a potential skin sensitizer. The EC3 value was calculated to be 52.2% v/v.
- Executive summary:
The SI (test/control ratios) obtained for 25, 50% v/v and ‘as supplied’ PGDB were 1.4, 2.9 and 5.2 respectively. As a SI of 3 or more was recorded for the highest concentration tested (as supplied), PGDB was considered to have the potential to cause skin sensitization. Based on the results of this study the EC3 value is calculated to be 52.2% v/v. The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 10.6 which demonstrates the validity of this study.
PGDB is regarded as a potential skin sensitizer.
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