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EC number: 246-770-3 | CAS number: 25265-71-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Available study pre-dates availability of OECD 429 (LLNA) test guideline.
Test material
- Reference substance name:
- Oxydipropanol
- EC Number:
- 246-770-3
- EC Name:
- Oxydipropanol
- Cas Number:
- 25265-71-8
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 1,1-Oxydi-2-Propanol
- Details on test material:
- - Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear viscous liquid
- Analytical purity: 100%
- Lot/batch No.: TB41213-04-2
- Storage condition of test material: in the original container (blue metal can) at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Lab Animals, Wayne, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: males: 386 to 455 g; females: 355 to 422 g
- Housing: housed individually under standard laboratory conditions in the study room.
- Diet (e.g. ad libitum): Camm Guinea Pig Diet or equivalent
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 68-74ºF
- Humidity (%): 35-65%
- Photoperiod (hrs dark / hrs light): 12 hours on/12 hours off cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted 0.5 ml
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted 0.5 ml
- No. of animals per dose:
- Test animals: 10 animals; 7 male, 3 female
Control Animals: 5 animals; 3 male, 2 female - Details on study design:
- RANGE FINDING TESTS:
To determine the correct concentrations to be used for induction (minimal irritation) and challenge (non-irritating), 5 guinea pigs were exposed to 4 concentrations (10, 25, 50 and 100% w/w in distilled water) of the test material in order to determine (approximately) a highest non-irritating concentration and a concentration that caused minimal irritation. In this screen, both sides of the animal were shaved and sites were exposed to the various concentrations of the material; locations of the concentartions were alternated to avoid site-to-site variations; one test site had normal saline applied.
The substance was tested at 0, 10, 25, 50 and 100% w/w concentration in distilled water. There was no irritation and the 100% concentration of the test substance was seleceted for induction and challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
24 hours before first application of the test substance, and subsquently as necessary, hair was closely clipped on the right side of then animals. A dose of 0.5 ml of the freshly prepared test solution was applied to a non-adherent sterile (aproximately 6 cm2) pad coverd by hypo-allerginec cloth tape. The pad was placed on the shaved surface of the animal, and then further occluded with a latex wrap to ensure adequate contract of the test substance with the skin. The patch remained in place for six hours. At the end of the application period, extremely viscous materials were removed by gentle rinse with warm water. This induction procedure was repeated at the same site during the next 2 weeks for a total of three 6-hour exposures. The interval between induction exposures may vary between 5 and 9 days. The animals were then left untreated for approximately 2 weeks prior to primary challenge. If a second challenge was used, animals were rested for at least one week after the primary challenge.
B. CHALLENGE EXPOSURE
2 weeks after the last induction, the animals and a naive group were challanged at a virgin site (left side) with 0.5 ml at the non-irritating concentration at each site. The test substance was applied as for induction. Reactions were scored at approximately 24, 48 and 72 hours after challenge. If there was more than minimal irritation at the virgin site or if animals were considered to have shown a possible positive reaction they were re-challenged 2 weeks later at an unused site. - Challenge controls:
- A group of 5 naive animals were tested for comparison using the challenge concentration - a second naive group was tested for re-challenge if applicable.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic overt effects were observed and no overt reduced gains in body weight were noted.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No systemic overt effects were observed and no overt reduced gains in body weight were noted. .
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- No irritation except for transient slight patchy erythema at one site in 1 of the 5 animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 ml. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: No irritation except for transient slight patchy erythema at one site in 1 of the 5 animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5 ml
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 ml. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- No positive control group.
Applicant's summary and conclusion
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.