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EC number: 249-951-5 | CAS number: 29911-28-2
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March-May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 404
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- n/a
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(2-butoxy-1-methylethoxy)propan-2-ol
- EC Number:
- 249-951-5
- EC Name:
- 1-(2-butoxy-1-methylethoxy)propan-2-ol
- Cas Number:
- 29911-28-2
- Molecular formula:
- C10H22O3
- IUPAC Name:
- 1-(2-butoxy-1-methylethoxy)propan-2-ol
- Details on test material:
- Identity: Dowanol-DPnB (n-butoxypropoxypropanol or
dipropylene glycol normal-butyl ether).
CAS # 29911-28-2
Batch No.: XZ 95411.00
Purity: More than 95%.
Appearance: Clear liquid.
Administered as: Undiluted liquid under semi-occlusive
dressing.
Vapor pressure: 0.06 mmHg at 25°C (79 ppm at 1 atm)
Specific Gravity: 0.91 kg/liter.
Solubility: 5% in water.
Storage: At ambient temperature in the dark.
Stability: Stable up to 200°C.
Dipropylene glycol n-butyl ether (DPnB) is a mixture of 4
possible isomers with the major isomers being
1-(1-n-butoxy-2-propoxy)-2-propanol and
2-(1-n-butoxy-2-propoxy)-1-propanol.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, The Netherlands
- Age at study initiation: 9-10 weeks
- Weight at study initiation: n/a
- Housing: individually housed in cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 45-65
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: n/a
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Concentration: 0.5 ml undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- In a primary dermal irritation/corrosivity test, 0.5 milliliters of undiluted dipropylene glycol n-butyl ether (DPnB) was applied to a 6 x 6 cm square gauze patch, which was then applied to an area of clipped, unabraded skin on the left flank of three young adult female New Zealand white rabbits. The test material was held in contact with the skin for a period of 4 hours under a semi-occlusive dressing. After this period, the dressing and test material were removed by washing with tissues and water. The site of application was evaluated for irritation by scoring 1) erythema/eschar and 2) edema. Both criteria were scored on a scale of 0 - 4 at approximately 30 minutes after removal of the test material, and at 24, 48, and 72 hours, and on days 7 and 14. The primary irritation index was calculated by averaging the combined scores for both criteria at 24 and 72 hours for all three animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal #1 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- other: animal #2 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- other: animal #3 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean overall animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- other: animal #1 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: animal#2 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: animal#3 mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean overall animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Undiluted DPnB was found to have a primary irritation index of 2.0 (1.0 for erythema/eschar plus 1.0 for edema) averaged for the three animals at 24, 48 and 72 hours. At 30 minutes and on days 1, 2, and 3, rabbits exhibited slight erythema and edema (scores of 1.0 for each). Edema resolved in all subjects by day 7 and erythema by day 14. All three subjects had slight scaliness over a portion of the treated site over the first 3 days, which disappeared by day 7.
- Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, dipropylene glycol butyl ether was calssified as not irritating to rabbit skin. Mean scores for erythema and edema were 1 for all animals.
- Executive summary:
In a primary dermal irritation/corrosivity test, 0.5 milliliters of undiluted dipropylene glycol n-butyl ether (DPnB) was applied to a 6 x 6 cm square gauze patch, which was then applied to an area of clipped, unabraded skin on
the left flank of three young adult female New Zealand white rabbits. The test material was held in contact with the
skin for a period of 4 hours under a semi-occlusive dressing. After this period, the dressing and test material
were removed by washing with tissues and water. The site of application was evaluated for irritation by scoring 1)
erythema/eschar and 2) edema. Both criteria were scored on a scale of 0 - 4 at approximately 30 minutes after removal
of the test material, and at 24, 48, and 72 hours, and on days 7 and 14. The primary irritation index was calculated
by averaging the combined scores for both criteria at 24 and 72 hours for all three animals.Undiluted DPnB was found to have a primary irritation index of 2.0 (1.0 for erythema/eschar plus 1.0 for edema) averaged
for the three animals at 24 and 72 hours. At 30 minutes and on days 1, 2, and 3, rabbits exhibited slight erythema and
edema (scores of 1.0 for each). Edema resolved in all subjects by day 7 and erythema by day 14. All three
subjects had slight scaliness over a portion of the treated site over the first 3 days, which disappeared by day 7.No systemic toxicity was noted from topical application of DPnB for 4 hours.
This study was identified as key for this toxicity endpoint because of the methods followed (which were comprehensively
documented in the report). The report included GLP and Quality Assurance statements, signed by the Study Director
and Head of the QA Unit, respectively. The study report provided documentation that OECD Protocol 404: "Acute Dermal
Irritation/Corrosion" was followed. Specifically, the numbers and type of test animals used and their husbandry
conditions were as prescribed in the guidance. Test material characterization was adequate. The amount of test
material applied complied with guidance, the length of the observation period (14 days) was sufficient, and scoring
criteria and averaging methods were typical for this type assay and adequately recorded.The authors considered undiluted dipropylene glycol n-butyl ether to be slightly irritating. Classification: According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), the undiluted test substance would not require labeling as a skin irritant.
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