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EC number: 225-878-4 | CAS number: 5131-66-8
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/1987-10/1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD guideline 414.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- only 2 dose levels
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-butoxypropan-2-ol
- EC Number:
- 225-878-4
- EC Name:
- 1-butoxypropan-2-ol
- Cas Number:
- 5131-66-8
- Molecular formula:
- C7H16O2
- IUPAC Name:
- 1-butoxypropan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): propylene glycol n-butyl ether (PnB)
- Physical state: clear, colourless liquid
- Analytical purity: >98%
- Lot/batch No.: XZ 95410.00
- Stability under test conditions: stable up to 200°C
- Storage condition of test material: at ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann Versuchstierzucht GmbH & Co. KG, Borchen, Germany
- Age at study initiation: 13 weeks (females) & 14 weeks (males)
- Weight at study initiation: 182 to 218 g (females)
- Fasting period before study: none
- Housing: five females per cage and males individually housed in suspended steel cages fitted with wire-mesh floors and fronts
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ca. one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): at least 40%
- Air changes (per hr): 8-10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- propylene glycol
- Details on exposure:
- TEST SITE
- Area of exposure: shaved back skin
- coverage: 20cm2
- Type of wrap if used: no wrap (uncovered)
- Time intervals for shavings or clipplings: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): prior to daily application the treated skin was cleaned with lukewarm water moistened sponge
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.5 ml/kg body weight
- Concentration (if solution): ratios of 40:60 and 12:60 PnB in propylene glycol
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): based on preliminary dermal irritation study and the pilot dermal embryotoxicity study it was decided to apply the test substance in a solution with propylene glycol
- Amount(s) applied (volume or weight with unit): 1.5 ml/kg body weight
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes (neck collars) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were taken from each test solution and stored at 4°C until analysis. Samples were diluted with acetone and analyzed by gas chromatography using a flame ionization detector.
For gas chromatographic conditions see attachment provided below. - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: overnight untill detection of sperm cells in the female (max. 4 days)
- Males found to have mated were assigned to each group in rotation
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 6 to 16 of pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- untill day 21 of pregnancy
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on results of a preliminary dermal toxicity study showing that PnB was well-tolerated by pregnant female rats applied dermally at levels up to 1.0 ml/kg bw/day
- Rationale for animal assignment: random
Examinations
- Maternal examinations:
-
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: general condition and behaviour of the animals was checked daily and local skin reactions, if any, were recorded
BODY WEIGHT: Yes
- Time schedule for examinations: animals were individually weighed on day 0, day 6, day 16 and day 21 of pregnancy
FOOD CONSUMPTION : Yes
-quatitiy of food consumed by each animal of each group was determined during the following periods: day 0 to day 6 and day 6 to day 16 and day 16 to day 21.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: both ovaries, uterus, kidneys and the liver - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter]
- Head examinations: No data - Statistics:
- For the statistical analyses of differences in degree of ossification between the test and control groups Student's t-test was applied to transformed ossification values expressed in degrees.
Statistical analysis of differences in body weight, food consumption, organ weights, litter data, foetus weights and lengths and placenta weights was carried out by applying analysis of (co)-variance, with body weights on day 0 as the covariable, followed by Dunnet's multiple comparison test, wherea skeletal and visceral anomalies were evaluated by the Chi-square test. - Indices:
- Percentage of pre-implantation loss (PRIL) was calculated for each litter according to the formula below.
PRIL=100%*(number of corpora lutea-number of implantation sites/number of corpora lutea)
Percentage of post-implantation loss (POIL) was calculated for each litter according to the formula below.
POIL=100%*(number of implantation sites-number of live pubs/number of implantation sites)
Degree of ossification (DgO) of foetus skeletons was calculated for each litter according to the formula below.
DgO=number of bones without ossification (or with incomplete ossification)/number of bones examined
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Minor skin reaction were observed. However, these were not considered of importance to the study. There were no statistical differences in body weight and food intake, in the weight of ovaries, uterus, kidneys and liver between control- and test groups.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 880 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 880 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No compound related visceral and skeletal malformations, anomalies or variants were observed at any dose level.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 880 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity overlal effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Propylene glycol n-butyl ether did not induce developmental effects up to 1.0 ml/kg bw/day (highest dose level tested).
- Executive summary:
Three groups of 25 mated Wistar rats received dermal applications of 0, 0.3 and 1.0 ml/kg bw/day propylene glycol n-butyl ether (DOWANOL PnB) from day 6 -16 of pregnancy. The control group was treated with 1.5 ml propylene glycol/kg bw/day. The PnB in the test groups was provided as two mixtures in propylene glycol at the ratios 12:60 and 40:60. Because of the non-occluded applications, collars were used to prevent oral uptake. The study was conducted according to OECD guideline 414.
No mortality, and no abnormalities in condition and behaviour occurred. Minor skin reactions were observed in the PnB. These were not considered of importance for the study. There were no statistical differences in body weight and food intake, in the weight of ovaries, uterus, kidneys and liver between control- and test groups.
Maternal performance was comparable in all groups. no compound related visceral and skeletal malformations, anomalies or variants were observed, that could be related to the treatment with PnB.
The limit concentration of 1.0 ml/kg bw/day produced minor local skin reactions, but no further toxicity in the dams. Daily dermal applications of 0.3 or 1.0 ml/kg bw/day from day 6 through 16 of pregnancy did not induce embryo/foeto toxicity nor teratogenic effects.
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