Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-991-7 | CAS number: 7397-62-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-Jan-05 through 1989-Feb-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Butyl glycollate
- EC Number:
- 230-991-7
- EC Name:
- Butyl glycollate
- Cas Number:
- 7397-62-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- butyl glycolate
- Reference substance name:
- Polysolvan O
- IUPAC Name:
- Polysolvan O
- Reference substance name:
- Glycolic acid-n-butyl ester
- IUPAC Name:
- Glycolic acid-n-butyl ester
- Details on test material:
- - Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: about 97.3%
- Impurities (identity and concentrations): 0.1% unknown, <0.1% n-butanol, <0.1% di-n-butyl ether, 0.2% chloro acetic acid-n-butyl ester, 2.1% butoxy acetic acid n-butyl ester; <0.1% di-glycolic acid di-n-butylester, 0.3% water, 0.005% glycolic acid
- Purity test date: 09-Aug-1988
- Lot/batch No.: Laufprobe 09-Aug-1988
- Stability under test conditions: stable
- Storage condition of test material: in the dark, 20 °C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst Kastengrund, Germany
- Age at study initiation: about 6 weeks
- Fasting period before study: none
- Housing: 5/cage
- Diet (e.g. ad libitum): ad libitum, standard chow (Altromin 1324, Lage, Germany)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 1989-01-05 To: 1989-02-02
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
daily
VEHICLE
- Justification for use and choice of vehicle (if other than water): low solubility in water, high solubility in sesame oil
- Concentration in vehicle: 0, 0.16, 0.8, 4.0, 20.0%
- Amount of vehicle (if gavage): 5 ml/g bw - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 29 days, 28 applications
- Frequency of treatment:
- daily, prior to application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 8, 40, 200, 1000 mg/kg bw/day (m/f)
Basis:
other: nominal in sesame oil
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: at start of study and twice/week
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, twice/week
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: once/week
OPHTHALMOSCOPIC EXAMINATION: Not required according to guideline
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of treatment
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: 5 m/5 f
- Parameters examined: erythrocytes, hemoglobin, hematocrit, MCV, MCH, MCHC, white blood cells, thrombocytes, differential blood picture, reticulocytes, Heinz bodies (control and high dose group), coagulation time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of treatment
- Animals fasted: No
- How many animals: 5 m/5 f
- Parameters examined: sodium, potassium, calcium, chloride, inorganic phosphor, total billirubin, billirubin direct, glucose, uric acid, creatinine, urea, protein, ASAT, ALAT, y-GT, alkaline phosphatase, albumin, alpha1-3 globulin, beta1 globulin, y1 globulin, albumin/globulin ration
URINALYSIS: Yes
- Time schedule for collection of urine: at the end of treatment
- Metabolism cages used for collection of urine: No
- Animals fasted: No
- Parameters examined: appearance, color, pH, hemoglobin, protein, glucose, ketones, billirubin, urobilirubin, specific weight
NEUROBEHAVIOURAL EXAMINATION: No: not required - Sacrifice and pathology:
- GROSS PATHOLOGY: complete necropsy
ORGAN WEIGHTS: heart, lung, liver, kidney, spleen, testes, adrenal glands
HISTOPATHOLOGY: heart, lung, liver, kidney, spleen, thymus, testes, stomach, small intestine (jejunum), large intestine (colon), bone marrow (femur), adrenal glands - Statistics:
- Mean and standard deviation was calculated
Methods: Dunnett, Sidak, followed by Nemenyi
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL CHEMISTRY
at 1000 mg/kg bw(day: slight increase in inorganic phosphor and slight decrease in protein in both sexes
URINALYSIS
at 1000 mg/kg bw/day: slight increase of erythrocytes in sediment in both sexes
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- 200 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
- Dose descriptor:
- NOAEL
- Remarks:
- 1000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Slight increase in inorganic phosphor, slight decrease in protein, slight increase of erythrocytes in urine sediment in both sexes. All observed findings are known to be reversible.
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Body weight (mean)
mg/kg bw/day |
0 |
8 |
40 |
200 |
1000 |
Males |
|
|
|
|
|
Day 1 (g) |
132 |
128 |
121 |
125 |
130 |
Day 29 (g) |
273 |
277 |
260 |
274 |
254 |
Females |
|
|
|
|
|
Day 1 (g) |
119 |
121 |
125 |
120 |
123 |
Day 29 (g) |
175 |
180 |
188 |
185 |
183 |
Food consumption (mean)
mg/kg bw/day |
0 |
8 |
40 |
200 |
1000 |
Males |
|
|
|
|
|
Day 1 (g/day) |
17.8 |
17.0 |
16.4 |
16.6 |
17.6 |
Day 29 (g/day) |
16.4 |
15.9 |
15.2 |
15.5 |
14.7 |
Day 1-29 (g/day) |
17.3 |
17.7 |
16.9 |
17.4 |
16.3 |
Females |
|
|
|
|
|
Day 1 (g/day) |
15.5 |
15.8 |
16.7 |
16.1 |
15.8 |
Day 29 (g/day) |
10.9 |
10.0 |
11.4 |
10.4 |
9.2 |
Day 1-29 (g/day) |
12.5 |
12.3 |
13.5 |
13.0 |
12.5 |
Clinical chemistry (changed parameter, mean)
mg/kg bw/day |
0 |
8 |
40 |
200 |
1000 |
Males |
|
|
|
|
|
Inorganic phosphor (mmol/L) |
2.34 |
2.38 |
2.57 |
2.63 |
3.18 |
Protein (g/L) |
59 |
61 |
56 |
56 |
54 |
Females |
|
|
|
|
|
Inorganic phosphor (mmol/L) |
2.62 |
2.18 |
2.64 |
2.65 |
3.7 |
Protein (g/L) |
59 |
60 |
55 |
54 |
51 |
Applicant's summary and conclusion
- Conclusions:
- The no observed effects level (NOEL) for subacute oral (gavage) toxicity in male and female Wistar rats was 200 mg/kg bw/day under the conditions of the study. The top dose level of 1000 mg/kg bw/day can be considered as no observed adverse effect level (NOAEL) as only minor changes were noted, generally accepted to be reversible.
- Executive summary:
The subacute oral toxicity of Polysolvan O (butyl glycollate, 97.3%) was investigated in male and female Wistar rats. Each 5 males and 5 females received dose levels of 0, 8, 40, 200 and 1000 mg/kg bw/day by daily gavage during a period of 29 days (28 applications).The test item was dissolved in sesame oil. Mortality, clinical findings and behavior were examined at least once a day, body weight and food consumption was determined twice a week and water consumption once a week. At the end of the application, hematology, clinical chemistry and urinalysis were performed. After sacrifice, a complete necropsy was performed, organ weights were determined and the animals were subjected to histopathology.
This study is assessed as appropriate and valid since it was performed according to an internationally accepted testing guideline and according to GLP. Reporting, assessment and data presentation in the study report was considered as appropriate.
No animal died prior to schedule and there were no clinical signs of toxicity. No effect was noted for body weight/body weight gain, food/water consumption and hematology. Gross pathology and histopathology revealed no treatment related findings and the organ weights were not affected.
Only at the top dose level of 1000 mg/kg bw/day there was a slight increase in inorganic phosphor and slight decrease in protein as well as a slight increase of erythrocytes in urine sediment in both sexes. However, all findings are known to be reversible.
The study is considered as acceptable as it was performed according to the OECD guideline 407 (adopted 1981) under GLP conditions.
Conclusion:
Polysolvan O (butyl glycollate, 97.3%) was tolerated up to the limit dose level of 1000 mg/kg bw/day without any adverse finding of systemic toxicity. Only isolated minor and reversible changes in clinical chemistry and urinalysis were noted. The NOEL for subacute toxicity was 200 mg/kg bw/day, while the NOAEL can be considered as 1000 mg/kg bw/day for male and female Wistar rats.
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.