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EC number: 500-038-2 | CAS number: 25322-68-3 1 - 4.5 moles ethoxylated
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- EC Number:
- 500-038-2
- EC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Cas Number:
- 25322-68-3
- Molecular formula:
- (C2-H4-O)mult-H2-O
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Molecular formula :(C2-H4-O)mult-H2-O
- Molecular weight :44.0526 g/mol
- Substance type: organic
- Appearance: Colourless clear liquid
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Bharat Serum and Vaccines Limited, India.
- Age at study initiation:8- 10 weeks at the time of dosing.
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 134 g Maximum: 165 g (Individual body weights were within ± 7% prior to treatment after overnight fasting)
- Fasting period:The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing.
- Housing:The animals were housed individually in polycarbonate cages..
- Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. Animal nos. 1-3 were acclimatized for 5 days, 4-6 for 9 days, 7-9 for 14 days and 10-12 for 5 days, prior to administration of the test item
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C Maximum: 23.20 °C
- Humidity (%):Minimum: Minimum: 48.60% Maximum: 69.20%.
- Air changes (per hr):More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12:12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):N/A
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight. - Doses:
- G1 = 300 mg/kg bw
G2 = 2000 mg/kg bw - No. of animals per sex per dose:
- 12 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2 for external and internal observations.
- Other examinations performed:
Clinical Observation:
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the surviving animals were observed once a day during the 14 day observation period.
Body weight:
All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
other:
Mortality:
All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- No mortality was observed througout the experimentation period
- Clinical signs:
- other: At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.
- Gross pathology:
- No external and internal gross pathological examination were seen in all the animals treated with 300 and 2000 mg/kg body weight during terminal sacrifice .
- Other findings:
- not specified
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 300 |
138 |
168 |
187 |
21.74 |
35.51 |
2 |
139 |
175 |
186 |
25.90 |
33.81 |
|
3 |
144 |
183 |
203 |
27.08 |
40.97 |
|
4 |
145 |
176 |
191 |
21.38 |
31.72 |
|
5 |
152 |
185 |
205 |
21.71 |
34.87 |
|
6 |
149 |
180 |
190 |
20.81 |
27.52 |
|
7 |
G2/ 2000 |
160 |
185 |
199 |
15.63 |
24.38 |
8 |
165 |
189 |
203 |
14.55 |
23.03 |
|
9 |
156 |
192 |
200 |
23.08 |
28.21 |
|
10 |
134 |
174 |
192 |
29.85 |
43.28 |
|
11 |
138 |
169 |
179 |
22.46 |
29.71 |
|
12 |
141 |
178 |
195 |
26.24 |
38.30 |
Key:- = Not Applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 300 |
Mean |
144.50 |
177.83 |
193.67 |
23.10 |
34.07 |
SD |
5.47 |
6.18 |
8.24 |
2.67 |
4.45 |
|
n |
6 |
6 |
6 |
6 |
6 |
|
G2/ 2000 |
Mean |
149.00 |
181.17 |
194.67 |
21.97 |
31.15 |
SD |
12.93 |
8.98 |
8.59 |
5.95 |
8.01 |
|
n |
6 |
6 |
6 |
6 |
6 |
Keys:- = Not Applicable, SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 300 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
|
7 |
G2/ 2000 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
|
11 |
1 |
1 |
1 |
1 |
1 |
|
12 |
1 |
1 |
1 |
1 |
1 |
Keys:- = Not applicable,
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
G1/ 300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
7 |
G2/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
11 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
12 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The lethal concentration LD50 value for acute oral toxicity test was considered to be >2000 mg/kg bw,when female wistar rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
- Executive summary:
Acute Oral Toxicity Study of test chemical in female wistar Rats.This study was performed as per OECD Guideline No. 423. Twelve female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 300 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 300 mg/kg weight and no mortality was observed.Hence, three rats of group G2 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed.Hence, further dosing was stopped.Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 300 and 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 300 and 2000 mg/kg, all the animals were observed with normal clinical sign till day 14.No external and internal gross pathological examination were seen in all the animals treated with 300 and 2000 mg/kg body weight during terminal sacrifice.The acute oral LD50 value of test chemical was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Unclassified” criteria of CLP.
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