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Diss Factsheets
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EC number: 931-291-0 | CAS number: -
- 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
- Study period:
- April 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets the EC Standards (conducted equivalent to OECD 401), although prior to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- lack of reported data; no body weight and no necropsy findings
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Molecular formula:
- For two representative potential structures: C20H36N2O6Na2 : 446 and C18H35N2O4Na: 367
- IUPAC Name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- Sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- other: aqueous solution
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: OLAC 1976, Shaws Farm, Blackthorn, Bicester
- Age at study initiation: young adults
- Weight at study initiation: 160-250 g
- Fasting period before study: overnight before dosing
- Housing: in groups of five rats of one sex in polythene breeding cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 degrees Celsius
- Humidity (%): 50-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 10/14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSE VOLUME APPLIED:
Pilot study: 0.85 - 7.6 mL
Main study: 6.0 - 12.0 mL - Doses:
- Pilot study: 40, 20, 10 and 5 ml/kg bw
Main study: 60, 42.4 and 30 ml/kg bw - No. of animals per sex per dose:
- Pilot study: 1 female and 1 male rat per dose
Main study: 5 female and 5 male rats per dose - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: immediately after dosing, 4 hours after dosing and then daily for 14 days
- Frequency of weighing: only immediately before dosing
- Necropsy of survivors performed: no - Statistics:
- The data obtained was subjected to statistical evaluation using the method of Litchfield and Wilcoxon (J. Pharm. Exp. Therap. 1949, 95, 99)
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 42 mL/kg bw
- Based on:
- test mat.
- Remarks:
- (aqueous solution)
- 95% CL:
- >= 33 - <= 53
- Mortality:
- Pilot study:
20, 10 and 5 ml/kg: none of the rats died
40 ml/kg: the female rat dosed at this level died 24 hours after dosing
Main study:
60 ml/kg: one male and 2 female rats died within 4 hours of dosing. The remaining rats died within 24 hours of dosing.
42.4 ml/kg: two female rats died within 24 hours and 1 male rat died within 48 hours.
30 ml/kg: two of the male rats died within 24 hours - Clinical signs:
- other: lethargy, hunched stance
- Gross pathology:
- no data
- Other findings:
- no data
Any other information on results incl. tables
Dose level; aqueous solution (mL/kg) |
No. of rats |
Sex (M or F) |
Average Bodyweight (g); immediately before dosing |
Volume dosed (mL) |
Mortality |
||||
0-4 hrs. |
1-7 days |
8-14 days |
Total |
||||||
40.0 |
1 |
M |
190 |
7.6 |
0 |
0 |
0 |
0 |
1/2 |
1 |
F |
180 |
7.2 |
0 |
1 |
- |
1 |
||
20.0 |
1 |
M |
180 |
3.6 |
0 |
0 |
0 |
0 |
0/2 |
1 |
F |
170 |
3.4 |
0 |
0 |
0 |
0 |
||
10.0 |
1 |
M |
170 |
1.7 |
0 |
0 |
0 |
0 |
0/2 |
1 |
F |
170 |
1.7 |
0 |
0 |
0 |
0 |
||
5.0 |
1 |
M |
170 |
0.85 |
0 |
0 |
0 |
0 |
0/2 |
1 |
F |
175 |
0.88 |
0 |
0 |
0 |
0 |
||
60.0 |
5 |
M |
200 |
12 |
1 |
4 |
- |
5 |
10/10 |
5 |
F |
190 |
11.4 |
2 |
3 |
- |
5 |
||
42.4 |
5 |
M |
220 |
9.3 |
0 |
1 |
0 |
1 |
3/10 |
5 |
F |
200 |
8.5 |
0 |
2 |
0 |
2 |
||
30.0 |
5 |
M |
250 |
7.5 |
0 |
2 |
0 |
2 |
2/10 |
Pilot study:
20, 10 and 5 ml/kg: none of the rats died or showed any overt signs of toxicity throughout the 14 -day test period.
40 ml/kg: the female rat dosed at this level became lethargic 4 hours after dosing and died 24 hours after dosing. The male rat was lethargic for 48 hours after dosing, but showed no further overt signs of toxicity
Main study:
60 ml/kg: one male and 2 female rats died within 4 hours of dosing. The remaining rats were lethargic at the 4 hour observation period and died within 24 hours of dosing.
42.4 ml/kg: all the rats became lethargic and adopted a hunched stance within 4 hours of dosing. Two female rats died within 24 hours and 1 male rat died within 48 hours.
30 ml/kg: 3 male rats became lethargic within 24 hours. Two of these 3 rats died 24 hours later.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 oral (rat): 42 ml/kg (aqueous solution)
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