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EC number: 245-509-0 | CAS number: 23235-61-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June - August 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No reference is made to official Test Guidelines and no claim is made to GLP compliance. Furthermore, there is no reference to the purity of the substance. However, the species tested is relevant to the endpoint, the study report is well documented and its design appears to be in the spirit of the current guideline. The study is adequate for the purposes of hazard identification and classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- A preliminary range-finding test was performed to determine the approximate range in which the median lethal oral dose (LD50) fell. The subsequent main study involved testing of a larger number of animals to determine the LD50 value more precisely.
- GLP compliance:
- not specified
- Remarks:
- : older study, pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- EC Number:
- 245-509-0
- EC Name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- Cas Number:
- 23235-61-2
- Molecular formula:
- C12H26O5
- IUPAC Name:
- 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): DI-TMP
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 18 to 23 g.
- Fasting period before study: animals were fasted overnight before treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqueous methylcellulose 1%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40% (w/v)
- Amount of vehicle (if gavage): 40 mL/kg (control group, vehicle only); 10 to 40 mL/kg (treatment groups).
MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg. - Doses:
- 0.4, 1.0, 4.0, 16 g/kg. (range finding screen)
0, 4.0, 6.4, 10, 16 g/kg. (main study) - No. of animals per sex per dose:
- 2 (range finding screen)
5 (main study) - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: wieghts recorded weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: macrosopic examination of target organs. - Statistics:
- The LD50 and its 95% confidence limits were calculated by the method of Litchfield J.T. and Wilcoxon F. (1949) J. Pharmac. Exp. Ther, 96, 99-113.
Results and discussion
- Preliminary study:
- The preliminary range finding tests indicated that the median lethal oral dose (LD50) was in the region of 4.0 to 16 g/kg.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14 500 mg/kg bw
- 95% CL:
- >= 11.2 - <= 18.7
- Mortality:
- One male and one female mouse died at 10 g/kg; three male and three female mice died at 16 g/kg. Deaths occurred within three hours to 23 hours
after dosing. - Clinical signs:
- other: Signs of reaction to treatment, observed shortly after dosing included piloerection in all treated animals, abnormal body carriage (hunched posture) and ptosis in animals treated at 6.4 g/kg and above and lethargy decreased respiratory rate and abnormal g
- Gross pathology:
- In the mice which died during the observation period, autopsy revealed haemorrhage and congestion of the lungs and pallor of the liver, kidneys and
spleen. - Other findings:
- - Other observations: Prior to death loss of righting reflex was observed in threee mice at 16 g/kg. Piloerection only was observed in the control mice.
Any other information on results incl. tables
Mortality data for groups of mice dosed orally with DI-TMP
Range Finding Screen
Dosage (g/kg) |
Mortality ratio (No. of deaths / No. dosed) |
Time of death after dosing (Hours) |
|||
Concentration % |
Male |
Female |
Combined |
||
0.4 |
10 |
0/2 |
0/2 |
0/4 |
- |
1.0 |
10 |
0/2 |
0/2 |
0/4 |
- |
4.0 |
40 |
0/2 |
0/2 |
0/4 |
- |
16 |
40 |
1/2 |
2/2 |
3/4 |
<20 |
Mortality ratio and group mean bodyweight (g) of mice dosed orally with DI-TMP
Main study
Sex |
Dosage (g/kg) |
Bodyweight (g) at |
Mortality ratio (No. of deaths / No. dosed) |
Time of death after dosing (Hours) |
||
dosing |
1 week |
2 weeks |
||||
Male |
0 |
21 |
30 |
34 |
0/5 |
- |
4.0 |
20 |
30 |
36 |
0/5 |
- |
|
6.4 |
21 |
29 |
32 |
0/5 |
- |
|
10 |
20 |
30 |
33 |
1/5 |
<4 |
|
16 |
22 |
31 |
36 |
3/5 |
<4 |
|
Female |
0 |
20 |
25 |
27 |
0/5 |
- |
4.0 |
19 |
25 |
26 |
0/5 |
- |
|
6.4 |
19 |
25 |
27 |
0/5 |
- |
|
10 |
21 |
26 |
28 |
1/5 |
<23 |
|
16 |
19 |
23 |
36 |
3/5 |
<4 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) and its 95% confidence limits to mice of DI-TMP were calculated to be 14.5 (11.2 to 18.7) g/kg bodyweight.
- Executive summary:
A study was performed by Huntingdon Research Centre, England on behalf of Perstorp Chemicals, Sweden to determine the acute oral toxicity to CD-1 mice of the test substance DI-TMP. No official Test Guidelines were cited, however the study design and species used were relevant and broadly in line with modern test guidelines. The LD50 in mice of the test substance was found to be 14.5 g/kg bodyweight (95% confidence limits 11.2 to 18.7 g/kg bodyweight).
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