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EC number: 615-231-8 | CAS number: 70983-58-3
- 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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
- EC Number:
- 615-231-8
- Cas Number:
- 70983-58-3
- Molecular formula:
- UVCB
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
- Test material form:
- liquid: viscous
- Details on test material:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Constituent 1
- Specific details on test material used for the study:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test System
Species/strain: WISTAR rats Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at the beginning of the study: 8-12 weeks
Body weight on the day of administration:
step 1, animals no. 1-3: 195 - 217 g
step 2, animals no. 4-6: 180 - 220 g
step 3: animasl no. 7-9: 173 – 185 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare [9] the animals were bred for experimental purposes. This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 +- 3 °C
- Relative humidity: 55 +- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube. The test item was administered undiluted.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat. (total fraction)
- Mortality:
- The test item showed mortality and other acute oral toxicity characteristics after a single dose administration at a dosage of 2000 mg/kg body weight. With a dosage of 300 mg/kg body weight the test item showed slight signs of toxicity but no mortality.
- Clinical signs:
- other: The test item showed mortality and other acute oral toxicity characteristics after a single dose administration at a dosage of 2000 mg/kg body weight. With a dosage of 300 mg/kg body weight the test item showed slight signs of toxicity but no mortality.
- Gross pathology:
- The necropsy of the animals dosed with 2000 mg/kg bw revealed a dark discoloured liver. At necropsy the livers were already autolytic.
The necropsy of the animals dosed with 300 mg / kg bw revealed no specific findings.
Any other information on results incl. tables
Results
The test item showed mortality and other acute oral toxicity characteristics after a single dose administration at a dosage of 2000 mg/kg body weight. With a dosage of 300 mg/kg body weight the test item showed slight signs of toxicity but no mortality.
Table 1: Clinical Signs - Individual Data
Step | Starting dose (mg/kg bw) | Animal No. / Sex | Timepoint | Observation |
1 | 2000 | 1 / Female | 0 - 120 min | nsf |
1 | 2000 | 1 / Female | 120 - 180 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection, half eyelid closure |
1 | 2000 | 1 / Female | 180 - 240 min | Moderately reduced Spontaneous activity, hunched posture, moderate piloerection , half eyelid closure, sunken flanks |
1 | 2000 | 1 / Female | 240 min - d 2 | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, eyes closed, sunken flanks, slight diarrhoea |
1 | 2000 | 1 / Female | d 2 | found dead |
1 | 2000 | 2 / Female | 0 - 120 min | nsf |
1 | 2000 | 2 / Female | 120 - 180 min | Slightly reduced spontaneous activity, hunched posture, slight piloerection, half eyelid closure |
1 | 2000 | 2 / Female | 180 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection , half eyelid closure, sunken flanks |
1 | 2000 | 2 / Female | 240 min - d 2 | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, eyes closed, Sunken flanks |
1 | 2000 | 2 / Female | d 2 | found dead |
1 | 2000 | 3 / Female | 0 - 120 min | nsf |
1 | 2000 | 3 / Female | 120 - 180 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid closure, sunken flanks |
1 | 2000 | 3 / Female | 180 - 240 min | Moderately reduced spontaneous activity, hunched posture, moderate piloerection, eyes closed, sunken flanks |
1 | 2000 | 3 / Female | 240 min - d 2 | found dead |
Table 2: Clinical Signs - Individual Data
Step | Starting dose (mg/kg bw) | Animal No. | Timepoint | Observation |
2 | 300 | 4 / Female | 0 - 180 min | nsf |
2 | 300 | 4 / Female | 180 - 240 min | Hunched posture, moderate piloerection |
2 | 300 | 4 / Female | 240 min - 2 d | Hunched posture, moderate piloerection, half eyelid closure |
2 | 300 | 4 / Female | d 2 - d 15 | nsf |
2 | 300 | 5 / Female | 0 - 180 min | Hunched posture, moderate piloerection |
2 | 300 | 5 / Female | 180 - 240 min | Hunched posture, moderate piloerection, half eyelid closure |
2 | 300 | 5 / Female | 240 min - 2 d | nsf |
2 | 300 | 5 / Female | d 2 - d 15 | nsf |
2 | 300 | 6 / Female | 0 - 180 min | nsf |
2 | 300 | 6 / Female | 180 - 240 min | Hunched posture, moderate piloerection |
2 | 300 | 6 / Female | 240 min - 2 d | Hunched posture, moderate piloerection, half eyelid closure |
2 | 300 | 6 / Female | d 2 - d 15 | nsf |
3 | 300 | 7 / Female | 0 min – d 15 | nsf |
3 | 300 | 8 / Female | 0 min – d 15 | nsf |
3 | 300 | 9 / Female | 0 min – d 15 | nsf |
Based on these results and according to the acute toxic class method regime no further testing was required. Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item is provided.
Body Weight Development
None of the animals showed weight loss during the observation period.
Table 3: Absolute Body Weights in g and Body Weight Gain in %
Step | Animal No. / Sex | Starting material (mg/kg bw) | BW (g) | Body weight in comparison to day 1 (%) | ||
Day 1 | Day 8 | Day 15 | 15 | |||
Step 1 | 1 / Female | 2000 | 197 | found dead on day 2 | ||
Step 1 | 2 / Female | 2000 | 217 | found dead on day 2 | ||
Step 1 | 3 / Female | 2000 | 195 | found dead on day 2 | ||
Step 2 | 4 / Female | 300 | 214 | 237 | 240 | 12 |
Step 2 | 5 / Female | 300 | 220 | 246 | 248 | 13 |
Step 2 | 6 / Female | 300 | 180 | 194 | 203 | 13 |
Step 3 | 7 / Female | 300 | 184 | 202 | 220 | 20 |
Step 3 | 8 / Female | 300 | 173 | 180 | 200 | 16 |
Step 3 | 9 / Female | 300 | 185 | 215 | 217 | 17 |
Pathology
The necropsy of the animals dosed with 2000 mg/kg bw revealed a dark discoloured liver. At necropsy the livers were already autolytic. The necropsy of the animals dosed with 300 mg / kg bw revealed no specific findings.
Table 4: Findings of the Necropsy - Individual Data
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Organ | Macroscopic Findings |
Step 1 | 1 / Female | 2000 | Liver | Discoloured, dark* |
Step 1 | 2 / Female | 2000 | Liver | Discoloured, dark* |
Step 1 | 3 / Female | 2000 | Liver | Discoloured, dark* |
Step 2 | 4 / Female | 300 | - | nsf |
Step 2 | 5 / Female | 300 | - | nsf |
Step 2 | 6 / Female | 300 | - | nsf |
Step 3 | 7 / Female | 300 | - | nsf |
Step 3 | 8 / Female | 300 | - | nsf |
Step 3 | 9 / Female | 300 | - | nsf |
bw = body weight; nsf = no specific findings; * = autolytic
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 500 mg/ kg bw.
- Executive summary:
In a Klimisch 1 OECD 423 GLP study a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity and mortality.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 300 mg/kg body weight was associated with slight signs of toxicity but not with mortality.
The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 500 mg/ kg bw.
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