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EC number: 304-990-8 | CAS number: 94313-91-4
- 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
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- EC Number:
- 304-990-8
- EC Name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- Cas Number:
- 94313-91-4
- Molecular formula:
- C17H35N2O.CH3O4S
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Test material form:
- other: Liquid
- Details on test material:
- The test material was a 47% aqueous solution of the substance
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: m: 125 - 135g; f: 110 - 125g
- Fasting period before study: over night
- Housing: single caging, cage type: Macrolon type IlI./max. 5
- Diet: ad libitum; rat diet (R 4 Alleindiät für Ratten), Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water: ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
The test substance was weighed out in a glass, then was filled with Aqua destillata up to the desired volume, was shaken well and afterwards labeled. The formulated test substance was a clear solution. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- The group of 5 female and 5 male rats were were given a single oral dose 5000 mg/kg of the test substance by gavage.
- Duration of observation period following administration: 14 d
- Body weights were recorded before treatment (day -1), at the treatment day (day 0), and on days 7 and 14 after treatment
- Clinical observation: Animals were observed 1/4 h, 1/2 h, 1 h, 2 h, 4 h after dosing and thereafter once daily up to day 14.
- Necropsy of the survivors performed: yes - Statistics:
- As none of the test animals died a calculation of the LD50 was not possible.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: based on product; mortality 0/10
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 350 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: based on a.i.; mortality 0/10
- Mortality:
- There were no mortalities
- Clinical signs:
- other: Except of ruffled fur on the day of treatment, the animals were free of clinical-/toxicological symptoms during the entire observation period of 14 days.
- Gross pathology:
- Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of the test material was >5000 mg/kg bw (47% a.i.), equivalent to LD50 > 2350 mg/kg bw (100% a.i.)
- Executive summary:
In an acute oral toxicity study similar to OECD Guideline 401 (1981) 5 male and 5 female Sprague-Dawley rats were given a single dose of the substance (a.i. 47 %) at a dose of 5000 mg/kg bw (limit test). The test item was formulated in water and applied in a volume of 10 mL/kg bw. Animals were subsequently observed for 14 consecutive days.There were no deaths following a single oral dose of the substance. Except of ruffled fur on the day of treatment, the animals were free of clinical/ toxicological signs during the entire observation period of 14 days. Necropsies were performed on all animals at the end of the 14-day observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound-related macroscopic findings in the cranial-, thoracic- and abdominal cavity.
Oral LD50Combined: > 2350 mg/kg bw (active ingredient)
LD50 > 5000 mg/kg bw determined in the study report refers to the test substance as delivered by the sponsor. Amount of active ingredient in test substance is 47 % according to the sponsor information. Therefore the calculated oral LD50 combined referring to 100 % active substance is 2350 mg/kg bw. The substance is practically nontoxic based on LD50 in males and females.
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