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EC number: 291-707-5 | CAS number: 90459-62-4
- 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
- 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:
- 04 October 2018 - 31 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted: 17th December 2001
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- EC Number:
- 291-707-5
- EC Name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- Cas Number:
- 90459-62-4
- Molecular formula:
- C24H55N3O6S
- IUPAC Name:
- bis(2-aminoethyl)amine octadecanoic acid dimethyl sulfate
- Test material form:
- solid
- Remarks:
- paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals; Animal Facility, Bioneeds India Private Limited, Devarahosahally, Sompura Hobli, Nelamangala Taluk, Bangalore Rural District, PIN - 562 111, Karnataka, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 163.87 g to 177.26 g
- Fasting period before study: fasted overnight (16 to 18 hours) prior to dosing and 3 to 4 hours after dosing
- Housing: three animals per group in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm) with stainless steel mesh top grill
- Diet (e.g. ad libitum): Altromin Maintenance diet for rats and mice 1324, ad libitum
- Water (e.g. ad libitum): deep bore-well water passed through Reverse osmosis unit, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1°C to 22.7°C
- Humidity (%): 49% to 66%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% w/v Carboxy Methyl Cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 or 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
A starting dose of 300 mg/kg body weight has been selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight as there is no available information on the LD50 of the test item.VEHICLE
- Doses:
- 300, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females for each Step-I, Step-I confirmation and Step-II, Step-II confirmation
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Individual animal body weight will be recorded at receipt, on day 1 before test item administration and on day 8 and 15 during the observation period. If the animal is found dead, then the body weight of dead animal will be recorded.
All the animals will be observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) post dosing on Day 1 and at least once daily thereafter for clinical signs of toxicity throughout the experimental period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality was observed at 300 or 2000 mg/kg bw.
- Clinical signs:
- In Step-I, Step-I confirmation and Step-II, Step-II confirmation, the animals were dosed at 300 mg/kg body weight and in Step-II, Step-II confirmation at 2000 mg/kg body weight. No clinical signs of toxicity were observed.
- Body weight:
- No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg and 2000 mg/kg body weight.
- Gross pathology:
- No gross pathological changes were observed in any of the animals at 300 mg/kg and 2000 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the experiment, it is concluded that the LD50 cut off value for the test item Leomin KP was 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method”.
- Executive summary:
The test item Leomin KP was evaluated for acute oral toxicity in Sprague Dawley rats as per OECD Guideline No. 423: Acute Oral Toxicity - Acute Toxic Class Method adopted on 17 December 2001.
A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight as there is no available information on the LD50 of the test item.
A total of 12 females (3 females for each Step-I, Step-I confirmation and Step-II, Step-II confirmation) were used for the experiment. All the animals of Step-I, Step-I confirmation were administered with 300 mg/kg body weight of the test item and Step-II, Step-II confirmation were administered with 2000 mg/kg body weight of the test item by oral route.
All the animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on Day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were sacrificed under carbon dioxide anaesthesia, subjected to necropsy and gross pathological examination.
No clinical signs of toxicity and mortality were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight.
No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg and 2000 mg/kg body weight. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight.
Conclusion
Based on the results of the experiment, it is concluded that the LD50 cut off value for the test item Leomin KP was 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals (No. 423, Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Acute Toxic Class Method”.
The substance is not classified according to EU GHS criteria.
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