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EC number: 304-990-8 | CAS number: 94313-91-4
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- Appearance / physical state / colour
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- Endpoint summary
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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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
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- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The NOEL in a 90 day sub-chronic dietary study in the rat was 3000 ppm. The NOEL in a 90 day sub-chronic study with a similar substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate) in the dog was 75 mg/kg (top dose limited by the palatability of the substance in the diet).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- The study is very similar to a standard guideline study. However it was conducted prior to OECD guideline and GLP. No analysis of test substance in diet was conducted. There was no statistical analysis of the results. Full details of the study are not reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- No ophthalmological examination and no functional observations. Limited haematology, clinical chemistry and pathology.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carworth Farms, Rockland, NY
- Weight at study initiation: Average body weight for both sexes of 42g
- Housing: Individual cages
- Water (e.g. ad libitum): Ad libidum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 73
- Humidity (%): 40-60
- Air changes (per hr): 10 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Wayne Lab-Blox of Allied Mills Inc, Chicago, Illinois - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Continuosly in diet
- Remarks:
- Doses / Concentrations:
3000 ppm
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
1500 ppm
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
750 ppm
Basis:
nominal in diet - No. of animals per sex per dose:
- 20 males and 20 females
- Control animals:
- yes, plain diet
- Positive control:
- No
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule for examinations: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule for examinations: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Weekly
FOOD EFFICIENCY: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 45 and 90 days
- How many animals: 5 males and 5 females
- Parameters examined: Haematocrit %, total haemoglobin concentration, total and differential leukocyte counts, RBC morphology
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 45 and 90 days
- How many animals: 5 males and 5 females
- Parameters examined: urea nitrogen, alkaline phosphatase, glutamic oxaloacetic transaminase, fasting glucose
URINALYSIS: Yes
- Time schedule for collection of urine: 45 and 90 days
- Parameters examined: pH, specific gravity, glucose, protein, haemoglobin, presence of cells, casts and crystals
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes - thyroids, liver, kidneys, adrenals, testes
GROSS PATHOLOGY: Yes - skin, eyes, ears, mouth, fat, skeletal muscle, bone and marrow, salivary glands, thyroid, trachea, oesophagus, lung, heart, aorta, thymus, spleen, lymph nodes, pancreas, liver, stomach, small intestine, large intestine, caecum, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain
HISTOPATHOLOGY: Yes - skin, fat, skeletal muscle, bone and marrow, thyroid, parathyroid, trachea, oesophagus, lung, heart, aorta, spleen, pancreas, liver, stomach, small intestine, large intestine, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain - Statistics:
- Not reported
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- There were no treatment related effects reported.
- Dose descriptor:
- NOEL
- Effect level:
- 3 000 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
- Critical effects observed:
- not specified
- Conclusions:
- There were no treatment related effects following dietary dosing of the substance for 90 days to rats. Therefore the NOEL is 3000 ppm (calculated to be approximately equivalent to 279 mg/kg for males and 293 mg/kg for females).
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- The study is very similar to a standard guideline study. However it was conducted prior to OECD guideline and GLP. There was no statistical analysis of the results. Full details of the study are not reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)
- Deviations:
- yes
- Remarks:
- No ophthalmological examination. Limited clinical observations, haematology, clinical chemistry and pathology.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Antec Corporation, Leesburg, Virginia
- Age at study initiation: 6 months
- Housing: Individual cages
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One month
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 73
- Humidity (%): 46-65
- Air changes (per hr): 10 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The substance was incorporated into the diet then each dog was offered 30g/kg bw of basic diet, moistened with an equivalent amount of water containing the proper quantity of substance.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Daily for 90 days
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
75 mg/kg
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
25 mg/kg
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
10 mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 4 males and 4 females.
- Control animals:
- yes, plain diet
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Weekly
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Prior to initial feeding and after 12 weeks
- How many animals: All animals
- Parameters checked: haematocrit %, total haemoglobin concentration, total and differential leukocyte counts
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Prior to initial feeding and after 12 weeks
- How many animals: All animals
- Parameters checked: blood urea nitrogen, alkaline phosphatase, glutamic oxaloacetic transaminase, fasting glucose
URINALYSIS: Yes
- Parameters checked: appearance, protein, sugar, WBC, RBC
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes - thyroids, liver, kidneys, adrenals, testes
GROSS PATHOLOGY: Yes - skin, eyes, ears, mouth, fat, skeletal muscle, bone and marrow, salivary glands, thyroid, trachea, oesophagus, lung, heart, aorta, thymus, spleen, lymph nodes, pancreas, liver, gall bladder, stomach, small intestine, large intestine, caecum, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain
HISTOPATHOLOGY: Yes - skin, fat, skeletal muscle, bone and marrow, thyroid, parathyroid, trachea, oesophagus, lung, heart, aorta, spleen, pancreas, liver, stomach, small intestine, large intestine, adrenals, kidneys, urinary bladder, ovaries, testes, vagina, pituitary and brain - Statistics:
- Not reported
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- There were no treatment related effects reported.
- Dose descriptor:
- NOEL
- Effect level:
- 75 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: The top dose used in the study was limited by palatability
- Critical effects observed:
- not specified
- Conclusions:
- There were no treatment related effects following dietary dosing of the substance for 90 days to dogs. Therefore the NOEL is 75 mg/kg. The dose level was limited by the palatability of the substance in the diet.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 286 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 2.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are two 90 day sub-chronic studies available on a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS 10595-49-0), in the rat and dog. There were no treatment related effects in a 90 day sub-chronic feeding study in the rat at doses of up to 3000 ppm in diet (calculated to be approximately equivalent to 279 mg/kg for males and 293 mg/kg for females). Similarly there were no treatment related effects in a 90 day sub-chronic feeding study in the dog at doses of up to 75 mg/kg (top dose limited by the palatability of the substance in the diet). Both of the individual studies have limitations, for example they both precede standard protocol guidelines and GLP. In addition some aspects of the investigations are limited compared to current protocol standards. However taken together they provide a consistent picture of absence of repeated dose toxicity for this substance.
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
Two studies are available, both on a structural analogue. The
selected study was conducted in the rat and there is a larger toxicology
database available in the rat. In addition the dose levels in the dog
study were limited by the palatability of the substance in the diet
rather than by toxicity.
Justification for classification or non-classification
No treatment related effects were seen in 90 day sub-chronic studies in both the rat and the dog. Therefore there is no justification for classification of the substance for repeated dose toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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