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EC number: 619-057-3 | CAS number: 94667-33-1
- 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:
- 2 April 2001 to 4 May 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- EC Number:
- 619-057-3
- Cas Number:
- 94667-33-1
- Molecular formula:
- C29 H62 N O4 . C3 H5 O2
- IUPAC Name:
- bis(decyl)(2-hydroxyethyl)methylazanium propanoate
- Reference substance name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- IUPAC Name:
- alpha.-[2-(Didecylmethylammonio)ethyl]-.omega.-hydroxy-poly(oxy-1,2-ethanediyl) propionate
- Reference substance name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- IUPAC Name:
- N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate
- Reference substance name:
- Bardap 26
- IUPAC Name:
- Bardap 26
- Details on test material:
- The test substance was stored at room temperature and expected to be stable for the duration of testing (expiry date 12-12-2001).
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley rats were obtained from Ace Animals, Inc., Boyertown, Pennsylvania, USA, aged 8-12 weeks and weighing 204-234 g (males) and 150-184g (females). The animals were housed singly in suspended stainless steel cages, the temperature and relative humidity were 18-23°C and 35-72%, respectively, lighting was provided according to a 12 hour light/dark cycle. The rats were provided with food (Purina Rodent Chow #5012) ad libitum, except during fasting prior to dosing (approximately 18 hours pre-dose and 3.5 hours after dosing). Water (filtered tap water)was provided ad libitum. Rats in the range finding screen were acclimatised for 29 days; the test animals were acclimated for 10 days.
In-life dates of main test animals: 20 April to 4 May, 2001.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Individual doses were calculated based on initial body weights, taking into account the specific gravity of the test substance. Each rat received the appropriate amount of test substance as a single administration by gavage.
- Doses:
- 500, 1000, 2000, 4000 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- A range finding screen was conducted prior to the main test for selection of dose levels, with four male and four female rats. The test substance was administered to fasted rats at 500 and 2000 mg/kg bw. The animals were observed for 7 days after dosing. One male and one female from the 2000 mg/kg bw group died (50% mortality). Based on the range finding, dose levels of 500, 1000, 2000 and 4000 mg/kg bw were selected for the main test.
The observation period was 14 days. The rats were observed for clinical signs and mortality, and body weights were recorded. Gross necropsy was performed on rats that died during the study and on survivors at the end of the 14 day observation period. - Statistics:
- Moving Average Method was used to calculate the LD50.
Results and discussion
- Preliminary study:
- Range-finding: one male and one female from the 2000 mg/kg bw group died (50% mortality).
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 972 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 798 - <= 1 237
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 414 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 845 - <= 2 367
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 157 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 833 - <= 1 519
- Mortality:
- There were no mortalities at 500 mg/kg bw. There was a dose-related increase in mortality in the remaining groups:
1000 mg/kg bw: 4/10 (3/5 males; 1/5 females), 2000 mg/kg bw: 9/10 (5/5 males; 4/5 females), and 4000 mg/kg bw: 10/10 (5/5 males; 5/5 females). Mortalities in the 1000 and 2000 mg/kg bw groups occurred within 7 days of administration, and within 2 days of administration in the 4000 mg/kg/ bw group. - Clinical signs:
- other: 500 mg/kg bw: most rats exhibited ocular discharge, hunched posture, hypoactivity, ano-genital staining, soft faeces, diarrhoea and/or reduced faecal volume. All animals recovered by Day 10. 1000 mg/kg bw: clinical signs in the 3 males and 1 female that
- Gross pathology:
- No gross abnormalities were observed in the animals that survived to study termination. Necropsy of the animals that died following administration of 1000 mg/kg bw revealed discolouration of the lungs, liver and intestines and/or gaseous distention of the intestines. Necropsy of the animals that died following administration of 2000 mg/kg bw revealed discolouration of the lungs, liver and/or intestines, and in one male the stomach was filled with fluid and the lungs were oedematous. Necropsy of the 4000 mg/kg bw group revealed discolouration of the lungs, liver and/or intestines, oedema of the lungs, fluid-filled stomach, gaseous distention of the intestines and/or rigor mortis.
- Other findings:
- No other findings were reported.
Any other information on results incl. tables
Table 1. Group incidence of mortality
Dose level |
Mortality# |
||
Male |
Female |
Total |
|
500 |
0/5 |
0/5 |
0/10 |
1000 |
3/5 |
1/5 |
4/10 |
2000 |
5/5 |
4/5 |
9/10 |
4000 |
5/5 |
5/5 |
10/10 |
# Number dead/total number in group
Table 2. Group incidence of clinical signs (number affected/total number in group)
Clinical signs |
Dose level (mg/kg bw) |
|||
500 |
1000 |
2000 |
4000 |
|
Ocular discharge |
1/10 |
2/10 |
1/10 |
0/10 |
Hunched/abnormal posture |
1/10 |
2/10 |
7/10 |
3/10 |
Hypoactivity |
1/10 |
5/10 |
10/10 |
10/10 |
Ano-genital staining |
6/10 |
7/10 |
9/10 |
5/10 |
Soft faeces |
2/10 |
4/10 |
2/10 |
0/10 |
Diarrhoea |
1/10 |
3/10 |
9/10 |
5/10 |
Reduced faecal volume |
7/10 |
10/10 |
5/10 |
3/10 |
Facial staining |
0/10 |
1/10 |
2/10 |
0/10 |
Irregular/shallow breathing |
0/10 |
1/10 |
4/10 |
6/10 |
Piloerection |
0/10 |
1/10 |
2/10 |
1/10 |
Distended abdomen |
0/10 |
1/10 |
0/10 |
0/10 |
Prone |
0/10 |
0/10 |
1/10 |
6/10 |
Table 3. Group mean body weight (g)
|
Dose level (mg a.s./kg) |
|||||||
500 |
1000 |
2000 |
4000 |
|||||
M |
F |
M |
F |
M |
F |
M |
F |
|
0 |
215 |
175 |
221 |
176 |
219 |
165 |
213 |
170 |
7 |
235 |
209 |
235 |
187 |
a/d |
178 |
a/d |
a/d |
14 |
294 |
244 |
305 |
221 |
a/d |
211 |
a/d |
a/d |
M: male
F: female
a/d: all dead
Table 4. Group incidence of gross findings at necropsy
Gross findings# |
Dose level (mg a.s./kg) |
|||
500 |
1000 |
2000 |
4000 |
|
No abnormalities |
10/10 |
6/10 |
1/10 |
0/10 |
Lungs |
||||
Slightly red |
0/10 |
0/10 |
2/10 |
2/10 |
Slightly red, oedematous |
0/10 |
0/10 |
1/10 |
4/10 |
Moderately red |
0/10 |
4/10 |
7/10 |
4/10 |
Liver |
||||
Discolouration |
0/10 |
4/10 |
5/10 |
8/10 |
Intestines |
||||
Slightly red |
0/10 |
0/10 |
1/10 |
4/10 |
Slightly red, gaseous distention |
0/10 |
2/10 |
0/10 |
0/10 |
Red, gaseous distention |
0/10 |
0/10 |
0/10 |
4/10 |
Red |
0/10 |
0/10 |
5/10 |
0/10 |
Red/green |
0/10 |
2/10 |
0/10 |
0/10 |
Black/green/red |
0/10 |
0/10 |
3/10 |
0/10 |
Stomach |
||||
Filled with fluid |
0/10 |
0/10 |
1/10 |
6/10 |
General appearance |
||||
Rigor mortis |
0/10 |
0/10 |
0/10 |
4/10 |
# Gross
abnormalities seen only in decedents
Number of animals affected/total number in group
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The combined sexes LD50 is 1157 mg/kg bw. The test substance is therefore classified as H302: Harmful if Swallowed according to Regulation (EC) No 1272/2008.
- Executive summary:
The acute oral toxicity of Bardap 26 was determined in male and female Sprague-Dawley rats. The test substance was administered by gavage to groups of 5 rats/sex at doses of 500, 1000, 2000 and 4000 mg/kg bw. The rats were observed for clinical signs, mortality and body weights changes for 14 days after administration. Gross necropsy was performed on rats that survived to study termination and those that died during the study.
There was a dose-related increase in mortality; 3/5 males and 1/5 females in the 1000 mg/kg bw groups died within 7 days of administration; 5/5 males and 4/5 females in the 2000 mg/kg bw group died within 7 days of administration; all animals (5 males and 5 females) in the 4000 mg/kg bw group died within 2 days of administration. Clinical signs included hypoactivity, irregular/shallow breathing, ano-genital staining and diarrhoea. Gross necropsy findings in decedents included discoloured liver, red lungs, black/green/red intestines and fluid-filled stomach. The LD50 for male rats was 972 mg/kg (95% confidence limits: 798-1237 mg/kg bw); the LD50 for female rats was 1414 mg/kg bw (95% confidence limits: 845-2367 mg/kg bw); and the LD50 for both sexes combined was 1157 mg/kg bw (95% confidence limits: 833-1519 mg/kg bw). The substance is therefore classified as H302: Harmful if Swallowed according to Regulation (EC) No 1272/2008.
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