Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 800-526-8 | CAS number: 1273322-45-4
- 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:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- C16-18-(even numbered)-alkylamines acetates
- EC Number:
- 800-526-8
- Cas Number:
- 1273322-45-4
- Molecular formula:
- R-NH2xHOOCCH3 R = alkyl, mainly C16-18-(even numbered)
- IUPAC Name:
- C16-18-(even numbered)-alkylamines acetates
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Number of animals: 3 per step
Age
at the beginning of the study: 9 - 10 weeks old
Body weight
on the day of administration: Step 1 / animals no. 1 - 3: 158 – 177 g;
Step 2 / animals no. 4 - 6: 150 – 152 g
The animals were derived from a controlled full barrier maitained breeding system(SPF). According to Art. 9.2, No. 7 of the German act on animal welfare the animals were bred for experimental purposes.
Environmental 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 (lot no. 1455)
-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 (lot no. 060411)
-Certificates of food, water and bedding are filed at BSL BIOSERVICE
-Adequate acclimatisation period (at least five days) under laboratory conditions
The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 060411)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube
The test item was administered at a dose volume of 10 mL/kg body weight
Preparation of Dose Formulation:
For all animals of the first and second step, 2 g of the test item were emulsified in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight. - Doses:
- The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
- No. of animals per sex per dose:
- 3 Animals per step (2 steps were used)
- Control animals:
- no
- Details on study design:
- Preparation of Animals:
The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access
to water was permitted). Following the period of fasting the animals were weighed and the
test item was administered. Food was provided again approximately 4 hours post dosing.
Opservation Period:
All animals were observed for 14 days after dosing for general clinical signs, morbidity and
mortality.
Weight Assessment:
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination:
A careful clinical examination was made several times on the day of dosing (at least once
during the first 30 minutes and with special attention given during the first 4 hours post-dose).
As soon as symptoms were noticed they were recorded. Thereafter, the animals were
observed for clinical signs once daily until the end of the observation period.
Pathology:
At the end of the observation period the animals were sacrificed with an overdosage of
pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no.: 212041; expiry date:
04/2014) at a dosage of approximately 8 mL/kg bw.
All animals were subjected to gross necropsy. All gross pathological changes were recorded
Evaluation of Results
Results were interpreted according to OECD Guideline 423, Annex 2(see also flow charts in the appendix of the study plan).
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by dose level.
Nature, severity and duration of clinical observations were described.
Body weight changes were summarised in tabular form.
Necropsy findings were described.
On the basis of the test results, the test substance may be classified in any of the following classes in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC:
·
Substances and preparations shall be classified as very toxic, and assigned the symbol “T+” and indication of danger “very toxic” in accordance with the criteria specified below:
R28 Very toxic if swallowed
- LD50 oral, rat£25 mg/kg
- less than 100% survival at 5 mg/kg oral, rat by the fixed dose procedure, or
- high mortality at doses£25 mg/kg oral, by the acute toxic class method.
·
Substances and preparations shall be classified as toxic, and assigned the symbol “T” and indication of danger “toxic” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R25 Toxic if swallowed
- LD50 oral, rat 25 < LD50£200 mg/kg
- discriminating dose, oral rat 5 mg/kg: 100% survival but evident toxicity, or
- high mortality in the dose range > 25 to£200 mg/kg oral, rat, by the acute toxic class method.
·
Substances and preparations shall be classified as harmful, and assigned the symbol “Xn” and indication of danger “harmful” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R22 Harmful if swallowed
- LD50 per oral, rat 200 < LD50£2000 mg/kg
- discriminating dose, oral rat, 50 mg/kg: 100% survival but evident toxicity,
- less than 100% survival at 500 mg/kg, rat oral by the fixed dose procedure, or
- high mortality in the dose range > 200 to£2000 mg/kg oral, rat, by the acute toxic class method.
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given inAnnex I of Regulation (EC) 1272/2008:
Category 1:LD50£5 mg/kg. DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 2:LD50 > 5 mg/kg£50 mg/kg. DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 3:LD50 > 50 mg/kg£300 mg/kg. DANGER. Skull and crossbones in diamond. Toxic if swallowed.
Category 4:LD50 > 300 mg/kg£2000 mg/kg. WARNING. Exclamation point in diamond. Harmful if swallowed.
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given inGHS- Globally Harmonized System of Classification and Labelling of Chemicals, third revised edition, July 2009:
Category 1:LD50£5 mg/kg DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 2:LD50 > 5 mg/kg£50 mg/kg DANGER. Skull and crossbones in diamond. Fatal if swallowed.
Category 3:LD50 > 50 mg/kg£300 mg/kg. DANGER. Skull and crossbones in diamond. Toxic if swallowed.
Category 4:LD50 > 300 mg/kg£2000 mg/kg. WARNING. Exclamation point in diamond. Harmful if swallowed.
Category 5:LD50 > 2000 mg/kg£5000 mg/kg. WARNING. No symbol. May be harmful if swallowed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in this study
- Clinical signs:
- other: The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were initially reduced spontaneous activity, piloerection, half eyelid-closure, moving the bedding, closed eyes, feeding on bedding, body weight loss.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item C16-18-(even numbered)-alkylamines acetates to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity, but no mortality.
The median lethal dose of C16-18-(even numbered)-alkylamines acetates after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item C16-18-(even numbered)-alkylamines acetates has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item C16-18-(even numbered)-alkylamines acetates has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item C16-18-(even numbered)-alkylamines acetates has obligatory labelling requirement for toxicity and is classified into Category 5. - Executive summary:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was emulsified in the vehicle sesame oil at a concentration of 0.4 g/mL and administered at a dose volume of 10 mL/kg. All animals used in the study were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs.
During the study period, all animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were initially reduced spontaneous activity, piloerection, half eyelid-closure, moving the bedding, closed eyes,feeding on bedding, body weight loss. All clinical signs were reversible on a short-term basis. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with reversible signs of toxicity, but no mortality. The median lethal dose (LD50 cut-off) of the registration substance observed over a period of 14 days was 5000 mg/kg body weight.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.