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EC number: 629-721-4 | CAS number: 308062-60-4
- 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
Endpoint summary
Administrative data
Description of key information
Two acute studies are available on Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4), one on acute oral toxicity and one on acute dermal toxicity.
The oral LD50 study on Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 has reliability rating 2 and is compliant to OECD Guideline 401. The reason for the reliability rating 2 is the study was performed pre-GLP in 1987 and no specific certificate of analysis or information on batch is included in the report. The result from this study is considered to be reliable, since the product tested has not changed significantly in its composition since the testing was carried out. Therefore the results are considered valid for the current manufactured Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 and the study will be used for classification of the substance.
The dermal LD50 study (OECD Guideline 402) on Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 study has reliability 1 GLP .
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP, but inhouse quality insurance was in place
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England.
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 101-122g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: in groups by sex in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum, standard laboratory rodent diet (Labsure LAD 1)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: The study was undertaken between 8 and 22 May 1987. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 10.0 ml/kg max.
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED:
10.0 ml/kg
DOSAGE PREPARATION (if unusual):
No data, the dosage was prepared on the day of dosing. - Doses:
- Preliminary and main study: 5000 mg/kg bw
- No. of animals per sex per dose:
- Preliminary study: 2
Main study: 5 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5days, preliminary study and 14 days, main study
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On
subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation. Individual bodyweights of rats on Days 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:- - Statistics:
- None
- Preliminary study:
- No mortality at 5000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality at 5000 mg/kg bw
- Clinical signs:
- other: Pilo-erection was observed in all rats shortly after dosing. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by Day 2.
- Gross pathology:
- No effects observed
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD50 of Bis (hydrogenated tallowalkyl) amine is greather than 5000 mg/kg bw.
- Executive summary:
According to OECD401 rats were exposed to 5000 mg/kg bw. No deaths occured and no significant other effects were observed. The LD50 of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is greather than 5000 mg/kg bw.
Reference
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 23-Sep-2009 and 13-Oct-2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test System
Animals: Rat, RccHan: WIST(SPF)
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan Laboratories B.V. Kreuzelweg 53 5961 NM Horst / The Netherlands Postbus 6174 5960 AD Horst / The Netherlands
Number of Animals per Group: 5 males and 5 females
Total Number of Animals: 5 males and 5 females
Age (when treated): Males: 9 weeks Females: 11 weeks
Body Weight Range (when treated): 246.3 g – 256.0 g (males) 194.5 g – 201.2 g (females)
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Allocation
The animals were distributed as follows:
Dose Level Sex Group Animal Number
2000 mg/kg M 1 1-5
2000 mg/kg F 2 6-10
Husbandry
Room Number: 0105 / Harlan Laboratories Ltd., Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70% (values above 70% during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding (‘Lignocel’ J. Rettenmaier&Söhne GmbH&CoKG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) during treatment and observation.
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 30/09 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum.
Results of analyses for contaminants are archived at Harlan Laboratories Ltd.
Water: Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at Harlan Laboratories Ltd. - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface.
Only those animals without injury or irritation on the skin were used in the test.
Vehicle
The following information was provided by Harlan Laboratories Ltd.:
Identification: Corn oil
Description: Yellowish oily liquid
Batch Number: 049103168
Source: Carl Roth GmbH & Co. 76185 Karlsruhe / Germany
Stability of the Vehicle: Stable under storage conditions
Expiry Date: 31-Jan-2014
Storage Conditions: At room temperature (range of 20 ± 5 °C), light protected.
Safety Precautions: Routine hygienic procedures were used to ensure the
health and safety of the personnel.
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the statement of compliance.
Preparation of Dose Formulations
Dose levels are in terms of the test item as supplied by the Sponsor. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The formulation was prepared shortly before the application using a magnetic stirrer, a spatula and an Ultra-Turrax as homogenizers. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a surgical gauze pad (ca. 5 x 5 cm) held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen.
The application volume was 6 mL/kg.
After the 24-hour application period, the dressing was removed and the skin was flushed with lukewarm water and drapped off with disposable paper towels. The skin reaction was assessed. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- PURPOSE
The purpose of this study was to assess the acute dermal toxicity of Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days. This study should provide a rational basis for risk assessment.
Rationale
Dermal administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item.
Five male and five female RccHan:WIST (SPF) rats were treated with Amines, bis(hydrogenated tallow alkyl) (CAS number: 61789-79-5) at 2000 mg/kg by dermal application. The test item was formulated in corn oil at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Necropsy
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
Determination and Scoring of Clinical Signs and Local Dermal Signs
Observation
Data were summarized in tabular form, showing for each individual animal the clinical and local signs at each measurement interval. All findings were described.
The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008 B.4
Data Compilation
Body weights were recorded on-line.
Mortality/viability, clinical and local dermal signs were recorded on data sheets.
Macroscopic findings were compiled into the RCC Tox Computer System during recording.
The RCC Tox Computer System (RCC-Tox-Lims) had been validated with respect to data collection, storage and retrievability. - Statistics:
- No statistical analysis was performed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 95 % CL not reported
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed during the course of the study. Well-defined erythema at the application sites was observed in all animals at day 2 (just after removal of the 24-hour application dressing) and lasted as well-defined to very slight up to
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) after single dermal administration to rats of both sexes, observed over a period of 14 days, is:
LD50 (rat): greater than 2000 mg/kg body weight
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) does not have to be classified and labelled with respect to acute dermal toxicity in the rat. - Executive summary:
Five male and five female RccHan:WIST (SPF) rats were treated with Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) at 2000 mg/kg by dermal application. The test item was formulated in corn oil at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study.
No clinical signs were observed during the course of the study.
Different local dermal signs were observed during the course of the study, including well defined to very slight erythema, scaling, scabs and fissures at the application sites. The test item did not cause any staining of the treated skin.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) after single dermal administration to rats of both sexes, observed over a period of 14 days, is: LD50 (rat): greater than 2000 mg/kg body weight Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) does not have to be classified and labelled with respect to acute dermal toxicity in the rat.
Reference
Result tables are attached to this report.
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Two acute studies are available on Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4), one on acute oral toxicity and one on acute dermal toxicity.
No LD50 value could be defined in either of the oral or dermal acute toxicity tests on Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4). The highest dose tested is therefore reported as LD50 values for these two endpoints in the Chemical Safety Assessment, since the use of "<" is not possible.
Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is a solid substance with a low vapour pressure of 2 mPa at 20°C and therefore inhalation exposure is unlikely. Data on acute inhalation is lacking, but the low potential for inhalation exposure means this is not required.
Justification for classification or non-classification
Although the acute oral study has a reliability of 2, it is considered to be correct and based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) does not have to be classified and labeled with respect to acute oral toxicity in the rat.
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) does not have to be classified and labeled with respect to acute dermal toxicity in the rat.
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