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EC number: 800-984-9 | CAS number: 1428547-35-6
- 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
Acute oral toxicity data exhibited a low toxicity of the substance with an LD50 > 2000 mg/kg bw. No inhalative study is available but limited exposure is expected. Assessment of dermal acute toxicity was based on a read-across with C12 -18 -(even numbered)-alkylamines indicating also a low acute toxicity (LD50 > 2000 mg/kg body weight).
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
- Study period:
- 26 December 2012 - 21 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
- 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 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: 200 g (range: 196 g to 206 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by three from the same group in polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 29 January 2013 to 20 February 2013. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Maximum dose-volume applied: 10 mL/kg
DOSAGE PREPARATION:
The test item was administered as a suspension in the vehicle. The test item was ground to a fine powder, using a mortar and pestle, and then mixed progressively with the required quantity of vehicle. The dose formulations were then kept under magnetic stirring for at least 30 minutes, in a bath water at approximately 40°C.
Fresh dose formulations were prepared by the CiToxLAB France Pharmacy on the day of each administration in brown flasks prior to administration. Dose formulations were transferred to the dosing room in a tray containing hot water (starting at approximately 40°C).The temperature of the hot water was not continuously monitored.
CLASS METHOD:
- Rationale for the selection of the starting dose: the dose-levels were selected in agreement with the Sponsor following the results of a previous oral toxicity study in rats for 14 days where the NOAEL was established at 150 mg/kg/day. No death was observed in this study in rats treated with 50, 150 and 450 mg/kg/day. Clinical signs as piloerection and hunched posture were observed on the last day of treatment in 2/4 females given 450 mg/kg/day. Lower body weight, correlating with lower food consumption, was observed throughout the treatment period in both sexes given 450 mg/kg/day.
Therefore, 2000 mg/kg/day was chosen as the starting dose-level. - Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 3 females per treatment step.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic). - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any animals.
- Gross pathology:
- There were no test item-related macroscopic findings.
The macroscopic observation correlated with common histological finding in control rats, and were thus was considered to be incidental. - Interpretation of results:
- other: not classified as toxic by oral route
- Remarks:
- Criteria used for interpretation of results: other: CLP Regulation
- Conclusions:
- The oral LD50 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item is not classified as toxic by oral route according to the criteria of CLP Regulation. - Executive summary:
The objective of this study was to evaluate the potential acute toxicity of the test item following a single oral administration (gavage) to rats.
Methods
The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil.
Based on available test item toxicity data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no toxicity was observed, the results were confirmed in other females.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on day 1 and then on day 8 or 9 and on day 15.
On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.
Results
No unscheduled deaths occurred during the study and no clinical signs were observed in any animals.
Body weight gain was unaffected by the test item treatment, when compared to CiTox LAB historical control data.
At necropsy, there were no macroscopic findings attributed to the test item administration.
Conclusion
The oral LD50of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item is not classified as toxic by oral route according to the criteria of CLP Regulation.
Reference
Sex |
|
Female |
|
Group |
CiToxLAB France Historical control data |
1 |
2 |
Dose-level (mg/kg) |
0 |
2000 |
2000 |
Body weight (mean (± SD)) |
|
|
|
. Day 1 |
208 (± 11.7) |
198 (± 2.1) |
202 (± 4.5) |
. Day 8a |
246 (± 12.7) |
231 (± 3.5) |
239 (± 1.0) |
. Day 15 |
266 (± 14.0) |
244 (± 5.1) |
259 (± 2.5) |
Body weight change (mean (± SD)) |
|
|
|
. Days 1-8b |
+39 (± 5.1) |
+33 (± 2.3) |
+38 (± 3.5) |
. Days 8-15c |
+20 (± 6.3) |
+12 (± 4.0) |
+20 (± 2.6) |
. Days 1-15 |
+58 (± 5.8) |
+45 (± 3.1) |
+58 (± 3.8) |
a: day 9 for group 2,b: days 1-9 for group 2,c: days 9-15 for group 2.
SD: standard deviations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Well performed GLP study. Result supported by another study used as read-across.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study similar to Guideline but only 4 animals (2 males/2females) per dose group used
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 4 animals per dose group used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Interfauna UK Limited, Huntingdon, Cambridgeshire, UK
- Age at study initiation: approx. 6 - 8 weeks
- Weight at study initiation: 200 - 245 g - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- The compound was administered either unchanged at a volume of 0.63 mL/kg (= 500 mg/kg) or in water at a volume of 5 mL/kg (=2000 mg/kg).
Since the compound is described as corrosive and dermal irritative reactions were noted in the 500 mg/kg group (undiluted test material), dilution
for testing of the acute dermal toxicity at 2000 mg/kg bw is justifiable.
TEST SITE
- Area of exposure: 10% of total body surface
- % coverage: 100
- Type of wrap if used: occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.63 ml/kg (undiluted, 500 mg/kg group); 5 ml/kg (40% solution, 2000 mg/kg group)
- Concentration (if solution): 40% in water (only for 2000 mg/kg dose group)
VEHICLE
- water (only for 2000 mg/kg dose group) - Duration of exposure:
- 24h
- Doses:
- 500 mg/kg bw (undiluted)
2000 mg/kg bw (diluted to 40% w/v in water) - No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: 500 mg/kg/bw: no clinical signs throughout observation period 2000 mg/kg/bw: hunched posture, abnormal gait (waddling), lethargy, and decreased respiratory rate (shortly after treatment, free of symptoms thereafter)
- Gross pathology:
- Terminal autopsy revealed slight bruising in the subcutaneous tissue of one male and one female rat dosed at 500 mg/kg bw and scab formation with or without ulceration was seen in all rats dosed at 2000 mg/kg bw.
An area of minimal congestion of the stomach (mucosal aspect) was seen in one female rat dosed at 2000 mg/kg bw. - Other findings:
- Dermal reactions:
necrosis in all rats dosed at 500 mg/kg bw, persisting until day 12
well defined to moderate oedema in rats dosed at both levels - Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose (LD 50) of Amine KK to rats was greater than 2000 mg/kg body weight
- Executive summary:
In a GLP-compliant study similar to OECD TG 402, the test compound Amine KK (cocoalkylamine), a yellow liquid (purity 100%), was dermally applied under occlusion to Sprague-Dawley rats. At a dose level of 500 mg/kg body weight, the test material was applied undiluted (application volume 0.63 ml/kg bw), at a dose level of 2000 mg/kg bw the substance was diluted to a 40% solution (w/v) in distilled water (application volume 5 ml/kg). Compared to a regular OECD TG 402 study a reduced number of animals was used (4 instead of 5 animals/dose). There were no mortalities, hence, the LD50 is > 2000 mg/kg bw. No clinical signs were observed at 500 mg/kg bw. At 2000 mg/kg, hunched posture, abnormal gait, lethargy and decreased respiratory rate were noted. Signs of dermal reactions at the application site of both treatments were well defined to moderate oedema until days 4-5. Hard scabs, persisting to the end of the observation period, frequently prevented the assessment of oedema.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Read across with a GLP study.
Additional information
Oral
The toxic effects following an acute oral dose of the registered substance was determined according to the guidelines for the acute toxic class method (OECD 423) performed under GLP.
In step 1 three female rats were dosed by oral gavage with 2000 mg/kg body weight in corn oil. As no signs of toxicity were observed during the first 5 days in any animals, three additional female rats were dosed also with 2000 mg/kg body weight in step 2. No compound related mortality or clinical signs were again observed. According to the toxic class regime no further testing was required. The LD50 therefore was > 2000 mg/kg bw .
Studies for the oral route are also available for hydrogenated tallow alkylamines as well as for all other category members of primary alkylamines. For hydrogenated tallow alkylamines a LD50 of greater 5000 mg/kg body weight was established. Comparable LD50 values indicating moderate acute oral toxicity were revealed also for tallow alkylamines and octodecenylamines. This view of only moderate toxicity was also taken in the existing EU risk assessment of primary alkylamines.
Inhalation:
There is no study on inhalation toxicity available for the registered substance.
REACH stipulates that testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. REACH guidance R.7.a, chapter. 7.4 Acute toxicity, indicates that in principle no inhalation studies are needed when vp < 0.1 Pa at 20°C or particle size > 100 µm. The registered substance is a solid (scales) with no expected inhalable particles and a vapour pressure around 0.0079 Pa at 20°C (value based on read-across from oleylamine). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur, and no acute inhalation test was performed. In addition, considering the apparently low systemic toxicity of the primary alkylamines, no need for further inhalative testing was seen.
There is no risk for aspiration as with a mp of 77°C, the registered substance is a solid upon ingestion.
Dermal:
There is no dermal LD 50 value for acute skin toxicity of the registered substance. Acute toxicity by oral route resulted to a LD50 cut-off value of 2500 mg/kgbw indicating relative low acute systemic toxicity for which no classification is required. Considering the apparently low systemic toxicity of the primary alkylamines, no need for further dermal testing was seen. In addition, a read-across can be made with C12 -18 -(even numbered)-alkylamines for which a dermal acute toxicity study performed in rat is available and demonstrated also a low acute toxicity (LD50 > 2000 mg/kg body weight).
Justification for classification or non-classification
No classification for acute toxicity required:
Low systemic toxicity is indicated by Oral LD50 > 2000 mg/kg bw.
Dermal systemic toxicity is expected to be similarly low based on a read across approach with primary alkylamines.
Related to low vp and no inhalable particles, there will be no exposures via inhalation.
No classification STOT-SE Cat.3 needed:
The active substance is not structurally related to any known class of neurotoxic chemicals. In addition, repeated dose studies with the substance or primary alkylamines did not show indications of specific neurotoxicity, in specific neurotoxicity measures as sensory activity, grip strength, and motor activity assessment.
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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