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Diss Factsheets
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EC number: 931-228-7 | CAS number: -
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The LD50 for oral toxicity is 1300 mg/kg bw (RL2, rat).
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:
- other: Study based on national and scientific standards, basic data given, acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 - 120 g
- Fasting period before study: overnight - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw
- Doses:
- 0, 1.0, 1.6, 2.5, and 4 mL/kg bw (~800, 1300, 2000, and 3200 mg/kg bw)
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculation of the LD50 and 95% C.I. based on Litchfield and Wilcoxon, J. Pharmac. Exp. Ther., 96, 99-113 (1949)
- Preliminary study:
- Preliminary range finding study was conducted on 2 animals per dose group (one male and one female) at 0, 1.0, and 4.0 mL/kg bw. Only in the highest dose group mortality was observed in both rats < 21 hourse after dosing.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1.6 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.1 - <= 2.2
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 880 - ca. 1 760
- Remarks on result:
- other: Estimates using a density of 0.8 g/mL
- Mortality:
- Death occurred from within 21 to 70 h of treatment. Autopsy revelaed darkenning of the liver and kidneys and injection of mesenteric blood vessels.
- Clinical signs:
- other: Shortly after dosing: lethargy, piloeerection, diuresis, diarrhea, increased salivation, and fine body tremor; later on: additionally ataxia at 1.6 and 2.5 mL/kg bw and lacrimation at 2.5 mg/kg bw.
- Gross pathology:
- Darkening of livers and kidney and injection of mesenteric blood vessels.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the experimental data an oral LD50 of 1.6 mL/kg bw was calculated for males and females resulting in an LD50 of around 1300 mg/kg bw.
- Executive summary:
The acute toxicity of the test item was investigated (n= 3 males and females per dose group). Rats received single undiluted oral doses of the test item by oral intubation and were observed for 14 days thereafter. Clinical signs like lethargy, piloeerection, diuresis, diarrhea, increased salivation, and fine body tremor were observed shortly after dosing. These signs were later accompanied by ataxia at 1.6 and 2.5 mL/kg bw and by increased lacrimation at 2.5 mg/kg bw.
Death occured from within 21 to 70 hours of treatment. Autopsy revealed darkening of the liver and kidneys and injection of mesenteric blood vessels.
Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within five days of treatment. Slightly depressed bodyweight gains were observed during the first week of observation, but returned to normal during the second week, compared with controls.
Terminal autopsy findings were normal.
Based on the experimental data an oral LD50 of 1.6 mL/kg bw was calculated for males and females resulting in an LD50 of around 1300 mg/kg bw.
Reference
Summary of Mortality Data (from Report, Tab. 2)
Dose [mL/kg bw] |
Male rats |
Female rats |
Total |
Absolute number of deaths |
|||
0 |
0/3 |
0/3 |
0/6 |
1.0 |
0/3 |
1/3 |
1/6 |
1.6 |
2/3 |
1/3 |
3/6 |
2.5 |
3/3 |
3/3 |
6/6 |
4.0 |
3/3 |
3/3 |
6/6 |
Time of death after dosing:
Men:
1.6 mg/kg: < 70 h
2.5 mg/kg; < 46 h
4.0 mg/kw: < 22 h
Women:
1.0 mg/kg: < 46 h
1.6 mg/kg: < 22 h
2.5 mg/kg; < 51 h
4.0 mg/kw: < 22 h
Evaluation of Bodyweight after dosing in g
Sex | Dosage in mL/kg | Bodyweight at Dosing in g | Bodyweight after 1 week in g | Bodyweight after 2 weeks in g |
male |
0 |
107 |
185 |
231 |
1.0 |
113 |
153 |
209 |
|
1.6 |
112 |
152 |
210 |
|
2.5 |
111 |
Died |
- |
|
4.0 |
111 |
Died |
- |
|
femal |
0 |
106 |
162 |
185 |
1.0 |
111 |
139 |
174 |
|
1.6 |
112 |
136 |
167 |
|
2.5 |
115 |
Died |
- |
|
4.0 |
110 |
Died |
- |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 300 mg/kg bw
Additional information
In one experimental study male CFY rats (3 rats/sex/dose) were subjected to test acute oral toxicity. The test item (purity not mentioned) was administered by gavage to animals in 4 different dose levels and were observed for further 14 days. The results obtained led to a LD50 = 1300 mg/kg bw (Kynoch et al., 1975). This reliable study was selected as key study.
Another reliable experimental study performed (RL 1; according to OECD 401, limit dose test) in rats result in a slightly higher LD50 of > 2000 mg/kg bw (Jensch, 1997). Here the oral toxicity of the test item was tested only at a dose level of 2000 mg/kg bw. The animals received the compound as a 20 % solution in sesame oil, the administration volume being 10 mL/kg bw.
Justification for classification or non-classification
Based on the requirements of Regulation (EC) No 1272/2008 and an oral LD50 of 1300 mg/kg bw in experimental animals C13/C15 amine should be classified as acutely oral toxic category IV, H302.
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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