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EC number: 236-882-0 | CAS number: 13531-52-7
- 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
Oral LD50 (rat) = 654 mg/kg b.w. (BASF 1977, similar to OECD 401)
Dermal LD50 (rabbit) = 184 mg/kg b.w. (BASF 1977, similar to OECD 402)
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:
- 1976 - 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Method: BASF-Test, see details in the section "Any other information on materials and methods incl. tables".
- GLP compliance:
- no
- Remarks:
- study was performed prior to GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 196 g (mean); female: 166 g (mean) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.64 % - 46.4 % in aqua. dest - Doses:
- 4640, 1470, 1000, 681, 464 µL/kg bw (corresponding to 426.9, 626.5, 920.0, 1352.4 and 4268.8 mg/kg bw, calculated assuming test substance density of 0.92 g/mL)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Not indicated.
- Preliminary study:
- Probit analysis
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 654 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated from 0.7 mL/kg assuming a test substance density of 0.92 g/mL
- Mortality:
- All animals of the lowest dose group (426.9 mg/kg bw) survived (males: 0/5; females: 0/5). In the following dose group (626.5 mg/kg bw) no male animals died (0/5), but female animals (4/5). In higher dose groups (920.0 and 1352.4 mg/kg bw) mortality was also observed (males: 4/5 and 5/5; females: 4/5 and 4/5). No animals survived in the highest dose group (4268.8 mg/kg bw).
- Clinical signs:
- other: Dyspnea, apathy, abdominal position, lateral position, stagger, atonia, tremor, reduced general condition, diarrhoe, spasctic gait as well as initial body weight loss partially or in some animals of all but the low dose group
- Gross pathology:
- Heart dilation, congestive hyperemia in the heart , atonic and dilated stomach, diffuse erythema in the gastro-oesophageal vestibule, as well as dilated gut with bloody diarrhea were observed partially or in all animals of all but the low dose group.
Reference
Mortality
Dose (µl/kg) | Conc. (%) | male animals | femal animals |
4640 | 46.4 | 5/5 | 5/5 |
1470 | 14.7 | 5/5 | 4/5 |
1000 | 10 | 4/5 | 4/5 |
681 | 6.81 | 0/5 | 4/5 |
464 | 4.64 | 0/5 | 0/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 654 mg/kg bw
- Quality of whole database:
- Estimated Klimisch Rating: 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976 - 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: according to H.F. Smyth et al.: Am. Ind. Hyg. Ass. J. 23, 95-107, (1962)
- GLP compliance:
- no
- Remarks:
- study was performed prior to GLP
- Test type:
- other: Inhalation hazard test
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 226 g (mean) - Route of administration:
- inhalation: vapour
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature in air chamber: 20°C
- Saturated vapour
- Duration of exposure:
- 8 h
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 1 days
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: attempt to escape, closure eyelid, eye irritation
- Body weight:
- No adverse effects observed.
- Gross pathology:
- Nothing abnormal detected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Estimated Klimisch Rating: 2
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:
- 1976 - 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only one dose level
- GLP compliance:
- no
- Remarks:
- study was performed prior to GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 3.29 kg (mean); female: 3.44 kg (mean)
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 cm²
TEST MATERIAL
- Concentration: 100 %
- Duration of exposure:
- once
- Doses:
- 200 µL/kg equivalent to 184 mg/kg bw
- No. of animals per sex per dose:
- 3
- 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 - Statistics:
- None
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 184 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated from 0.2 mL/kg assuming a test substance density of 0.92 g/mL
- Mortality:
- 2 male animals and 1 female animal died after 7 days.
- Clinical signs:
- other: slight apathy in all animals, apathy in 3 animals, urine tinged with blood in 3 of the 3 animals that died
- Gross pathology:
- - Animals that died spontaneously: Kidney (renal pelvis and urinary bladder filled with blood); Liver (focal mass necroses); lung (severe edema); heart (dilatation bilaterally)
- Animals sacrificed after 14 days: no adverse effects observed - Other findings:
- Necrosis was observed in all animals
Reference
Mortality
Dose (µl/kg) | Conc. (%) | No. of Animals | died within1 h | 24 h | 48 h | 7 d | 14 d |
200 | 100 | 3 male | 0/3 | 0/3 | 0/3 | 2/3 | 2/3 |
200 | 100 | 3 female | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 184 mg/kg bw
- Quality of whole database:
- Estimated Klimisch Rating: 2
Additional information
Acute toxicity: oral
The acute oral toxicity of the test substance in the rat was examined in an in-house study following the principles of OECD TG 401 (BASF AG, 1977). Sprague Dawley rats were given a single oral dose of N3-amine (4640, 1470, 1000, 681, 464 µL/kg bw (corresponding to 426.9, 626.5, 920.0, 1352.4 and 4268.8 mg/kg bw, calculated assuming test substance density of 0.92 g/mL)). Animals were then observed for mortality and for clinical symptoms of toxicity for 14 days. All animals were subjected to necropsy. The oral LD50 was estimated as 654 mg/kg bw. This acute oral toxicity study is classified as acceptable.
Acute toxicity: inhalation (inhalation hazard test, BASF AG, 1977)
In an acute inhalation toxicity study according to H.F. Smyth et al. (Am. Ind. Hyg. Ass. J. 23, 95-107, 1962) male and female rats were exposed to N3-amine saturated vapour for a period of 8 hours and observed for 1 day. All animals were subjected to necropsy. Closure eye lid and eye irritation were observed. No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that has been saturated at 20 degrees centigrade with the volatile part of the compound.
Acute toxicity: dermal
The acute dermal toxicity of the test substance was examined in an in-house study following in principle of OECD TG 402, only one dose level was tested (BASF AG, 1977). Vienna White rabbits (3 m/f) were dermally exposed to unaltered N3-amine at a dosage of 200 µL/kg. Animals were then observed for mortality and for clinical symptoms of toxicity for 14 days. Two male animals and 1 female animal died after 7 days. All animals were subjected to necropsy.As clinical signs slight apathy in all animals, apathy in 3 animals, and urine tinged with blood in 3 of the 3 animals that died were observed. The oral LD50 was estimated as 184 mg/kg bw (calculated from 0.2 mL/kg assuming a test substance density of 0.92 g/mL). This acute dermal toxicity study is classified as acceptable.
In a supporting study (TCSAT, 1992) performed with rabbits, a LD50 of approximately 126 mg/kg bw was observed. The test substance was readily absorbed through skin in toxic amounts.
Further study (i.p. route)
The test substance was applied i.p. in mice (BASF AG, 1977). A LD50 value of 158 mg/kg bw was estimated, corresponding to 170 µL test substance/kg. Intraabdominal adherence was observed in gross pathology.
Justification for selection of acute toxicity – oral endpoint
Reliable study classified as key study. Only one study available.
Justification for selection of acute toxicity – dermal endpoint
Reliable study classified as key study.
Justification for classification or non-classification
Based on the results for acute oral (LD50 rat = 654 mg/kg bw), acute dermal (LD50 rabbit = 154 mg/kg bw) and inhalation toxicity (no mortality) the test substance is classified as follows:
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under EU Regulation 1272/2008 (CLP). As a result the substance is considered to be classified for acute oral and dermal toxicity as follows:
acute toxicity: cat. 4, (H302, harmful if swallowed), cat. 2, (H310, fatal in contact with skin).
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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