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- 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
data on acute oral and dermal toxicity are available for the components.
Amine: LD50 oral > 2000 mg/kg bw (BASF 1993); LD50 dermal 8000 mg/kg bw (UC1973)
Acid: LD50 oral 775 mg/kg bw (SPL1988); LD50 dermal >2000 mg/kg bw (Sodium salt of acid 1986)
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
- Remarks:
- the tested substance is the acid part of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Safepharm Standard Test Method Number 513.01
- Principles of method if other than guideline:
- A group of three fasted males and three fasted females were treated with the starting dose (2000 mg/kg bw). As the females dosed with 2000 mg/kg bw died, a further three fasted males and three fasted females were treated with the dose level 300 mg/kg bw. The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14 or at death. At the end of the observation period the surviving animals were killed by cervical dislocation and all animals were subject to gross necropsy.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days.
- Doses:
- 300,2000
- No. of animals per sex per dose:
- 9
- Control animals:
- yes
- Details on study design:
- A group of three fasted males and three fasted females were treated with the starting dose (2000 mg/kg bw). As the females dosed with 2000 mg/kg bw died, a further three fasted males and three fasted females were treated with the dose level 300 mg/kg bw. The test material was administered orally as a solution in distilled water. The animals were observed 1/2, 1, 2, and 4 hours after dosing and then once daily for up to 14 days. Bodyweights were recorded on Day 0 (day of dosing) and on Days 7 and 14 or at death. At the end of the observation period the surviving animals were killed by cervical dislocation and all animals were subject to gross necropsy
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 775 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 value is geometric mean between 300 and 2000 mg/kg bw.
- Mortality:
- Three females were found dead one day after dosing at the 2000 mg/kg bw dose level. There were no deaths at the 300 mg/kg bw dose level.
- Clinical signs:
- No clinical signs of toxicity were noted in animals treated with 300 mg/kg bw.
- Body weight:
- The surviving animals showed expected gains in body weight over the study period.
- Gross pathology:
- Abnormalities noted at necropsy of animals that died duringthe study were abnormally red lungs, dark liver, and dark kidneys.
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute oral LD50 in male/female rats is 775 mg/kg bw. LD50 value is geometric mean between 300 and 2000 mg/kg.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Remarks:
- the tested substance is the amine part of the compound
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 401), GLP compliant
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- 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 ANIMALS- Source: DR. K. THOMAE GMBH- Age at study initiation: young adult animals- Weight at study initiation: 150 - 300 g- Fasting period before study: 16 h before administration- Housing: single housing- Diet: Kliba-Labordiaet 343, Klingenthalmuehle AG, CH-4303 Kaiseraugust, ad libitum- Water: tap water ad libitum- Acclimation period: at least 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24°C- Humidity (%): 30-70 %- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE- Justification for choice of vehicle: The test substance is insoluble in aqua bidest- Concentration in vehicle: 20 or 40 g/100 ml for the 1000 or 2000 mg/kg bw dose, respectively - Amount of vehicle: 5 ml/kg bw
- Doses:
- 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations: Twice each workday and once on weekends- Frequency of weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight
- Statistics:
- No statistics needed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured.
- Clinical signs:
- No symptoms were observed.
- Body weight:
- The expected body weight gain has been observed in the course of the study.
- Gross pathology:
- No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
Referenceopen allclose all
Mean body weights.
male | female | ||||
Dose | 1000 mg/kg | 2000 mg/kg | 1000 mg/kg | 2000 mg/kg | |
day 0 (before application) | 181 | 200 | 189 | 188 | |
day 7 | 248 | 264 | 220 | 215 | |
day 12 | 273 | - | 224 | - | |
day 13 | - | 301 | - | 226 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 775 mg/kg bw
- Quality of whole database:
- data from representatives of both parts of the salt are used in a worst case approach
Acute toxicity: via inhalation route
Endpoint conclusion
- Quality of whole database:
- no reliable studies available, waiver based on exposure considerations
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: the tested substance is the acid part of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CFY (remote Sprague Dawley origin)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were in a weight range of 210 to 239 g prior to dosing on day 1 and approximately six to eight weeks of age. All the rats were acclimated to the experimental environment for a period of 15 days prior to study initiation. Animals were housed in individual metal cages with wire mesh floors. Standard diet and water were provided ad libitum. Each animal was identified by cage number and ear punching.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Test material was a yellow viscous liquid and was applied to an area clipped with electric clippers (approximately 10% of the area) on the backs of 10 rats (five male, five female) at a dose of 2000 mg/kg. The areas were covered with gauze held in place with an impermeable plastic dressing. At the end of 24 hours the dressings were carefully removed and the treated area of skin washed in warm water and blotted dry with absorbent paper.
- Duration of exposure:
- 24 hr
- Doses:
- 2000 mg/kg (undiluted)
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not specified
- Details on study design:
- Animals were observed soon after dosing and 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. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. All animals were observed for 14 days after dosing. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: undiluted
- Mortality:
- No mortality was observed exposure to 2000 mg/kg of the undiluted test material.
- Clinical signs:
- There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings. These reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination.
- Body weight:
- Low bodyweight gains or loss of bodyweight were recorded for one male and three female rats on day 8. Two of the same females and a third female rat also showed low bodyweight gains between days 8 and 15.
- Gross pathology:
- All terminal autopsy findings were normal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose was found to be greater than 2000 mg/kg.
- Executive summary:
The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: the tested substance is the amine part of the compound
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not conducted according to guidelines or GLP but the report contains sufficient data for interpretation of study results.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- 24 hr dosing period followed by a 14 hour observation period
- GLP compliance:
- no
- Test type:
- other: 24 hr dermal dosing period followed by a 14 our observation period
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Albino rabbits, 3 to 5 months of age.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Male albino rabbits, 3 to 5 months of age, are immobilized during the 24-hour contact period with the compound retained unter impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid is removed to prevent ingestion.
- Duration of exposure:
- 24-hours
- Doses:
- 16000, 8000 or 4000 mg/kg
- No. of animals per sex per dose:
- 4 male rabbits/dose level
- Control animals:
- not specified
- Details on study design:
- Non-fasted animals are maintained on appropriate Rockland diets and water ad lib except during period of manipulation or confinement. Dosage intervals differ by a factor of 2 in a geometric series.
- Statistics:
- LD50 was calculated by the moving average method based on a 14-day observation period.
- Preliminary study:
- not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 8 000 mg/kg bw
- Mortality:
- Rabbits given 16000, 8000 or 4000 mg/kg resulted in 4/4, 2/4 and 0/4 (dead/dosed),
- Clinical signs:
- Skin irritation consisting of erythema and necrosis where pressure of stocks was present, was observed at all dose levels.
- Body weight:
- 8000 mg/kg in survivors:one rabbit gained 318 g while other rabbit lost 143 g over 14 day observation period4000 mg/kg:all rabbits gained weight during 14 day observation period. Weight gain ranged from 140 to 313 g.
- Gross pathology:
- Gross pathology consisted of congestion of lungs, livers, spleens and kidneys, mottled livers and opaque stomachs.
- Other findings:
- no data
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test substance was slightly toxic following acute, covered dermal application
- Executive summary:
The amine was applied dermally for 24 hours at doses of 4000, 8000 or 16,000 mg/kg to the intact skin of groups of 4 male rabbits. All rabbits from the 16,000 mg/kg group died while 2 of 4 rabbits from the 8000 mg/kg group died within the 14-day observation period. The dermal LD50 was determined to be 8000 mg/kg using the moving average method of statistical analysis.
Referenceopen allclose all
There were no deaths or signs of a systemic reaction following a single dermal application at 2000 mg/kg bw. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressing on Day 2. All test sites were entirely covered by scab formation from Day 7. Sloughing from the scabbed skin began at various timesbetween Day 7 and Day 12 and was completed before termination. Lowbodyweight gains or loss of body weight were recorded for one male andthree females in Day 8. Two of the same females and a third female alsoshowed low bodyweight gain between Days 8 and 15.
Rabbits given 16000, 8000 or 4000 mg/kg resulted in 4/4, 2/4 and 0/4 (dead/dosed), respectively. Skin irritation consisting of erythema and necrosis where pressure of stocks was present, was observed at all dose levels. Gross pathology consisted of congestion of lungs, livers, spleens and kidneys, mottled livers and opaque stomachs.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- data from representatives of both parts of the salt are used in a worst case approach
Additional information
The acute toxicity testing with the amine and the acid shows that the amine is of lower toxicity than the acid. Therefore in a worst case approach the toxicity data from acid are used to assess the toxicity of the salt.
Justification for classification or non-classification
For oral toxicity the substance needs to be classified in accordance with Regulation (EC) No 1272/2008 (CLP) as acute toxic cat 3 (H302). No classification is necessary for dermal toxicity based on the outcome of the studies.
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