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EC number: 445-790-1 | CAS number: 404362-22-7
- 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
In an acute oral toxicity test, the LD50 was in the range between 500 and 2000 mg/kg. As the submission item turned out to be corrosive, no further acute testing was performed.
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:
- from 2002-01-29 to 2002-02-14 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study without deviations, not performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crj: CD(SD)IGS, SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Co., Ltd.
- Age at study initiation: 5 weeks
- Weight at study initiation: 113 ± 2.5 g (males), 97.0 ± 3.4 g (females)
- Fasting period before study: Rats were fasted overnight. Feeding was restarted three to four hours after dosing.
- Housing: in groups of six to ten in suspended metal wire cages on a rat cage rack equipped with a feed water supply system (Tokiwa Scientific Instrument Co., Ltd.)
- Diet (e.g. ad libitum): free access to a rat pellet diet MF (Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): free access to mains water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 6
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: from 2002-01-29 to 2002-02-14 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.25, 0.5, 2, 5 and 20 (w/v)% olive oil solutions
- Amount of vehicle (if gavage): 1.0 mL per 100 g body weight
- Justification for choice of vehicle: not reported
MAXIMUM DOSE VOLUME APPLIED: 1.0 mL per 100 g body weight
DOSAGE PREPARATION (if unusual): A prescribed amount of test material was weighed out and diluted with olive oil in order to formulate 0.25 to 20 (w/v)% olive oil solutions as test solutions. - Doses:
- 25, 50, 200, 500 and 2000 mg/kg
- No. of animals per sex per dose:
- 6 animals per sex and dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed daily for mortality and clinical signs, weighed immediately before dosing and on Days 2, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: This value is calculated as the geometric mean of the highest test dose without mortalities (500 mg/kg) and the first one with mortality in all test animals.
- Mortality:
- Male: 25 mg/kg bw; Number of animals: 6; Number of deaths: 0
Male: 50 mg/kg bw; Number of animals: 6; Number of deaths: 0
Male: 200 mg/kg bw; Number of animals: 6; Number of deaths: 0
Male: 500 mg/kg bw; Number of animals: 6; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 6
Female: 25 mg/kg bw; Number of animals: 6; Number of deaths: 0
Female: 50 mg/kg bw; Number of animals: 6; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 6; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 6; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 6 - Clinical signs:
- other: Males from the 25, 50 and 200 mg/kg dose groups showed no abnormalities. In the 500 mg/kg dose group, all of the six males showed body descent, but five of them recovered two hours after treatment. One animal from the dose group showed body descent and ab
- Gross pathology:
- The decreased six males and six females from the 2000 mg/kg
dose group showed mucosal bleeding in glandular stomach,
intestinal tract, and anterior stomach, white anterior
stomach mucous membrane, and intestinal tract mucosal
colliquation.
No abnormalities were noted in males and females from the 25, 50, 200 and 500 mg/kg dose groups that survived the test period. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test material was in the range between 500 and 2000 mg/kg.
- Executive summary:
An acute oral toxicity test of the reaction product of 1,1'-(benzene-1,3 -diyl)bis(methylamine) and styrene was conducted in compliance with the OECD Test Guidelines No. 401 (1987) in the rat.
The reaction product was orally administered by gavage to SD rats (SPF). The tested concentrations lay in the range of 25 to 2000 mg/kg bw and 6 male and 6 female rats were treated per concentration. No abnormalities were detected in animals treated with 200 mg/kg bw or less. Animals treated with 500 mg/kg bw showed clinical signs (body descent, abnormal gait (male), squatting (female), diarrhea, loss of fur), but no abnormalities were observed on Day 3 or later. All animals treated with 2000 mg/kg bw died within 5 hours after application.
The LD50 of the test material was determined to be in the range of 500 and 2000 mg/kg. Accordingly, the reaction product falls into acute toxicity hazard category 4 according to Regulation (EC) No 1272/2008 (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Klimisch 2, OECD guideline-conform, non GLP.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An acute oral toxicity test was conducted in compliance with OECD TG No. 401. The submission item was orally administered by gavage to male and female rats. The acute oral LD50 of the test material was in the range between 500 and 2000 mg/kg bw.
As the submission item turned out to be corrosive, neither the dermal nor the inhalative route of application was tested in an acute toxicity test in accordance with Regulation (EC) 1907/2006, column 2 of Annex VIII.
Justification for selection of acute toxicity – oral endpoint
Valid study, only available data source for acute oral toxicity. The LD50 of the test material was in the range between 500 and 2000 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
The test item is corrosive to the skin. Therefore, no study on acute inhalation toxicity needs to be conducted in accordance with Regulation (EC) 1907/2006, column 2 of Annex VIII.
Justification for selection of acute toxicity – dermal endpoint
The test item is corrosive to the skin. Therefore, no study on acute dermal toxicity needs to be conducted in accordance with Regulation (EC) 1907/2006, column 2 of Annex VIII.
Justification for classification or non-classification
The acute oral LD50 was determined to be in the range of 500 and 2000 mg/kg in an acute oral toxicity test.
Regulation (EC) No 1272/2008 (CLP): Acute oral toxicity hazard category 4, H302 "Harmful if swallowed".
Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC): Xn; R22 "Harmful if swallowed".
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