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EC number: 281-591-4 | CAS number: 83969-14-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 29 to May 22, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Acclimation period: 5 days
- Source: Winkelmann, Borchen
- Age at study initiation: 8 weeks (M), 10 weeks (F)
- Average weight at study initiation: 179 g (M), 178 g (F)
- Housing: Makrolon Cages Type III, with antidust pellet Holgranulat (FIRMASSNIFF, Soest/Westfallen)
- Diet (e.g. ad libitum): Altromin®1324 Pellets (Altromin GmbH, Lage)
- Water: drinkable water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 ± 10%
- Photoperiod: 12h / 12h (light from 6 to 18)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mg/kg bw - Doses:
- 200, 350, 500, 1000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: twice a day
- Frequency of weighing: before administration, after 1 week to the administration, at the end of observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- Spearmann & Kärber Method
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 395 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 164 - ca. 626
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 275 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 188 - ca. 738
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 177.8 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 124 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Male:
200 mg/kg bw (no animal died, 0 % mortality)
350 mg/kg bw (3 animals died after 1h from administration, 60 % mortality)
500 mg/kg bw (3 animals died from 2 to 4 h after administration, 60 % mortality)
1000 mg/kg bw (5 animals died after 1h from administration, 100 % mortality)
Female:
200 mg/kg bw (1 animal died after 2h from administration, 20 % mortality)
350 mg/kg bw (4 animals died from 1 to 4 h after administration, 80 % mortality)
500 mg/kg bw (5 animals died after 2h from administration, 100 % mortality)
1000 mg/kg bw (5 animals died after 1h from administration, 100 % mortality) - Clinical signs:
- Sedation, abdominal position, cramps, gasping
- Body weight:
- Growth not influenced
- Gross pathology:
- Negligible hystological examination
Any other information on results incl. tables
male | ||||
dose | 200 | 350 | 500 | 1000 |
vol. administered | 10 | 10 | 10 | 10 |
no. died animals | 0 | 3 | 3 | 5 |
no. of animals with symptoms | 0 | 5 | 5 | 5 |
no. used animals | 5 | 5 | 5 | 5 |
beginning of symptoms | 30' | 15' | 15' | |
end of symptoms | 1d | 1d | 1h | |
death | 1h | from 2h to 4h | 1h | |
no. of animals/intensity (1 = low, 2 = medium, 3 = high) |
||||
general condition | 3/1 | |||
sedation | 5/3 | 5/3 | 5/3 | |
abdominal position | 4/1 | 4/1 | 5/1 | |
cramps | 1/1 | |||
gasping | 4/1 | 5/1 |
female | ||||
dose | 200 | 350 | 500 | 1000 |
vol. administered | 10 | 10 | 10 | 10 |
no. died animals | 1 | 4 | 5 | 5 |
no. of animals with symptoms | 2 | 5 | 5 | 5 |
no. used animals | 5 | 5 | 5 | 5 |
beginning of symptoms | 30' | 30' | 15' | 15' |
end of symptoms | 2h | 4h | 2h | 1h |
death | 2h | from 1h to 4h | 2h | 1h |
no. of animals/intensity (1 = low, 2 = medium, 3 = high) |
||||
sedation | 2/1 | 4/3 | 5/3 | 5/3 |
abdominal position | 2/1 | 4/1 | 5/1 | 5/1 |
gasping | 2/2 | 4/1 | 5/1 | 5/1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: cat. 3, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 (male) = 395 mg/kg bw.
LD50 (female) = 275 mg/kg bw. - Executive summary:
Method
The substance was tested according to the EU method B.1. 5 rats per sex per dose have been used at concentrations of 200, 350, 500, 1000 mg/kg bw. Clinical signs and mortality were observed from 15 minute to 1 day after the administration.
Results
LD50 of the substance for male rats is 395 mg/kg bw, and for female rats is 275 mg/kg bw. Accordingly, the substance is classified in cat. 3 for acute oral toxicity according to the CLP Regulation (EC 1272/2008).
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