Registration Dossier
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EC number: 201-164-8 | CAS number: 78-98-8
- 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
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-01 to 1987-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD), non-GLP but internally audited.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report Date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: not specified
- Weight at study initiation: "comparable" (+/- 20% of the mean weight)
- Fasting period before study: 16 h
- Housing: Stainless steel wire mesh cage (Type DK III)
- Diet: ad libitum (except during fasting)
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 1987-04-01 to 1987-05-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50, 31.6, 21.5, 10, 4.64 mg / mL (w/v)
- Amount of vehicle: 0.5% CMC in water
- Justification for choice of vehicle: "Aqueous formulation corresponds to the physiological medium"
MAXIMUM DOSE VOLUME APPLIED: 10 mL / kg bw - Doses:
- 1500, 948, 645, 300, 139 mg/kg bw, calculated (30%) from original dosages:
5000, 3160, 2150, 1000, 464 mg/kg bw - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
a) signs and syptoms: several times on the day of application, at least once daily on workdays thereafter;
b) moribund or dead animals: twice daily on workdays and once daily on public holidays
- Frequency of weighing: Once at beginning of test, d6 or d7, d13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 380 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: interpolated (from 30% solution)
- Mortality:
- 5000 mg/kg bw: males: 2 within one day; females: 5 within one day
3160, 2150, 1000 and 464 mg/kg bw: no mortality - Clinical signs:
- Dyspnea, apathy, abnormal position, staggering, atonia, paresis, piloerection, cyanosis, poor general state
- Body weight:
- Mean weight males:
5000 mg/kg bw:: 192 (d0); 250 (d7); 291 (d13)
3160 mg/kg bw:: 190 (d0); 246 (d6); 283 (d13)
2150 mg/kg bw:: 188 (d0); 253 (d7); 283 (d13)
1000 mg/kg bw:: 189 (d0); 270 (d7); 302 (d13)
464 mg/kg bw:: 181 (d0); 258 (d7); 286 (d13)
Mean weight females:
5000 mg/kg bw:: 172 (d0)
3160 mg/kg bw:: 180 (d0); 205 (d6); 217 (d13)
2150 mg/kg bw:: 189 (d0); 223 (d7); 232 (d13)
1000 mg/kg bw:: 182 (d0); 216 (d7); 222 (d13)
464 mg/kg bw:: 180 (d0); 214 (d7); 223 (d13) - Gross pathology:
- Perished males and females: General congestion. Stomach: mucosa of glandular stomach reddened, partly white
Sacrificed males and females: no pathologic findings - Other findings:
- No
Applicant's summary and conclusion
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