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EC number: 929-207-2 | CAS number: 1172126-47-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 19 - February 9, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: Single oral (gavage) dose
- Limit test:
- no
Test material
- Reference substance name:
- sodium 2-(dimethylamino)-1-hydroxyethane-1-sulfonate
- EC Number:
- 929-207-2
- Cas Number:
- 1172126-47-4
- Molecular formula:
- C4 H11 Cl N Na O4 S
- IUPAC Name:
- sodium 2-(dimethylamino)-1-hydroxyethane-1-sulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
Species, number of animals: 9 rats, 3 males (M) and 6 females (F)
Strain: Crl:WI(Han), SPF quality
Supplier: Charles River Laboratories, Sulzfeld, Germany
Age (Day 1): approximately 8 weeks
Body weight range (Day 1): males 231-236 g, females 165-167 g
HOUSING CONDITIONS:
Housing and target ranges of the climate conditions were as follows:
Room number: 35, building N81
Temperature: 22 ± 2°C
Relative humidity: 45%-75%
Light/darkness cycle: 12/12 hours
Illumination period: 06:00 h-18:00 h
Average illumination: approximately 60 lx (depending on the cage position; during
work in the room the intensity is raised to approximately
450 lx)
Air change: minimum of 10 air changes per hour
FOOD & DRINKING WATER:
The animals were offered pelleted dry food (Kliba No. 3438.0.25, Provimi Kliba SA,
Kaiseraugst, Switzerland). The lot number of the food is recorded in the raw data. The food is
analyzed regularly for major nutritive components and significant contaminants by the
manufacturer. It was available ad libitum, but was withdrawn in the afternoon of Day -1 (at
about 16:00 h) over night. Immediately post administration, free access to food was allowed
again.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX)
- Details on oral exposure:
- PD 159 NA was suspended in 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX) and
administered by oral gavage (20 mL/kg) at single doses of 200 mg/kg (females only) and
2000 mg/kg (males and females), respectively, to groups of Crl:WI(Han) rats, which were
about 8 weeks old. - Doses:
- 200 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females per 200 mg/kg bw
3 males per 2000 mg/kg bw
3 females per 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- Prior to administration, the rats were kept over night without food, but with free access to
drinking water. Free access to food was allowed again immediately subsequent to
administration.
In the morning of the day, single oral administration of PD 159 NA suspended in Natrosol® 250 HX was performed by gavage per group.
The administration volume was 20 mL/kg in each group.
group 1: 3 females per 200 mg/kg bw
group 2: 3 males per 2000 mg/kg bw
group 3: 3 females per 2000 mg/kg bw
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats subsequent to a single oral administration of 200 mg/kg
and 2000 mg/kg, respectively. - Clinical signs:
- other: 200 mg/kg (females) Throughout the entire observation period, no clinical signs were noted in any rat. 2000 mg/kg (males and females) During the entire observation period, no clinical signs were noted in males. In females, piloerection was the only clinic
- Gross pathology:
- At necropsy, no findings were noted in females subsequent to administration of 200 mg/kg or
in male and female rats administered 2000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- Under the conditions of the present study, no mortality was seen in rats subsequent to oral
administration of PD 159 NA at doses of 200 mg/kg and 2000 mg/kg, respectively.
Thus, the approximate lethal dose (ALD) for PD 159 NA, an intermediate of
BIBW 2992 MA2, is above 2000 mg/kg.
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