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EC number: 700-934-5 | CAS number: -
- 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:
- November 05 to November 27 (experimental period)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- EC Number:
- 700-934-5
- Molecular formula:
- No exact molecular formula can be given for a complex reaction mixture (UVCB substance).
- IUPAC Name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- Details on test material:
- - Name of test material (as cited in study report): TPI 1618
- Substance type: Formaldehyde releaser
- Physical state: Colourless liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: ethylene glycol, urea, paraformaldehyde
- Purity test date: 25. October 2007
- Lot/batch No.: 1118965
- Expiration date of the lot/batch: December 2008
- Stability under test conditions: freshly prepared shortly prior to administartion
- Storage condition of test material: dry, room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld
- Age at study initiation: not detailed
- Weight at study initiation: 142-172g (on day of dosing)
- Fasting period before study: overnight
- Housing: In macrolon cages, 2 or 3 animals per cage
- Diet : ad libitum
- Water : e.g. ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod: 12 hrs dark /12 hrs light):
IN-LIFE DATES (DOSING): Sighting study: November 6th, 2007; Main study: November 14, 2007
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 80%
- Justification for choice of vehicle: Soluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Fixed dose method, started with 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female used for sighting study
4 females used for main experiment - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight recording: day 0 (test start), day 7 day 14 ; Clinical signs: each rat was observed 30 min., 2, 4 and 6 hours post-dosing and daily thereafter over a period of 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No preterminal deaths. Therefore no statistical proceduresecessary
Results and discussion
- Preliminary study:
- 1 female was dosed at 2000 mg/kg bw.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no preterminal deaths. Therefore no CL determined
- Mortality:
- No animal died
- Clinical signs:
- other: Hunched posture and piloerection were observed from 30 min. p.a. onwards up to 6 hours. From Day 1 to the end of the observation period, the animals were free of any abnormalities.
- Gross pathology:
- No specific findings
Any other information on results incl. tables
Table for Acute Oral Toxicity of TPI 1618 |
|||
Dose [mg/kg bw] |
Number of dead / |
Time of death (range) |
Observations |
2000 |
females 0/4 |
n.a. |
Clinical signs:
|
LD50value (females) |
> 2000 mg/kg bw |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of the study indicate that the acute oral toxicity in female animals was above 2000 mg/kg body weight.
- Executive summary:
Study was performed according to OECD guideline 420 (fixed dose procedure). One dose level of 2000 mg/kg bw (limit test). was used and applied orally as single administration to 4 females rats.
All survivors were subjected to a 14 days post-treatment observation period. All rats were observed for clinical signs, body weight development. Macroscopic findings were recorded in all animals.No animal died. Clinical signs observed at the 2000 mg/kg dose level were piloerection and hunched posture p to 6 hours post dosing. Body weight development was within normal ranges. No macroscopic organ findings were observed at necropsy.
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