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Diss Factsheets
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EC number: 452-110-7 | 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:
- 2003-05-13 to 2003-09-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed in acordance to guideline with no deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): DEA/ACID ANHYDRIDE REACTION PRODUCT
- Physical state: highly viscous amber liquid
- Composition of test material, percentage of components:
Monomers: <17-35% (9-16% diethanolamine; 2-8% tetrahydrophthalic acid; 5-11% trimellitic acid; <0.1% tetrahydrophthalic anhydride; <0.8% trimellitic anhydride)
Dimers/trimers: <24-45%
Polymers: <10-25%
Not removable water: 5-15%
- Lot/batch No.: 200501.UN2810
- Expiration date of the lot/batch: september 2003
- Stability under test conditions: stable under storage condition
- Storage condition of test material: in the refrigerator in the original container away from direct sunlight
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rat, HanBrl: WIST (SPF)
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 246-257 g (male) and 187-196 g (female)
- Fasting period before study: No data
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70 % (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark, music during the light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: AAA reaction product was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL.
- Amount of vehicle (if gavage): AAA reaction product was administered at a volume dosage of 10 mL/kg.
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This trial formulation is excluded from the GLP statement of compliance.
- Lot/batch no. (if required): 442989/1 54502013
- Purity: No information
MAXIMUM DOSE VOLUME APPLIED: AAA reaction product was administered at a volume dosage of 10 mL/kg.
DOSAGE PREPARATION (if unusual): NA
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the expected low toxicity of AAA reaction product. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Six female HanBrl: WIST (SPF) rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during acclimatization and twice daily during days 1-15.
Body weights: on test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. - Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
- Clinical signs:
- other: Signs of toxicity related to dose levels: No clinical signs were observed during the course of the study.
- Gross pathology:
- Effects on organs: No macroscopic findings were recorded at necropsy.
- Other findings:
- - Organ weights: not examined
- Histopathology: not examined
- Potential target organs: NA
- Other observations: NA
Any other information on results incl. tables
NA
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute toxicity of AAA reaction prodcut was evaluated in accordance to OECD 423. The median lethal dose (LD50) after single oral administration to female rats, observed over a period of 14 days was found to be greater than 2000 mg/kg body bw.
- Executive summary:
The acute toxicity of AAA reaction prodcut was evaluated in accordance to OECD 423. Six female HanBrl: WIST (SPF) rats were treated with AAA reaction product by oral gavage administration at a dosage of 2000 mg/kg body weight.
All animals survived until the end of the study period. No clinical signs were observed during the course of the study. One animal showed a loss of body weight (2.3 %) and another animal did not gain body weight during the first observation week. Both animals recovered whereas a third animal lost body weight (0.6 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
The median lethal dose (LD50) after single oral administration to female rats, observed over a period of 14 days was found to be greater than 2000 mg/kg body bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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