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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
Endpoint summary
Administrative data
Description of key information
The median lethal dose (LD50) was larger than 2000 mg/kg bw using oral and dermal application.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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. - 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
- Preliminary study:
- NA
- 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 - 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.
Reference
NA
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability score of 1- GLP study performed in acordance to guideline with no deviations
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-17 to 2003-09-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed in accordance to guideline with no deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rat, HanBrl: WIST (SPF)
- Age at study initiation: 8 - 9 weeks (male) and 11 - 12 weeks (female)
- Weight at study initiation: 246-257 g (male) and 187-196 g (female)
- Fasting period before study: No data
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type 3 cages with standard softwood bedding during treatment and observation.
- 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.
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10 % of the total body surface.
- % coverage: 10 % of the total body surface.
- Type of wrap if used: a patch covered with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution): No
- Constant volume or concentration used: No
- For solids, paste formed: No
VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): Na
- Lot/batch no. (if required): Na
- Purity: NA - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- A total of 10 animals included in the study (5 male and 5 female).
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily during acclimatization and twice daily during days 1-15 (mortality/viability); On test days 1 (prior to administration), 8 and 15 (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- No statistical analysis was used.
- Preliminary study:
- NA
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- NA
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose (LD50) of AAA reaction product following a single semi-occlusive dermal administration to rats of both sexes, was found to be greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of AAA reaction product was evaluated in accordance to OECD 402. Five male and five female HanBrl: WIST (SPF) rats were treated with AAA reaction product at 2000 mg/kg by dermal application (undiluted). The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, body weight, viability and clinical signs were recorded. At termination. all animals were necropsied and examined macroscopically.
No deaths occurred during the study.Three female animals showed a loss of body weight (1.5 % to 4.7 %) during the first observation week and recovered from test day 8 to 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 observed at necropsy.
The median lethal dose (LD50) of AAA reaction product following a single semi-occlusive dermal administration to rats of both sexes, was found to be greater than 2000 mg/kg bw.
Reference
NA
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliability score of 1- GLP study performed in acordance to guideline with no deviations
Additional information
Annex VIII requirement for second exposure route is fulfilled as both an acute oral and an acute dermal toxicity study is availabe. No inhalation study available.
Justification for selection of acute toxicity – oral endpoint
Only acute toxicity study available using the oral route
Justification for selection of acute toxicity – dermal endpoint
Valid study. No other dermal acute toxicity study.
Justification for classification or non-classification
Based on the available acute oral and dermal toxicity data, AAA reaction product is not to be classified according to criteria in GHS/CLP regulation.
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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