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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-07-01 to 2003-09-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed in accordance 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White Rabbit, SPF
- Age at study initiation: 10 - 11 weeks (male), 10 - 11 weeks (females)
- Weight at study initiation: 1966 g (male), 2187 g (female), 2112 g (female)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 28/03).
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 2003-06-12 to 2003-06-16
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): utomatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
IN-LIFE DATES: 2003-06-12 to 2003-06-20
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): NA
VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): NA
- Lot/batch no. (if required): NA
- Purity: NA - Duration of treatment / exposure:
- 0.1 mL installed into the left conjuctival sac of the left eye of each of the animals. The right eye remained untreated and served as reference control.
- Observation period (in vivo):
- 1, 24, 48, 72 hours and after 7days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: The test substance was not removed after installation
SCORING SYSTEM: The ocular reaction (corneal opacity, area, iris, conjunctivae (redness and chemosis) and schlera) was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48, 72 hours and 7 days after application.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth Ag, Ch-4153 Reinach/Switzerland)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritant / corrosive response data:
- The application of AAA reaction product to the eye resulted in slight swelling of the conjunctivae (chemosis) in 1 animal at the 1 hour reading. Slight reddening of the conjunctivae was observed in all animals at the 1- and 24-hour reading. Slight reddening was still evident in two animals 48 hours after treatment and persisted in on animal up to the 72-hour examination. Slight reddening of the schlerae was visible in one animal 1 hour after treatment. No ocular discharge was observed in any animal. No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. No staining or corrosion was observed.
- Other effects:
- The bodyweights of all rabbits were considered to be within the normal range of variability.
The bodyweights of all rabbits were considered to be within
the normal range of variability.
Any other information on results incl. tables
Overall assessment of irritation scores in accordance to EEC grading system
Corneal opacity: Not irritating
Iris: Not irritating
Conjunctivae - Redness: Not irritating
Conjunctivae - Chemosis: Not irritating
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritation potential of AAA reaction product to the rabbit eye was evaluated in accordance to OECD 405. AAA reaction product did not induce significant or irreversible damage to the rabbit eye and is therefore considered to be "not irritant" to the rabbit eye. No classification is applied.
- Executive summary:
The primary eye irritation potential of AAA reaction product was evaluated in accordance to OECD 405. AAA reaction product was applied by installation of 0.1 mL into the left eye of each of 3 rabbits, the right eye serving as control. Scoring of irritation was performed after 1, 24, 48, 72 hours and after 7 days.
The individual mean scores for corneal opacity and iris were 0.00 for all 3 animals. The individual mean scores for conjuctivae were 0.67, 0.33 1.00 for reddening and for all 3 animals 0.00 for chemosis, respectively.
The instillation of AAA reaction product into the eye resulted in mild , early-onset and transient ocluar changes
No ocular discharge was observed in any animal. No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. No staining or corrosion was observed. Further, no other clinical signs were observed.
AAA reaction product did not induce significant or irreversible damage to the rabbit eye and is therefore considered to be "not irritant" to the rabbit eye. No classification is applied.
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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