Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-576-0 | CAS number: 97-36-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2',4'-dimethylacetoacetanilide
- EC Number:
- 202-576-0
- EC Name:
- 2',4'-dimethylacetoacetanilide
- Cas Number:
- 97-36-9
- Molecular formula:
- C12H15NO2
- IUPAC Name:
- 2',4'-dimethylacetoacetanilide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-m-xylidid
- Product code: HEAT 105
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- Identification: Numbered earmark
- Weight: 2.1 - 2.6 kg
- Age: approx. 3 to 5 months
- Housing: in air conditioned rooms in single cages
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Feed: Altromin 2123 - rabbit, ad libitum, as well as hay (approx 15 g daily)
- Water: deionised, chlorinated water from automatic dispensers, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye served as control.
- Amount / concentration applied:
- - Amount applied: 100 mg
- Duration of treatment / exposure:
- Exposure period: 24 hrs. At the end of exposure the treated eye was rinsed with physiol. saline (37°C).
- Observation period (in vivo):
- 1, 24, 48, 72 hrs after test substance application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Approx. 24 hrs before the start of study the eyes to be treated where examined for damages to the cornea using ultraviolet light. Eyes were instilled with fluorescin-sodium solution (0.01 %) before
- Eyes were washed with physiol. saline solution (approx 37 °C) 24 hrs after treatment with the test substance and at all other observation times where discharge was observed or the cornea was examined for damages.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- other: initial slight effects were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1, 2, 3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: # 1, 2, 3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effects at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effcts at any time
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test, the test substance is not eye irritating.
- Executive summary:
The test substance was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as control. 24 h after instillation eyes were rinsed with physiol. saline. The eyes were examined at 1, 24, 48, and 72 h after substance application. Mean scores (mean of 24, 48, 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.
Mean scores for cornea, iris, and conjunctivae chemosis were 0 and for conjunctivae redness was 0.3 (in each animal tested). All effects were reversible within 48h.
Based on the findings in this test, the test substance is not eye irritating.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.