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EC number: 260-976-0 | CAS number: 57834-33-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 07, 2016 to January 25, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- EC Number:
- 260-976-0
- EC Name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Cas Number:
- 57834-33-0
- Molecular formula:
- C17H18N2O2
- IUPAC Name:
- ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Eversorb EP4
- Substance type: Liquid
- Composition of test material, percentage of components: 98.94%
- Lot/batch No.: 4023
- Storage condition of test material: Ambient
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: BioLASCO Taiwan Co. Ltd.
- Age at study initiation: about 7-8 weeks old (males); about 9-10 weeks old (females)
- Housing: Animals were individually housed with bedding and an enrichment toy.
- Acclimation period: 6 Days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- Water for Injection (WFI)
- Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg B.W.
- No. of animals per sex per dose:
- For Group 1: six male and six female
For Group 2: six male and six female - Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
Any other information on results incl. tables
Table 1. Clinical Observations
Dose (mg/kg) |
0 |
2000 |
Group |
1 |
2 |
Red lacrimation |
||
Male |
1/6 |
1/6 |
Female |
0/6 |
0/6 |
Red hair stain on nose |
||
Male |
5/6 |
5/6 |
Female |
3/6 |
5/6 |
Skin laceration on neck |
||
Male |
0/6 |
1/6 |
Female |
0/6 |
0/6 |
Skin scab/scar on neck/back |
||
Male |
1/6 |
1/6 |
Female |
0/6 |
0/6 |
Skin swelling on thorax |
||
Male |
0/6 |
0/6 |
Female |
0/6 |
1/6 |
Table 2. Body Weight and Body Weight Gains
Dose (mg/kg) |
0 |
2000 |
Group |
1 |
2 |
Male |
||
Body weight (g) |
||
D1 |
253 |
253 |
D15 |
343 |
349 |
Weight gain |
||
Absolute (g) |
+90 |
+96 |
Relative to D1 (%) |
+36% |
+38% |
Female |
||
Body weight (g) |
||
D1 |
233 |
230 |
D15 |
266 |
262 |
Weight gain |
||
Absolute (g) |
+33 |
+32 |
Relative to D1 (%) |
+14% |
+14% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 402 test method, the LD50 of Eversorb EP4 was greater than 2000 mg/kg B.W.. Therefore, Eversorb EP4 was Category 5 based on GHS criteria. According to CLP, category 5 is not used. The test substance is not classified.
- Executive summary:
This test using the procedures outlined in the QPS study for T65316017-GN and OECD 402 (OECD, 1987). Six male and six female Sprague-Dawley rats for each group were used in test. For Dose Group 2, 12 Sprague-Dawley ratsweredermally dosed with 2000 mg/kg B.W. of Eversorb EP4. All animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. In absence of mortality or other significant clinical signs of toxicity, LD50 of Eversorb EP4 was greater than 2,000 mg/kg B.W..
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