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EC number: 269-358-5 | CAS number: 68227-46-3
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1st October to 10th October 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No Guideline available however scientific principles of the study are well documented. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Type of study / information:
- The Neutral Red Uptake Bioassay was used to assess the toxicity of the test article to Balb/c 3T3 mouse fibroblasts (3T3) (American Type Culture Collection, Manassas, VA). The assay is an adaptation of the procedure described by Borenfreund and Puerner', and Babich, et al. The neutral red uptake bioassay is used to quantitatively measure the toxicity of a test article to Balb/c 3T3 cultures by comparing the neutral red dye (3-amino-7-dimethylamino-2-methyiphenazine hydrochloride) uptake of test article treated Balb/c 3T3 cultures to the neutral red uptake in control (media or solvent treated) Balb/c 3T3 cultures. The concentration of test article causing a reduction in neutral red uptake of 50% (NRU50) was determined.
The purpose of this study was to evaluate the toxicity of the test article, supplied by PPG Industries, Inc., as measured by the test article induced inhibition of neutral red uptake in Balb/c 3T3 cultures. The laboratory phase of this study was conducted from October 1, 2003 to October 10, 2003 at the Institute for In Vitro Sciences, Inc (IIVS). After a preliminary assay, the test article was tested in a valid definitive assay (eight dose levels) to determine the concentration of the test article resulting in the NRU50 end point.
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- n/a
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Lactic acid, compound with 3-[2-(dimethylamino)ethyl] 1-(2-ethylhexyl) toluene-2,4-dicarbamate (1:1)
- EC Number:
- 269-358-5
- EC Name:
- Lactic acid, compound with 3-[2-(dimethylamino)ethyl] 1-(2-ethylhexyl) toluene-2,4-dicarbamate (1:1)
- Cas Number:
- 68227-46-3
- Molecular formula:
- C21H35N3O4.C3H6O3
- IUPAC Name:
- 2-hydroxypropanoic acid 2-(dimethylamino)ethyl N-[5-({[(2-ethylhexyl)oxy]carbonyl}amino)-2-methylphenyl]carbamate
- Details on test material:
- - Name of test material (as cited in study report): WRS-2390
- Physical state: Vicous liquid
- Storage condition of test material: Stored at room temperature and protected from light.
Constituent 1
Results and discussion
Any other information on results incl. tables
Definitive Neutral Red Uptake Assay:
The below tables gives the NRU50 results for the definitive neutral red uptake assay for the test article and the positive control. The NRU50 value of the positive control, SLS, was within the expected range seen historically.
Test Articles | Sponsor designation | NRU50 (µg/ml) | pH (712 mg/mL in water) | pH* (20 mg/mL in CDM) | |
Preliminary (10/1/03) | Trial 1 (10/8/03) | ||||
03AH00 | WRS-2390 | 5.5 | 18.2 | NCC | 8.5 |
SLS | Positive Control | 25.5 | 36 | NA | NCC |
* - pH of highest test article concentration prepared in Chemical Dilution Medium
NA - Not Applicable
NCC - Not able to be determined, since a color change was not observed on the pH paper.
The following calculation was performed to determine the estimated LD50 of the test article based on the NRU50 result of the definitive assay. The regression formula is based on the results of testing the reference chemicals with mouse fibroblasts in the BALB/c 3T3 Neutral Red Uptake Cytotoxicity test, published in the Guidance Document on Using in vitro Data to Estimate
in vitro Starting Doses for Acute Toxicity (August 2001, NIH Publication No. 01-4500).
Log (LD50) = 0.435 x log (NRU50 in mmol/L) + 0.625
NRU50 = 18.2 µg/mL = 0.0182 mg/mL
Formula Weight of WRS-2390 = 483
NRU50 in mmol/L = 0.037681 mmol/L
Estimated log (LD50) = 0.00561 mmol/kg
Estimated LD50 = 1.01 mmol/kg = 489 mg/kg
Applicant's summary and conclusion
- Conclusions:
- The Estimated LD50 = 1.01 mmol/kg which is equivalent to 489 mg/kg. The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability & repeatability).
- Executive summary:
In a Neutral red uptake bioassay in balb/c 3T3 mouse fibroblast study (Institute for In Vitro Sciences, Inc. Study number: 03AH00.100068) the test material had an estimated LD50 of 1.01 mmol/kg, which is equivalent to 489 mg/kg.
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