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EC number: 224-638-6 | CAS number: 4433-79-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP and OECD guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- EC Number:
- 224-638-6
- EC Name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- Cas Number:
- 4433-79-8
- Molecular formula:
- C12H14ClNO4
- IUPAC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): Naphtol AS IRG TTR
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Number of animals for each pre-test (non GLP): 2 females
Number of animals for the main study: 16 females
Number of animals per group 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) group: 1
Age 8-12 weeks (beginning of acclimatisation)
Identification: Single caging. The animals will be distributed into the test groups at random and identified by cage number
Acclimatisation: Unter test conditions after health examination. Only animals without any visible signs of illness will be used for the study
Housing: single
Cage Type: Makrolon Type 1, with wire mesh top
Bedding: granulated soft wood bedding
Feed: pelleted standard diet, ad libitum
Water: tap water, ad libitum
Environment: temperature: 22 +/- 3 °C
rel. humidity approx: 30-83 %
artificial light: 6 a.m. - 6 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Doses: 0 (control group), 5, 10, 25 % (w/v, in DMSO)
- No. of animals per dose:
- 4 per dose group
- Details on study design:
- For determination of the highest non-irritant and technically applicable test item concentration, a pretest was performed on two mice with concentrations of 2.5, 5, 10 and 25 % (w/v). The top dose of the test item is the highest technically achievable concentration whilst avoiding systemic toxicity an excessive local irritation.
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (stimulation index: S.I.).
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentrations resultes in 3-fold or greater increase in incorporation of 3HTdR compared to the concurrent control, as indicated by the stimulation index (S.I.) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical analysis was conducted for assessment of the dose-response relationship and the EC3 value was calculated according to the equation
EC3 = (a-c)[3-d)/(b-d)]+c with EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are the coordinates of the two pair of data lying immediately above and below the S.I. (stimulation index) value of 3 on the LLNO dose response blot
Results and discussion
- Positive control results:
- April 2004: EC3 = 6.3%
October 2004: EC3 = 9.9%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%: 1.7 10%: 1.8 25%: 1.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per lymph node: Control Group : 389.6 5%: 660.6 10%: 701.8 25%: 512.7
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Naphtol AS IRG TTR was found to be not a skin sensitiser in this assay.
- Executive summary:
In the study the test item Naphtol AS IRG TTR dissolved in DMSO was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 5 %, 10 %, and 25 %.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.7, 1.8, and 1.3 were determined with the test item at concentrations of 5.0, 10.0, and 25.0 % (w/v) in DMSO.
The test item Naphtol AS IRG TTR was found to be not a skin sensitiser in this assay.
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