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EC number: 201-851-2 | CAS number: 88-68-6
- 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
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: modern guideline study, conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Anthranilamide
- EC Number:
- 201-851-2
- EC Name:
- Anthranilamide
- Cas Number:
- 88-68-6
- Molecular formula:
- C7H8N2O
- IUPAC Name:
- 2-aminobenzamide
- Test material form:
- other: solid
- Details on test material:
- Identification: Anthranilamide
Test Item No.: 15/0042-1
Batch: 0005190619
CAS-No.: 88-68-6
Content: w (main component): approx. 100.1 g/100 g Determined by potentiometric titration, for details see analytical report No.: 15L00067
Physical state, appearance: Beige solid
Homogeneity: The test item appeared to be homogeneous
Expiry Date: 19 January 2016
Storage Conditions: (provided by the Sponsor) At room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0.1, 0.25, and 0.5% (w/w)
- No. of animals per dose:
- 5 females (nulliparous and non-pregnant)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.21
- Test group / Remarks:
- 0.5% w/w
- Remarks on result:
- other: Mean SI (n=5)
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 0.25% w/w
- Remarks on result:
- other: Mean SI (n=5)
- Key result
- Parameter:
- SI
- Value:
- 1.18
- Test group / Remarks:
- 0.1% w/w
- Remarks on result:
- other: Mean SI (n=5)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: mean DPM (n = 5) 0.1%: 2440.5 +- 858.9 0.25%: 2720.1 +- 513.7 0.5%: 2509.1 +- 483.9
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Anthranilamide was not a skin sensitizer.
- Executive summary:
In order to study a possible skin sensitising potential of Anthranilamide, three groups each of five female mice were treated once daily with the test item at concentrations of 0.1, 0.25, and 0.5% in DMSO by topical application to the dorsum of each ear for three consecutive days. The test item could be dissolved in the vehicle. The appropriateness of the used concentrations was previously assessed by four pre-experiments. A control group of five mice was treated with the vehicle DMSO only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised, pooled per animal and immediately weighed. Furthermore, after excision of the lymph nodes, both ears of the mice were punched at the apical area using a biopsy punch and were immediately weighed pooled per animal using an analytical balance. Afterwards single cell suspensions of lymph node cells were prepared from pooled lymph nodes per animal. An aliquot of each cell suspension was used for determination of lymph node cell count. Subsequently the suspensions were washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter. The animals showed neither signs of systemic toxicity nor mortality during the course of the study. From day 3 to 5, the animals treated with 0.25 and 0.5% showed an erythema of the ear skin (score 1). A statistically significant or biologically relevant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, for BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation (see Ref. 9). None of the indices determined for the test item treated groups reached or exceeded this threshold. A test item is regarded as a sensitiser in the LLNA if exposure to one or more test item concentration results in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated test item concentration required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices (S.I.) of 1.18, 1.31, and 1.21 were determined with the test item at concentrations of 0.1, 0.25, and 0.5% (w/w) in DMSO, respectively. A statistically significant or biologically relevant increase in DPM value and also in lymph node weight and - cell count was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice (see Ref. 8) was not reached or exceeded in any dose group. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
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