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EC number: 807-461-4 | CAS number: 1489170-67-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- see "Principles of method if other than guideline" for further information
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- yes
- Remarks:
- see "Principles of method if other than guideline" for further information
- Principles of method if other than guideline:
- The standard deviation for the percentage viability results of the test item treated tissues exceeded the <18% assay acceptance criterion. The standard deviation for the three identically treated test item treated tissues was 19.4. However it was considered that this would not necessarily invalidate the results:
Unequivocal negative results were obtained for the three identically treated test item treated tissues. Also the negative and positive control tissues met the appropriate acceptance criteria. It was considered that the results of the study were acceptable on the basis that the test system proved sensitive to the positive control and the test item did not induce a response close to the irritation cut off of <50% for any of the three identically treated tissues. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- sodium 4-[(4-chlorobenzoyl)amino]benzoate
- EC Number:
- 807-461-4
- Cas Number:
- 1489170-67-3
- Molecular formula:
- C14H9ClNNaO3
- IUPAC Name:
- sodium 4-[(4-chlorobenzoyl)amino]benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Storage condition of test material: room temperature in the dark
- Description: white powder
Constituent 1
Test animals
- Species:
- other: EpiDermTM tissue consisting of human-derived epidermal keratinocytes
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg - Duration of treatment / exposure:
- 15 min
- Observation period:
- post incubation for 42h
- Number of animals:
- not applicable, 3 replicates / treatment group
- Details on study design:
- TEST SITE
- coverage: the test item was applied topically to the corresponding tissues ensuring uniform covering.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item.
- Time after start of exposure: 15 min
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: relative mean absorbance, MTT assay
- Value:
- 97.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: test item. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative mean absorbance, MTT assay
- Value:
- 14.9
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: positive control. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative mean absorbance, MTT assay
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15min + 42h. Reversibility: other: not applicable. Remarks: negative control. (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 97.4% (threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- The test item was classified as non-irritant. The following classification criteria apply:
EU DSD & CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
The study was performed under GLP according to OECD guideline 439 and EU Method B.46 and therefore reliability of Klimisch 1 has been assigned.
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