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EC number: 277-874-7 | CAS number: 74441-06-8
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-N-[4-(aminocarbonyl)phenyl]benzamide
- EC Number:
- 277-874-7
- EC Name:
- 4-amino-N-[4-(aminocarbonyl)phenyl]benzamide
- Cas Number:
- 74441-06-8
- Molecular formula:
- C14H13N3O2
- IUPAC Name:
- 4-amino-N-(4-carbamoylphenyl)benzamide
- Details on test material:
- - Name of test material (as cited in study report): p-Aminobenzoylaminobenzamid TF
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals:
Animals: Young Adult New Zealand White Rabbit, SPF
Breeder: Harlan France, ZI Le Malcourlet, 03800 Gannat / France
Number of Animals per Test: 3 (Animals of both sexes were used)
Age (when treated): 11 weeks (male), 13 weeks (females)
Body Weight Range (when treated): 2245 g (male), 2323 - 2400 g (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination.
Environmental Conditions:
Room temperature 20 ± 3 °C
Relative humidity between 30-70%,
Light cycle: 12 hours light and 12 hours dark
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
Water: Community tap water from Füllinsdorf ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- The test item was administered at 0.5 g/animal. Before application the test item was moistened with approximately 0.5 mL of purified water.
- Duration of treatment / exposure:
- The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water.
- Observation period:
- 72 hours
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- Preparation of Dose Formulations:
p-Aminobenzoylaminobenzamid TF was used as delivered by the Sponsor and was moistened with approximately 0.5 mL of purified water before application. The pH of the test item was measured before the study initiation date. A formulation of a 1% (w/w) solution in purified water was prepared. The pH was found to be 5 – 6. According to Commission Regulation (EC) No. 440/2008, B.4. and OECD Guidelines 404, a test item needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties.
Observations:
Viability / Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical Signs (systemic): Daily from acclimatization of the animals to the termination of test.
Body Weights: At start of acclimatization, on the day of application and at termination of observation.
Observation and Scoring:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item). Data were summarized in tabular form, showing for each individual animal the irritation scores for erythema and oedema at all measurement intervals. Any lesions were described, including the degree and nature of irritation, corrosion or any other toxic effects observed, and their reversibility.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. According to Council Directive 67/548/EEC an animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema). According to Regulation (EC) No 1272/2008 an animal is positive when the mean score is 2.3 or greater. The test is positive for irritation when at least 2 animals are positive.
Pathology:
Necropsy: The animals were not sacrificed. No signs of irritation were observed on the treated skin following the application of the test item. For ethical reasons and in the interest of animal welfare, the animals were therefore re-used for the eye irritation study (Harlan Laboratories Study C57817) using the same test item.
Statistical Analysis:
No statistical analysis was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 94, 95, 96 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (erythema) at any time
- Irritation parameter:
- edema score
- Basis:
- animal: # 94, 95, 96 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (edema) at any time
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
No abnormal findings were observed on the treated skin of any animal 72 hours after treatment, the end of the observation time. - Other effects:
- No other effects reported.
Any other information on results incl. tables
Viability / Mortality:
No mortality occurred.
Clinical Signs:
No clinical signs were observed during the course of the study.
Body Weights:
The body weights of all rabbits were considered to be within the normal range of variability.
Coloration:
No staining produced by the test item of the treated skin was observed.
Corrosion:
No alterations of the treated skin were observed and no corrosive effects were evident on the treated skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based upon the classification criteria according to the Commission Directive 2001/59/EC of August 2001, p-Aminobenzoylaminobenzamid TF is considered to be “not irritating” to rabbit skin.
Based upon the classification criteria according to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008, p-Aminobenzoylaminobenzamid TF is not classified with respect to skin irritation in the rabbit. - Executive summary:
The primary skin irritation potential of p-Aminobenzoylaminobenzamid TF was investigated according to OECD test guideline No. 404 and Commission Regulation (EC) No. 440/2008, B.4. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours.
The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Thus, the test item did not induce significant or irreversible damage to the skin.
Based upon the classification criteria according to the Commission Directive 2001/59/EC of August 2001, p-Aminobenzoylaminobenzamid TF is considered to be “not irritating” to rabbit skin.
Based upon the classification criteria according to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008, p-Aminobenzoylaminobenzamid TF is not classified with respect to skin irritation in the rabbit.
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