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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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): 12 weeks (male), 14 weeks (females)
Body Weight Range (when treated): 2597 g (male), 2754 – 2951 g (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Environmental Conditions:
Temperature: 17-23 °C and for
Relative humidity: 30-70% (values above 70% during cleaning process possible)
Light cycle of 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 4642 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control
- Amount / concentration applied:
- 0.1 g of p-Aminobenzoylaminobenzamid TF was placed in the conjunctival sac of the left eye of each animal. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
- Duration of treatment / exposure:
- Single application, the treated eyes were not rinsed after instillation.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- Purpose:
The purpose of this primary eye irritation study was to assess the possible irritation potential when a single dose of p-Aminobenzoylaminobenzamid TF is placed in the conjunctival sac of rabbit eyes. This study should provide a rational basis for risk assessment in man as ocular contact is one of
the possible routes of human exposure.
Preparation of Dose Formulations:
0.1 g (per animal) of p-Aminobenzoylaminobenzamid TF was weighed and applied undiluted as it was delivered by the Sponsor. The pH of a 1% (w/w) solution was measured for Harlan Laboratories Study C57806 (skin irritation with p-Aminobenzoylaminobenzamid TF) and was found to be 5-6.
According to Commission Regulation (EC) No 440/2008, B.4. and OECD Guidelines 405, a test item does not need 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.
Determination of Eye Irritating Potential:
Observation and Scoring: The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, at approximately 1, 24, 48, 72 hours after administration. Scleral reddening and ocular discharge were also assessed. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland). Data were summarized in tabular form, showing for each individual animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion. The evaluation of the results was performed according to the classification criteria of the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity 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 (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 94, 95, 96 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 94, 95, 96 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no signs of irritation (redness) at any time
- Irritation parameter:
- chemosis 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 (chemosis) at any time
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. All individual mean scores were 0.00 for all three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
No corrosion was observed at any of the measuring intervals.
One hour after test item instillation, slight reddening of the sclerae was noted in one female. In the treated eyes of all animals, beige test item remnants were still observed. No abnormal findings were observed in the treated eye of any animal 24 hours after treatment until the end of the observation period after 72 hours. - Other effects:
- No other effects
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 eye was observed.
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 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, p-Aminobenzoylaminobenzamid TF is not classified with respect to eye irritation.
- Executive summary:
The primary eye irritation potential of p-Aminobenzoylaminobenzamid TF was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. All individual mean scores were 0.00 for all three animals.
The instillation of p-Aminobenzoylaminobenzamid TF into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the sclerae in 1/3 animals. This effect was reversible and was no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea or iris or the conjunctivae of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
Based upon the classification criteria according to the Regulation Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, p-Aminobenzoylaminobenzamid TF is not classified with respect to eye irritation.
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