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EC number: 243-039-0 | CAS number: 19406-86-1
- 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
- Study period:
- 2000 - 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study OECD405, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-amino-p-toluamide
- EC Number:
- 243-039-0
- EC Name:
- 3-amino-p-toluamide
- Cas Number:
- 19406-86-1
- Molecular formula:
- C8H10N2O
- IUPAC Name:
- 3-amino-p-toluamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Germany
- Strain: Albino New Zealand rabbit
- Age at study initiation: no data
- Weight at study initiation: 2.22 kg
- Housing: in fully air-conditioned room in a separate cage arranged in a battery
- Diet: ssnif~ K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eyes served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h after beginning of treatment
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- About 24 hours before the start of the study both eyes of the animal were examined
under UV light for corneal lesions after instillation of one drop of a 0.01 % fluoresceinsodium
solution. Only an animal without ocular abnormalities was used for the study.
100 mg 3-Amino-4-methylbenzamide was administered once to the conjunctival sac of
the left eye of the rabbit. The untreated eye served as a control.
24 hours after administration the treated eye was washed out thoroughly with isotonic
saline at approx. 37 °e. The eye was also washed out at designated examination times
at which discharge was observed or a corneal examination with fluorescein was
performed.
The eye was examined 1, 24, 48 and 72 hours after administration of the test substance.
At 24 and 72 hours and after 7 and 14 days, the eye was further examined for
corneal lesions under UV light after instillation of one drop of a 0.01 % fluoresceinsodium
solution. Lesions in cornea, iris or conjunctiva were graded numerically. All other changes or
toxic effects were recorded when apparent. Since effects were still present in the eye
after 72 hours, further examinations were carried out after 7 and 14 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- 14d after beginning of treatment (end of observation)
- Remarks on result:
- other: highest score of 2 after 72h remains unchanged after 14d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14d after beginning of treatment (end of observation)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14d after beginning of treatment (end of observation)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d after beginning of treatment (end of observation)
- Irritant / corrosive response data:
- In view of the unchanged cornea score of 2 after 14d after beginning of treatment a full recovery is not expected in the case of a prolonged observation period of 21 days according to effective guidelines.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification acc. to (EC) 1272/2008: H318 (causes serious eye damage).
- Executive summary:
Test material was subject to a test of eye irritancy according to OECD Guideline 405. 100 mg of substance were applied to one eye of 1 animal. Mean value of the 24, 48 and 72 h readings were calculated. Due to the effect on cornea not being expected to be fully reversible within 21 days according to effective guidelines the test material was judged to be causing serious damage to the eye.
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