Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 OECD404, 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 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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: 2.2 - 3.7 kg
- Housing: in fully air-conditioned rooms in separate cages 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
- Acclimatization: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- not required
- Amount / concentration applied:
- 500 mg / 0,3 ml vehicle per animal
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g 3-Amino-4-methylbenzamide pasted with 0.3 ml deionized water. The substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced byBeiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE (see Appendix "Scale for scoring dermal reactions", page 11). All other changes of the skin were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all tested animals
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h after patch removal
- Remarks on result:
- other: highest mean score of a single animal: 0.33 for 1 of 3
- Irritation parameter:
- edema score
- Basis:
- animal: # 1-3 each
- Time point:
- other: mean of 24, 48, 72 h after beginning of treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect occured
- Remarks on result:
- other: no effect on any single animal
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification acc. to (EC) 1272/2008: not irritating
- Executive summary:
Test material was subject to a test of skin irritancy according to OECD Guideline 404. 500 mg of substance were applied to the skin of three rabbits under semi-occlusive conditions for 4 h. The scoring of skin reactions was performed after 24, 48 and 72h h after end of exposure.Mean values of the 24, 48 and 72 h readings were calculated for each animal.
Only slight effects (erythema mean score: <=0.33, edema mean score: 0) below the threshold for classification were determined for the intact skin. All effects were fully reversible. Based on these findings the test material was judged not to be irritating to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.