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EC number: 246-910-3 | CAS number: 25376-45-8
- 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
- Study period:
- From January 1982 to March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: standardised study without detailed documentation. Compliance with GLP was not mentioned. Purity of the test substance unknown.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diaminotoluene
- EC Number:
- 246-910-3
- EC Name:
- Diaminotoluene
- Cas Number:
- 25376-45-8
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 3-methylbenzene-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): m-toluylendiamin
no other data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill, Ltd. Huntingdon, England
- Age at study initiation: no data
- Weight at study initiation: 3,3-4,9 kg
- Housing: individually in cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): ca. 60
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- continuous (no wash)
- Observation period (in vivo):
- 7 days. The eyes were examined at 1, 24, 48, 72 hours, and day 7 after test substance application.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE No data
SCORING SYSTEM: similar to the commission Directive 2004/73/EC
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and day 7
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and day 7
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and day 7
- Score:
- 0 - 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and day 7
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- See table 1 in field "remarks on results including tables and figures".
- Other effects:
- None
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point/ Reversibility | Cornea Max. score: 4 |
Iris Max. score: 2 |
ConjunctivaeMax. score: 3 | ChemosisMax. score: 4 |
60 min | -/0/- | -/0/- | -/0/- | -/1/- |
24h | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 |
48 h | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 |
72 h | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 |
average 24h, 48h, 72h | 0/0/0 | 0/0/0 | 0/0.33/0 | 0/0/0 |
Reversibility*) | - | - | c. (at day 7) | - |
Average time (day) for reversion | - | - | - | - |
*) Reversibility: c. = completely reversibility; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU and EU-GHS
- Conclusions:
- Under the conditions of this test, m-Toluylendiamin is not irritating according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.
- Executive summary:
In a primary eye irritation study (Starke B, 1982), 100 mg of m-Toluylendiamine (purity unknown) was intilled into the conjunctival sac of adult New Zealand White rabbits (1 male and 2 females). Animals were observed for 7 days. The eye irritation was assessed at 1, 24, 48, 72 hours and day 7 after administration. The mean score was calculated across 3 scoring time, 24, 48, 72 hours after instillation, for each animal separately.
The test item did not elicit any severe eye irritation at any of the observation time. Indeed, the individual mean scores for cornea, iris,
and chemosis were 0 and for conjunctivae 0.33. Redness had completely desappeared at day 7. Under the conditions of this test, m-Toluylendiamin is not an eye irritant according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.
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