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EC number: 201-064-4 | CAS number: 77-86-1
- 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
- Remarks:
- In vivo study with the rabbit
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 May - 21 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National GLP Compliance Monitoring Authority, Department of Science & Technology, New Delhi, India
Test material
- Reference substance name:
- Trometamol
- EC Number:
- 201-064-4
- EC Name:
- Trometamol
- Cas Number:
- 77-86-1
- Molecular formula:
- C4H11NO3
- IUPAC Name:
- 2-amino-2-(hydroxymethyl)propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Tris Amino Ultra Pure
- Physical state: white crystals
- Analytical purity: 99.9%
- Impurities (identity and concentrations): 0.018% (w/w) water
- Lot/batch No.: XK0731LA1C
- Storage condition of test material: at ambient temperature, 18-36 °C
- Recertification date: 22 Feb 2013
- pH: 10.4 (1% aqueous solution)
- Other: soluble in water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: in-house bred (Outbred); Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore, India- Age at study initiation: 7-8 months- Weight at study initiation: 2.84-3.06 kg- Housing: the rabbits were housed individually in rabbit cages (approximately L 65 cm x B 65 cm x H 45 cm) with a Noryl shallow cage body and Noryl waste trays. The litter collection trays were changed daily, except on Sundays.The feed hoppers and water bottles were changed weekly. - Diet: rabbit feed (Pranav agro Industries Ltd., Maharashtra, India), ad libitum - Water: deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier (manufactured by Eureka Forbes Ltd., Mumbai, India), ad libitum- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 21-23- Humidity (%): 59-67- Air changes (per hr): 12-15- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 13 May 2011 To: 21 May 2011
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: water was added to the test substance to make a paste
- Controls:
- other: not required, untreated sites of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hReading time points: 1, 24, 48 and 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE- Area of exposure: approximately 6 cm²- Type of wrap if used: the test substance was applied to the skin and the area was covered with a semi-occlusive patch. The patch was held in place with non-irritating semi-occlusive adhesive tape that was wrapped around the trunk of the animals. The rabbits were also fitted with an Elizabethan collar for 24 hours after application.REMOVAL OF TEST SUBSTANCE- Washing (if done): the application sites were washed with water and wiped clean with a towel to remove any residual test substance- Time after start of exposure: 4 hTEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g- For solids, paste formed: yesSCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation effects were observed; all scores were 0 at all reading time points for 3/3 animals.
- Other effects:
- There was no mortality and no clinical signs of toxicity were observed during the study period. The body weight gains were within the normal ranges during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- There were no skin reactions observed at any time point during the study.
CLP: not classified
DSD: not classified - Executive summary:
The acute dermal irritation study in rabbits was conducted to evaluate the skin irritation potential of Tris Amino Ultra Pure. Under the testing conditions of this study, the test substance Tris Amino Ultra Pure showed no evidence of dermal irritation. Five hundred mg (0.5g) of the test substance was made into a paste with a sufficient volume of water and mixed with a glass rod. The resulting paste was applied to the dose site and covered with a gauze pad of approximately 6 cm2 (2 x 3 cm - 6ply). The patch was secured to the body of the animal by a non-irritating semi-occlusive adhesive tape. After a 4-hour contact period, the bandage was removed and the dose site was wiped with water using clean towels. Three rabbits were treated at once. The degree of irritation was evaluated and scored by Draize’s evaluation method at 1, 24, 48 and 72 hours post removal of the test patch. There were no clinical signs of toxicity or pre-terminal deaths. There were no skin reactions observed at any time point during the study.
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