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EC number: 211-322-8 | CAS number: 638-16-4
- 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
Endpoint summary
Administrative data
Description of key information
One in vivo test for the testing of skin corrosion and skin irritation was available. The test showed no skin irritant or corrosive effects. Therefore, the test substance was considered for no classification for skin corrosion/irritation.
One in vitro test for eye irritation according to OECD TG 492 was performed and showed no irritant effects.The test substance is classified as non-irritant in accordance with UN GHS No Category.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. - Dec. 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Analog hazardous substances, Part. 191, Section 11, FDA, Washington 1965
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: males/females 2.3 - 2.8 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 60 +/-3
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- open
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 1% methyhydroxyethylcellulose Gel MH 300 P
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 2.0 ml/kg
Concentrations of test material: 1. 30% solution, 2. 15% solution - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 0, 24 h, 48 h, 72 h, 14 days daily
- Number of animals:
- 36 in total, 3 per sex and group
- Details on study design:
- TEST SITE
- Area of exposure: 20 x 20 cm
Application of test substance: 1. intact skin 2. scarified skin
OBSERVATION
- clinical signs, water and food consumption, body weight were checked daily - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin, TMT solution 30%
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin, TMT solution 30%
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin, TMT solution 10%
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin, TMT solution 10%
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin, control animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- scarified skin, control animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritant response or serious lesion was noted during the 72-hour and 14 days observation period, no edema were present
- Other effects:
- No signs of incompatibility and no clinical effects, changes in water/food consumption or body weight gain were evident
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive or irritant effects. Based on these information, the test item does not require classification and labeling according to CLP Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.10.2019 to 18.11.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The MatTek EpiOcular™ model has been widely used as a research and testing model for many years.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg of test item
- Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- other: mean relative tissue viability [%]
- Run / experiment:
- 1
- Value:
- 72.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (72.8%). The test item is classified as “non-irritant“ in accordance with UN GHS “No Category”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion:
Taicros TMT was tested for acute dermal irritation/corrosion as 30% and 10% solution in a study comparable to guideline. No corrosive or irritant effects were evident for intact and abraded skin after direct exposure or during 14 days observation period.
No skin irritation was observed after a single dermal dose of 10.0 g/kg to 5 albino rabbits.
Eye irritation:
The eye irritating potential of TAICROS TMT was analysed according to OECD TG 492. In this study under the given conditions the test item showed no irritant effects.
Justification for classification or non-classification
Based on the available information and in the absence of irritating effects, the test substance Taicros TMT does not need to be classified for Skin Irrit./Corr. or Eye Irrit./Dam. according to CLP Regulation (EC) 1271/2008.
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