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EC number: 213-611-4 | CAS number: 994-05-8
- 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
Endpoint summary
Administrative data
Description of key information
Based on the available human and animal data, TAME is not irritating to the skin, eyes and respiratory tract.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, no restrictions, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK
- Age at study initiation: not indicated
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: appr. 100-120 gram per animal/day
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/ artificial illumination from 6 to 18 hours - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral skin of each rabbit area acted as control.
- Amount / concentration applied:
- 500 µl TAME
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Draize scores were recorded for each animal at 1, 24, 48 and 72 hours and 7 days after the application of the substance.
- Number of animals:
- 3
- Details on study design:
- A semiocclusive patch was used to cover a clipped patch on the dorso-lateral area of the trunk to which 500 μl of the test substance had been applied. The patch was left in place for 4 hours after which the exposed skin area was washed carefully. The contralateral skin area acted as control. Dermal irritation was scored and the degree of erythema and oedema, together with any other lesions, was recorded. Draize scores were recorded for each animal at 24, 48 and 72 hours after the application of the substance. The index was separately calculated for erythema/eschar and oedema formation.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects were seen at all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects were seen at all
- Irritant / corrosive response data:
- All scores were zero at all time points. TAME was not irritating to albino rat skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, no restrictions, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK
- Age at study initiation: not indicated
- Weight at study initiation: 3.8 kg
- Housing: individually
- Diet: appr. 100-120 gram per animal/day
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / artificial illumination from 6 to 18 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the unexposed eye of each rabbit was the control
- Amount / concentration applied:
- 100 µl TAME
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Eye irritation was recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three albino rabbits were administered 100 μl TAME to the conjunctival sac of one eye while the other remained as an untreated control. 24 hours after instillation, the test substance of the treated eye was rinsed with saline. Eye irritation was scored according to Draize and recorded 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: maximal score (2) at 24 and 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects were seen at all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects were seen at all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 24 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: maximal score (4) at 1 hour. The effects were observed in only one of the animals.
- Irritant / corrosive response data:
- The data do not imply classifying TAME as an eye irritating substance.
- Other effects:
- Discharge (grade 2-3) was observed after 1 hour in all three animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
TAME did not cause skin irritation in a study conducted on three albino rabbits under semi occlusive dressing following OECD Guideline 404 and performed under GLP (Bayer AG, 1991a). All scores for erythema and oedema formation were zero at all time points.
The eye irritation potentail of TAME has been studied in a study with three albino rabbits following OECD Guideline 405 and performed under GLP (Bayer AG, 1991b). Slight redness and swelling of the conjunctiva were recorded; however, the effects were reversible within 7 days of instillation of the test substance.
No animal studies regarding respiratory tract irritation are available. In the acute inhalation toxicity study (exposure to 5400 mg/m3 for 4 hours, ITT Research Institute, 1991) rales were seen in all rats immediately following the exposure. The rales were present in 7/10 animals about 2 hours after the exposure, but 3 ¼ hours later all rats appeared normal. Redness around the nose was noticed in 7/10 rats during the study at 5400 mg/m3.
The inhalation repeated dose toxicity studies with rats and mice do not trigger a concern for respiratory tract irritation.
In a volunteer study with six humans (Pekari et al, 1997b, see section on acute toxicity for study summary), TAME caused only minor acute effects (exposure concentrations: 15 (60 mg/m3) and 50 (212 mg/m3)). Slight irritation of the eyes, nose and throat and drying of the mouth were reported. The effects were considered marginal and do not give reason to classify TAME for eye and respiratory tract irritation.
Justification for classification or non-classification
Based on the available data and in accordance with the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, eye and respiratory tract irritation.
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.
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