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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
One available oral study with rats resulted in a combined LD50 value of 2152 mg/kg. Females appeared to be more sensitive as the LD50 was 1602 mg/kg for females. For males the LD50 was 2417 mg/kg.
The LC50 value via inhalation is over 5400 mg/m3 in rats.
The LD50 value after dermal exposure was higher than 2000 mg/kg bw in rabbits.
In humans, TAME caused slight acute toxic effects at concentrations of 15 (64 mg/m3) and 50 ppm (212 mg/m3).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, comparable to guideline study with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 200-350 gram
- Fasting period before study: overnight prior to dosing
- Housing: 5 per cage/per sex/per dose
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 68-76 degrees Fahrenheit
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1989-03-28 To: 1989-04-11 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- vehicle: none
exposure: by oral intubation via syringe and a No. 13 stainless steel straight, ball-tipped feeding needle
- Doses:
- 2000, 2500 and 3000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The dose range was based on a range-finding study. Clinical observations were recorded at 1, 2, 4 and 6 hours after dosing and once daily for 14 days after dosing. Body weights were recorded on the day before dosing, the day of the dosing (day 0), day 7 and day 14 and at termination followed by a gross necropsy.
- Statistics:
- The body weights were analysed using standard deviations.
The LD50-value was calculated using the Litchfield-Wilcoxon method with equal weighing of the data points. - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 417 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 602 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 152 mg/kg bw
- Mortality:
- Four animals died in the 2000 mg/kg bw group, seven animals in the 2500 mg/kg bw group and eight animals in the 3000 mg/kg bw group. One animal was found dead on day 0 but this was thought to have resulted from a dosing error. The animal was replaced by another.
- Clinical signs:
- other: Clinical observations showed typical signs of sedation and included, for example, ataxia, emaciation, prostration, hypothermia, hypoactivity, dyspnoea, hypopnea, wet and dry rales, both clear and red nasal and oral discharge, staining of the fur and piloe
- Gross pathology:
- The animals that died showed in gross necropsy abnormalities of the gastro-intestinal tract and the urinary bladder, discolouration of the thymus, lungs and liver and staining of the fur. There was a single incident of enlarged heart atrium and one of dilated pelvis in both kidneys. Surviving animals had no observable abnormalities apart from a single incidence of dilated kidneys and one liver abnormality in the 2500 mg/kg bw group.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 152 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, comparable to guideline study with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river Breeding lab. Inc., Portage, MI
- Weight at study initiation: 225-319 gram
- Housing: individually in stainless steel cages, exposure in 1m3 glass and stainless steel chambers (Unifab, Kalamazoo, MI)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: approximately 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5
- Humidity (%): 36.2
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- The animals were exposed for 4 hours to a test atmosphere generated from a single batch of the test article. The generation system consisted of a glass column packed with glass beads. The test article was delivered at a constant rate from a glass reservoir. Compressed air entered at the bottom of the glass bead column and test article entered approximately at the middle of the column. The resultant vapour entered the chamber supply air duct and was carried into the top of the chamber. The test article was completely vapourized with only a slight discolouration of the glass beads. The amount of residue on the beads was too small to measure.
The exposure was conducted in 1m3 glass and stainless steel chambers (Unifab, Kalamazoo, MI). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- the test article vapour concentration was monitored by IR
- Duration of exposure:
- 4 h
- Concentrations:
- 5400 mg/m³
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Five male and five female Sprague-Dawley rats were assigned to a single group, which was exposed in a 1 m3 exposure chamber to a mean TAME vapour concentration of 5,400 mg/m3 for 4 hours. The rats were clinically observed immediately after removal from the chamber, approximately 2 to 3 hours after the exposure and at least once per day during the 14-day post exposure observation period. Rats were weighed before the exposure, one week later and before necropsy.
Examinations performed: clinical observations, body weights, gross necropsy. - Statistics:
- Statistical analyses were used to analyse the results: calculation of standard deviations.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 400 mg/m³ air
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: In clinical observations, 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 in 7/10 rats, salivat
- Body weight:
- All rats gained weight during the study.
- Gross pathology:
- Necropsy revealed external haemorrhagic lung foci in the lungs in seven rats. However, mostly these foci were comparable in size and number to control rat foci, with the exception of one female rat that had numerous foci. One male that had a diffuse red area on its lungs. Six rats had enlarged mandibular lymph nodes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 400 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Johnson Rabbit Ranch (Wilkinson, IN)
- Age at study initiation: 3-4 months
- Weight at study initiation: 3.16-3.30 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 32
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 240 cm2 (fur was clipped from the exposure sites)
- Type of wrap if used: application site (12.8 x 11.5) covered with surgical dressing and covered with plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with light mineral oil
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: up to 14 days
- Frequency of observations and weighing: 0.5, 0.75, 2, 3, 4.25 and 6 hours after dosing and once a day for 14 days after removal of wrappings
- Examinations performed: clinical signs, skin abnormalities, body weights, gross necropsy. - Statistics:
- Statistical analyses were used to analyse the results: calculation of standard deviations.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: One rabbit was vocal immediately upon test article administration. All of the rabbits exhibited rapid respiration lasting 1-2 hours after dosing.
- Gross pathology:
- Gross necropsy findings were within normal limits in eight rabbits. One male had white areas on its liver, while a female had only one kidney which was enlarged; these conditions were not considered treatment related.
- Other findings:
- Dermal irritation (i.e., edema and erythema) was observed within the application site of all rabbits following removal of the wrappings, and eschar formation developed in all rabbits 2 to 7 days later. The scab formation in 3 rabbits sloughed off prematurely, probably as a result of grooming, and raw skin was exposed beneath. New and/or repaired skin was observed in six rabbits, while seven rabbits displayed superficial flaking at the application site. None of the rabbits completely recovered from all signs of dermal irritation before the end of the 14-day observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
One acute toxicity (GLP-compliant, near-guideline) study with rats (Exxon Biomedical Sciences Inc., 1989) was available for assessment. The groups of 5 male and 5 female Sprague-Dawley rats were exposed by gavage to undiluted substance at 2000, 2500 and 3000 mg/kg bw. The combined LD50 value for male and female rats was determined to be 2152 mg/kg bw. Females appeared to be more sensitive than males, as the LD50 for females was 1602 mg/kg bw, compared to the LD50 of 2417 mg/kg bw for males. Clinical observations showed typical signs of sedation and included, for example, ataxia, emaciation, prostration, hypothermia, hypoactivity, dyspnoea, hypopnea, wet and dry rales, clear and red nasal and oral discharge, staining of the fur and piloerection. These observations were most prevalent during day 0 and day 1 in all groups. The animals that died showed abnormalities of the gastro-intestinal tract and the urinary bladder, discoloration of the thymus, lungs and liver and staining of the fur.
One acute inhalation toxicity (GLP-compliant, near-guideline) study with rats exposed to TAME was available for assessment (IIT Research Institute, 1991a). A single group of 5 male and 5 female Sprague-Dawley rats was exposed to TAME vapour at 5400 mg/m3 for 4 hours. None of the animals died. The LC50 value was determined to be > 5400 mg/m3. Regarding clinical observations, 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. Necropsy revealed external haemorrhagic lung foci in the lungs in seven rats. However, mostly these foci were comparable in size and number to control rat foci, with the exception of one female rat that had numerous foci and one male that had a diffuse red area on its lungs. Six rats had enlarged mandibular lymph nodes.
One acute dermal toxicity study with rabbits, performed under GLP and according to a procedure comparable with OECD Guideline 402, was available for assessment (IIT Research Institute, 1991b). TAME was applied undiluted at a dose of 2000 mg/kg bw to the shaved backs of five male and five female New Zealand White rabbits. The test site was covered with an occlusive dressing. No deaths occurred during the study. The LD50 for TAME was estimated to be greater than 2000 mg/kg bw.
Dermal irritation (i.e. edema and erythema) was observed within the application site of all rabbits after the removal of the wrappings, and eschar formation developed in all rabbits 2 to 7 days later. The scab formation in 3 rabbits sloughed off prematurely probably as a result of grooming, and raw skin was exposed beneath. New and/or repaired skin was observed in six rabbits, while seven rabbits displayed superficial flaking at the application site. None of the rabbits completely recovered from all signs of dermal irritation before the end of the 14-day observation period.Regarding the observed dermal irritation, given the occluded conditions used in this test, the skin irritation study with TAME (see section on skin irritation) is considered more relevant for drawing a conclusion on skin irritation.
In a volunteer study with six humans (men) per group (Pekari et al, 1997b), TAME caused only minor acute effects (exposure concentrations: 15 ppm (60 mg/m3) and 50 ppm (212 mg/m3)). The reporting on the effects is somewhat inconsistent and not very firm conclusions can be drawn from the study. Feelings characterised as heaviness of the head seemed to correlate inversely with increasing TAME concentration. Concentrations up to 50 ppm did not have an effect on reaction time, balance or mood during/after 4-hour exposure. In conclusion, 50 ppm (212 mg/m3)) is considered the NOAEC in this study.
Justification for classification or non-classification
Based on the oral LD50 value for female rats, TAME has to be classified according to the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 for acute toxicity by the oral route as Cat. 4 - H302 (Harmful if swallowed). No classification for acute inhalation and dermal toxicity is warranted.
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