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EC number: 219-529-5 | CAS number: 2455-24-5
- 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
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Subacute study; oral (gavage); rat (Sprague Dawley), m/f (OECD guideline 422, GLP): NOAEL = 300 mg/kg bw/d
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-08-14 to 2013-10-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- adopted on 22 March 1996
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Hsd: Sprague Dawley SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia SpA, Italy
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 176 to 200 g (males), 151 to 175 g (females)
- Housing: up to 5 of one sex/cage, in polisulphone solid bottomed cages measuring 59.5x38x20 cm; nesting material was provided inside suitable bedding bags and changed at least twice a week
- During mating, animals were housed one male to one female in clear polycarbonate cages measuring approximately 43x27x19 cm with a stainless steel
mesh lid and floor, each cage tray held absorbent material which was inspected and changed daily
- After mating, the males were re-caged as they were before mating, the females were transferred to individual solid bottomed cages for the gestation period, birth and lactation; suitable nesting material was provided and changed as necessary
- Diet (e.g. ad libitum): laboratory rodent diet (4 RF 21, Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI), Italy), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±2°C
- Humidity (%): 55%±15%
- Air changes (per hr): 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The formulations were prepared daily.
VEHICLE
- Concentration in vehicle: 10, 24 and 60 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration and homogeneity of the low and high dose level were assessed by taking six analytical aliquots (approximately 1 g) in different positions. For the intermediate levels, only concentration was assessed by taking two different analytical aliquots (approximately 1 g).
- Duration of treatment / exposure:
- mailes: 29 d (2 consecutive weeks prior to pairing and thereafter through the day before necropsy)
females: 29 d (2 consecutive weeks prior to pairing and thereafter during pairing, post coitum and post partum periods until Day 3 post partum or the day before sacrifice) - Frequency of treatment:
- daily, 7 d / week
- Remarks:
- Doses / Concentrations:
0, 50, 120, 300 mg/kg bw/d
Basis:
actual ingested - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for animal assignment: computerised stratified randomisation to give approximately equal initial group mean body weights
- Observations and examinations performed and frequency:
- CLINICAL SINGS AND MORTALITY: Yes
- Time schedule: at least once daily, approximately 0.5-1 hour after dosing
DETAILED CLINICAL OBSERVATIONS: Yes (Functional Observation Battery Tests)
- Time schedule: once before commencement of treatment and at least once a week thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: weekly; females additionally on Days 0, 7, 14 and 20 post coitum, dams with live pups were also weighed on Days 1 and 4 post partum
FOOD CONSUMPTION AND COMPOUND INTAKE: yes
-Time scedule: weekly during the pre-mating period, Individual food consumption for the females was measured on Days 7, 14 and 20 post coitum starting from Day 0 post coitum and on Day 4 post partum starting from Day 1 post partum
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day of necropsy
- Anaesthetic used for blood collection: Yes (isofluorane)
- Animals fasted: Yes
- How many animals: 5 males and 5 females randomly selected from each group
- Parameters: Haematocrit, Haemoglobin, Red blood cell count, Reticulocyte count, Mean red blood cell volume, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, White blood cell count, Differential leucocyte count (Neutrophils, Lymphocites, Eosinophils, Basophils, Monocytes, Large unstained cells), Platelets, Prothrombin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day of necropsy
- Anaesthetic used for blood collection: Yes (isofluorane)
- Animals fasted: Yes
- How many animals: 5 males and 5 females randomly selected from each group
- Parameters: Alkaline phosphatase, Alanine aminotransferase, Aspartate aminotransferase, Gamma-glutamyltransferase, Urea, Creatinine, Glucose, Triglycerides, Bile acids, Inorganic phosphorus, Total bilirubin, Total cholesterol, Total protein, Albumin, Globulin, A/G Ratio, Sodium, Potassium, Calcium, Chloride
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: once during the study, towards the end of treatment,
- Dose groups that were examined: all groups, 5 males and 5 females
- Battery of functions tested: sensory activity / grip strength / motor activity
OTHER:
Details on reproductive parameters are given in IUCLID section "Toxicity to reproduction" - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table) - Other examinations:
- Examination of pups and reproductive indices are detailed in IUCLID section "Toxicity to reproduction"
- Statistics:
- Standard deviations were calculated as appropriate. For continuous variables the significance of the differences amongst group means was assessed by Dunnett’s test or a modified t test, depending on the homogeneity of data.
Statistical analysis of histopathological findings was carried out by means of the non-parametric Kolmogorov-Smirnov test if n was more than 5. The non-parametric Kruskal-Wallis analysis of variance was used for the other parameters. Intergroup differences between the control and treated groups were assessed by the non-parametric version of the Williams test. The criterion for statistical significance was p<0.05. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality occurred during the study. No significant clinical signs were observed.
Observation of animals at removal from the cage and in an open arena (neurotoxicity assessment) did not reveal changes attributable to the test item.
BODY WEIGHT AND WEIGHT GAIN
No relevant differences were found in body weight and body weight gain between male groups throughout the study and between female groups up to Day 14 of post coitum period. On Day 20 post coitum, a decrease in body weight and body weight gain (statistically significant) was evident in females dosed at 300 mg/kg bw/day respect to controls.
FOOD CONSUMPTION
Decreases in food consumption were seen in the high dose female (300 mg/kg bw/day) group when compared with controls during the post coitum and post partum periods with statistical significance on Days 7 and 14 post coitum and 4 post partum. No differences were observed in males or between the other treated female groups compared to the control group.
HAEMATOLOGY
When compared with controls, a number of treated males showed slight to moderate thrombocytopenia and leucopenia, with no dose-relation. In particular, platelets were decreased in males dosed with 50 mg/kg bw/day (15%) and 300 mg/kg bw/day (23%) and leucocytes (mainly neutrophils, lymphocytes and basophils) were decreased by 21%, 40% and 25% in those receiving 50, 120 and 300 mg/kg bw/day, respectively. Leucopenia was also recorded in females dosed with 300 mg/kg bw/day (19%). However, the decrement comprised mainly neutrophils and eosinophils. In addition, females dosed with 120 mg/kg bw/day and 300 mg/kg bw/day showed slight increase of erythrocytes, haemoglobin and haematocrit (6% to 16%) associated with reticulopenia (55%) and slight decrease of mean corpuscular haemoglobin concentration (4%) in females dosed at 300 mg/kg bw/day. Due to the low severity and the absence of consistency between sexes, changes of the red series were considered of no toxicological importance.
A statistically significant increase of prothrombin time was recorded in animals dosed with 300 mg/kg bw/day (7% in males, 17% in females).
CLINICAL CHEMISTRY
Increase of phosphorus was recorded in males receiving 300 mg/kg bw/day (14%). Due to the absence of other related findings, this change was considered of no toxicological importance.
Females receiving 300 mg/kg bw/day showed slight decrease of alanine aminotransferase (57%), aspartate aminotransferase (29%), urea (39%) and sodium (7%) and increase of glucose (48%). The findings observed included mainly liver and metabolic parameters but the magnitude and/or the direction of changes was insufficient to represent a liver injury.
NEUROBEHAVIOUR
Motor activity was unaffected by treatment. Variations recorded in the sensory reaction to stimuli measurements, performed at the end of the treatment period, were considered of no toxicological significance since they were inconsistent between sexes, low in magnitude and withouth dose relationship.
ORGAN WEIGHTS
Terminal body weight was unaffected by treatment. Absolute and relative thymus weights were slightly reduced in mid- and high dose males compared to controls. High dose females (300 mg/kg bw/day) showed a slight reduction in absolute and relative adrenals weights.
GROSS PATHOLOGY
No remarkable changes were noted at post mortem examination in treated animals, when compared with controls.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment-related changes were noted. Periportal hepatocytic vacuolation, consistent with fatty change like associated in most instances with inflammatory cell foci and in few instances with single cell apoptosis/necrosis, was seen in a single control male and female and with an increased incidence in treated males and females. However, considering that the liver pathologyshowed a different incidence between treated males and females, without any dose-relation and that the pathological picture was similar to that observed in male and female controls, such changes could be attributed to spontaneous or incidental pathology rather than to the treatment. Lymphoid depletion in the thymus was only noted in 2 out of 10 high dose females (300 mg/kg bw/day) and was considered unrelated to treatment. The sporadic lesions reported in control and treated animals were considered to be an expression of spontaneous and/or incidental pathology, commonly seen in this species and age under our experimental conditions.
OTHER FINDINGS
Details on reproductive and developmental findings are given in IUCLID section "Toxicity to reproduction". - Dose descriptor:
- NOAEL
- Remarks:
- general toxicity
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related adverse effects
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: no treatment-related adverse effects
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 120 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: significantly increased pre-birth loss, prolonged gestation period in high dose females
- Critical effects observed:
- not specified
- Conclusions:
- A combined repeated toxicity study with a reproduction and developmental toxicity study was conducted in Sprague Dawley rats in order to provide information on systemic toxicity (body weight and body weight gain, clinical signs including neurotoxicity assessment, motor activity and sensory reaction to stimuli, food consumption, clinical pathology parameters, organ weights, macroscopic and microscopic examination) as well as any possible effects of the test item on male and female reproductive performance (gonadal function, mating behaviour, conception, development of the conceptus, parturition and early lactation).The dosages were 50, 120 and 300 mg/kg bw/day.
On the basis of the results obtained in the study, the NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered 300 mg/kg bw/day for males and females.
The NOAEL for reproductive and developmental toxicity was considered to be 300 mg/kg bw/day for males and 120 mg/kg bw/day for females and their litters. - Executive summary:
In a combined repeated toxicity study with a reproduction and developmental toxicity study according to OECD Guideline 422 (adopted on 22 March 1996) Tetrahydrofurfuryl methacrylate was administered to 10 Sprague Dawley rats / sex / dose by gavage at dose levels of 0 (control), 50, 120 and 300 mg/kg bw/day in corn oil at a constant volume of 5 mL/kg bw.
Males were treated for a total of 29 days including 2 weeks prior to pairing and continuously thereafter, up to the day before necropsy. Females were dosed throughout the study including 2 weeks before pairing, thereafter during pairing, gestation and lactation periods until the day of necropsy or Day 3 post partum for females with live pups at Day 4 post partum.
The following parameters were evaluated in parental animals: body weight, clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, oestrous cycle, mating performance, clinical pathology investigations (haematology and clinical chemistry), litter data, macroscopic observations, organ weights and histopathological examination. Pup weight, pup clinical signs and pup macroscopic observations were also performed.
No mortality occurred in the study. Observation of animals at removal from the cage and in an open arena (neurotoxicity assessment) did not reveal changes attributable to the test item. No significant clinical signs were observed.
Males
No relevant changes were recorded during the study and at the post mortem examinations in males at any dose level investigated. In particular no effects were seen on body weight and body weight gain,
clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, clinical pathology investigations (haematology and clinical chemistry), macroscopic observations, organ weights and histopathological examination, including identification of the stages of
the spermatogenic cycle. The mating performance including the pre-coital interval (i.e. the number of days paired to sperm positive day) and the copulatory evidence (i.e. the presence of sperm and/or copulation plug in situ or in the cage) did not show differences between groups.
Females
A total of 5 females were found not pregnant at necropsy: 4 in the control group and 1 in the mid-dose (120 mg/kg bw/day) group. Unilateral implantation was observed in one low dose (50 mg/kg bw/day) female. In the high dose group (300 mg/kg bw/day), 3 females had total resorption and 7 females had total litter loss within 1 day of parturition.
Therefore, the number of females with live pups on Day 4 post partum was: 6 in the control, 10 in the low dose (50 mg/kg bw/day), 9 in the mid-dose (120 mg/kg bw/day) group and none in the high dose (300 mg/kg bw/day) group.
On Day 20 post coitum, a decrease in body weight and body weight gain (statistically significant) was evident in females dosed at 300 mg/kg bw/day respect to controls. Decreases in food consumption were seen in high dose females (300 mg/kg bw/day) when compared with controls during the post coitum and post partum periods with statistically significance on Days 7 and 14 post coitum and 4 post partum. Gestation length of all treated groups was higher than controls and significantly increased at statistical analysis, in the high dose group. The pre-birth loss was significantly increased at statistical analysis, in high dose females. This increase could be attributable to the prolonged gestation period which caused most probably pup suffering and the death during or shortly after the birth.
Offspring
An increased presence of missing or dead pups was noted in females receiving 300 mg/kg bw/day. No other treatment-related findings were noted in pups.
At necropsy no treatment-related findings were noted in pups which died or in pups sacrificed on Day 4 post partum.
No difference in sex ratios was noted between the control and treated groups.
No relevant differences in litter data were seen. Decreases in litter weights, seen in low and mid-dose groups were due to the lower number of pups in treated groups respect to control, more evident in mid-dose group in which the increased pup loss was attributed to single females.
On the basis of the results obtained in the study, the NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered 300 mg/kg bw/day for males and females.
The NOAEL for reproductive and developmental toxicity was considered to be 300 mg/kg bw/day for males and 120 mg/kg bw/day for females and their litters.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- OECD guideline 422 study, no deviations, GLP
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For THFMA, a reliable (RL=1), relevant and adequate study is available on repeated dose toxicity:
In a combined repeated toxicity study with a reproduction and developmental toxicity study according to OECD Guideline 422 (adopted on 22 March 1996) Tetrahydrofurfuryl methacrylate was administered to 10 Sprague Dawley rats / sex / dose by gavage at dose levels of 0 (control), 50, 120 and 300 mg/kg bw/day in corn oil at a constant volume of 5 mL/kg bw.
Males were treated for a total of 29 days including 2 weeks prior to pairing and continuously thereafter, up to the day before necropsy. Females were dosed throughout the study including 2 weeks before pairing, thereafter during pairing, gestation and lactation periods until the day of necropsy or Day 3 post partum for females with live pups at Day 4 post partum.
The following parameters were evaluated in parental animals: body weight, clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, oestrous cycle, mating performance, clinical pathology investigations (haematology and clinical chemistry), litter data, macroscopic observations, organ weights and histopathological examination. Pup weight, pup clinical signs and pup macroscopic observations were also performed.
No mortality occurred in the study. Observation of animals at removal from the cage and in an open arena (neurotoxicity assessment) did not reveal changes attributable to the test item. No significant clinical signs were observed.
Males
No relevant changes were recorded during the study and at the post mortem examinations in males at any dose level investigated. In particular no effects were seen on body weight and body weight gain,
clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, clinical pathology investigations (haematology and clinical chemistry), macroscopic observations, organ weights and histopathological examination, including identification of the stages of
the spermatogenic cycle. The mating performance including the pre-coital interval (i.e. the number of days paired to sperm positive day) and the copulatory evidence (i.e. the presence of sperm and/or copulation plug in situ or in the cage) did not show differences between groups.
Females
A total of 5 females were found not pregnant at necropsy: 4 in the control group and 1 in the mid-dose (120 mg/kg bw/day) group. Unilateral implantation was observed in one low dose (50 mg/kg bw/day) female. In the high dose group (300 mg/kg bw/day), 3 females had total resorption and 7 females had total litter loss within 1 day of parturition.
Therefore, the number of females with live pups on Day 4 post partum was: 6 in the control, 10 in the low dose (50 mg/kg bw/day), 9 in the mid-dose (120 mg/kg bw/day) group and none in the high dose (300 mg/kg bw/day) group.
On Day 20 post coitum, a decrease in body weight and body weight gain (statistically significant) was evident in females dosed at 300 mg/kg bw/day respect to controls. Decreases in food consumption were seen in high dose females (300 mg/kg bw/day) when compared with controls during the post coitum and post partum periods with statistically significance on Days 7 and 14 post coitum and 4 post partum. Gestation length of all treated groups was higher than controls and significantly increased at statistical analysis, in the high dose group. The pre-birth loss was significantly increased at statistical analysis, in high dose females. This increase could be attributable to the prolonged gestation period which caused most probably pup suffering and the death during or shortly after the birth.
Offspring
An increased presence of missing or dead pups was noted in females receiving 300 mg/kg bw/day. No other treatment-related findings were noted in pups.
At necropsy no treatment-related findings were noted in pups which died or in pups sacrificed on Day 4 post partum.
No difference in sex ratios was noted between the control and treated groups.
No relevant differences in litter data were seen. Decreases in litter weights, seen in low and mid-dose groups were due to the lower number of pups in treated groups respect to control, more evident in mid-dose group in which the increased pup loss was attributed to single females.
On the basis of the results obtained in the study, the NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered 300 mg/kg bw/day for males and females.
The NOAEL for reproductive and developmental toxicity was considered to be 300 mg/kg bw/day for males and 120 mg/kg bw/day for females and their litters.
There are no data gaps for the endpoint repeated dose toxicity. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.
Justification for classification or non-classification
Based on the available data, THFMA does not need to be classified for repeated dose toxicity according to the criteria given in regulation (EC) 1272/2008. Thus, no labelling is required.
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