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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
- 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
Skin irritation: not irritating; similar to US FHSA Federal regulation: 16 CFR 1500.41; pre-GLP; RL=2; undiluted test material applied to intact and abraded skin sites for 24 h under occlusive dressing; very slight erythema in 2/6 animals, no dermal irritation in 4/6 animals
Eye irritation: not irritating; similar to FHSA Federal regulation: 16 CFR 1500.42; pre-GLP; RL=2; undiluted test material applied to left eye of 6 animals without washing; no effects on cornea and iris, transient conjunctival redness (grade 1-2) in 5/6 animals and chemosis (grade 1) in 2/6 animals, fully reversible within 4 days
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standard. Pre-GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, skin toxicity according to Draize (1959)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US FHSA Federal regulation: 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- DETAILS ON TEST ANIMALS
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: one site shaved/intact + one site shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated control sites on the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as suppplied - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- The test material was applied to two clipped areas on each of six animals, one abraded and one left intact.
- Area of exposure: 2.5 x 2.5 cm
- Coverage ad wrap: Test sites were covered with medical strips which were fixed by leucoplast stripes. Whole animal trunk was wrapped in rubberized impervious cloth to minimize evaporation of the test substance. The animals were immobilized for the 24 hour exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: erythema/eschar and edema scoring similar to OECD guideline 404 - Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritation parameter:
- erythema score
- Remarks:
- inta ct skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- study termination at 72 h, thus, reversibility cannot be evaluated
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h,
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: timepoint
- Remarks:
- no scoring at 48 h
- Irritant / corrosive response data:
- 1/6 animals showed very slight erythema (grade 1) after 24 h, which was fully reversible within 72 h. In 1/6 animals very slight erythema (grade 1) was observed after 24 and 72 h. 4/6 animals showed no skin reactions at all.
Abraded skin:
1/6 animals showed very slight erythema (grade 1) after 24 and 72 h.
The observation time did not extend beyond 72 hours, even though a slight skin response was still present at that time in one animal. Therefore, the full reversibility of the effects can not be proved. However skin effects showed clear tendency of reversibility. At study termination, reversibility was complete in 1/2 affected animals. Therefore, a full reversibility seems to be very likely if the observation period had been extended to the period stipulated in the international guidelines. - Other effects:
- No other effects were reported.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this primary dermal irritation study in rabbit, THFMA is not a dermal irritant.
- Executive summary:
In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of THFMA (according to sponsor's information: purity ca. 98%) to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored similar to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404.
Very slight dermal irritation response was observed in 1/6 animals on intact and abraded skin after 24 and 27 h and in 1/6 animals on intact skin after 24 h. All other animals showed no dermal irritation response.
The observation time did not extend beyond 72 hours, even though a slight skin response was still present at that time in one animal. Therefore, the full reversibility of the effects can not be proved. However skin effects showed clear tendency of reversibility. At study termination, reversibility was complete in 1/2 affected animals. Therefore, a full reversibility seems to be very likely if the observation period had been extended to the period stipulated in the international guidelines.
In this study, THFMA is not a dermal irritant.
Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated.
Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.
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 (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards comparable to international guidelines. Pre-GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in foods, druge and cosmetics, by the Staft of the Division of Pharmacology, US FDA, Bewertung von Augen-Läsionen nach Draize (1959)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US FHSA Federal regulation: 16 CFR 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 45 to 55%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, as supplied - Duration of treatment / exposure:
- eys were not rinsed after application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed for substance removal after treatment
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 7
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days.
- Other effects:
- no other effects reported
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this study, THFMA is not an eye irritant.
- Executive summary:
In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),
0.1 mL of THFMA (according to sponsor's information purity ca. 98%) was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days. No irritating effects to the cornea and iris have been observed.
In this study, THFMA is not an eye irritant.
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 (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable (RL=2), relevant and adequate studies are available to assess the skin and eye irritation potential of THFMA.
Skin irritation
In a primary dermal irritation study similar to US FHSA Federal regulation: 16 CFR 1500.41, 6 rabbits were dermally exposed to 0.5 mL of THFMA (according to sponsor's information: purity ca. 98%) to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored similar to FHSA Federal guideline 16 CFR 1500.41. This scoring system is similar to OECD guideline 404.
Very slight dermal irritation response was observed in 1/6 animals on intact and abraded skin after 24 and 27 h and in 1/6 animals on intact skin after 24 h. All other animals showed no dermal irritation response.
The observation time did not extend beyond 72 hours, even though a slight skin response was still present at that time in one animal. Therefore, the full reversibility of the effects can not be proved. However, skin effects showed clear tendency of reversibility. At study termination, reversibility was complete in 1/2 affected animals. Therefore, a full reversibility seems to be very likely if the observation period had been extended to the period stipulated in the international guidelines.
In this study, THFMA is not a dermal irritant.
Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin is stipulated. Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of guideline US FHSA Federal regulation: 16 CFR 1500.41 will also be not irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore, the study is adequate for C&L purposes.
Eye irritation
In a primary eye irritation study similar to US FHSA Federal regulation: 16 CFR 1500.42 (similar to OECD guideline 405),
0.1 mL of THFMA (according to sponsor's information purity ca. 98%) was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits without removing the test substance. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
Transient conjunctival redness grade 1 (some blood vessels hyperaemic (injected)) to 2 (diffuse, crimson colour; individual vessels not easily discernible) was seen up to 72 h after application in 5/6 animals. Chemosis grade 1 (some swelling above normal) was observed in 2/6 animals. All other animals showed no reactions. All effects were completely reversible within 4 days. No irritating effects to the cornea and iris have been observed.
In this study, THFMA is not an eye irritant.
Respiratory irritation
No data on the respiratory irritation of THFMA are available.
There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results 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 eye irritation or skin irritation according to regulation (EC) 1272/2008 or the former European directive on classification and labelling 67/548/EEC. Thus, no labelling is required.
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