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EC number: 202-625-6 | CAS number: 97-99-4
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The key study for skin irritation found the test material not irritating (WIL 1992). It was conducted according to a protocol equivalent to the current OECD guideline, and in compliance with GLP.
The key study for eye irritation found the test substance irritating to the eyes of rabbit, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjuntival chemosis of ≥2 in 3 animals (WIL 1992). The study was reliable and compliant with GLP.
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:
- 7 - 10 October 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Agricultural Chemicals Laws and regulations Testing Guidelines for Toxicology Studies published by the Society of Agricultural Chemical Industry, under the Ministry of Agriculture, Forestry and Fisheries
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton research Products, Inc. Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2638 - 2838 grams
- Housing: Individual suspended mesh - bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 52-62
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6F
- Details on study design:
- TEST SITE
- Area of exposure: the back of rabbits
- Type of wrap if used: gauze patches that were overwrapped with a gauze binder and secured with Dermiform tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with disposable paper towels moistened with deionized water.
- Time after start of exposure:
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material induced very slight erythema in three rabbits. There was no oedema. All erythema completely subsided by day 3 or earlier. There were no other dermal findings.
- Other effects:
- None of the rabbits died. There were no significant body weight changes during the study period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating to the skin of rabbits in a reliable study conducted according to current guideline and in compliance with GLP.
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:
- October 8 - 30, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products Inc., Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2549-3004 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 42-74
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 4 males
2 females - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: UV-light / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- corneal irritation was present in 3 out of 6 animals; irritation reversible by day 21 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- iridal irritation was present in 5 out of 6 animals; irritation reversible by day 7 or earlier
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- minor conjunctival irritation persisted to termination in one animal. Individual animal data are missing
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- individual animal data are missing - Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual animal data are missing
- Remarks:
- Conjunctival irritation assessed by redness scored out of 3; chemosis scored out of 4 and/or discharge scored out of 3 was present in all 6 animals, the reactions were positive for four animals; irritation reversible by day 7 or earlier for five animals; minor conjunctival irritation persisted to termination in one animal
- Irritant / corrosive response data:
- Conjunctival irritation was observed in the treated eye of all animals, including positive reactions for four animals. Iridial and corneal irritation were present in the treated eye of five animals, respectively. All iridial and corneal irritation completely subsided by day 7 and day 21, respectively, or earlier. Conjunctival irritation completely subsided by day 7 or earlier for five rabbits. Minor conjunctival irritation persisted through study termination for one animal.
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance was found irritating to the eyes of rabbit, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjuntival chemosis of ≥2 in 3 animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study for skin irritation found the test material not irritating to the skin of rabbits in a reliable study conducted according to current guideline and in compliance with GLP (WIL 1992). The test material induced very slight erythema in three rabbits. There was no oedema. All erythema completely subsided by Day 3 or earlier. There were no other dermal findings. None of the rabbits died. There were no significant body weight changes during the study period. A reliability 4 supporting study was also available, which supported the key findings (Lashmar et al., 1989).
The key study for eye irritation was conducted according to a protocol equivalent to current OECD guideline, and in compliance with GLP (WIL 1992).Conjunctival irritation was observed in the treated eye of all animals, including positive reactions for four animals. Iridial and corneal irritation were present in the treated eye of five animals, respectively. All iridial and corneal irritation completely subsided by Day 7 and Day 21, respectively, or earlier. Conjunctival irritation completely subsided by Day 7 or earlier for five rabbits. Minor conjunctival irritation persisted through study termination for one animal. The test substance was found to be irritating to the eyes of rabbits, based on corneal opacity of ≥1 in 3 animals, iritis of ≥1 in 4 animals and conjunctival chemosis of ≥2 in 3 animals. Two reliability 4 supporting studies were also available for review, which supported the findings of the key study (Conquet et al., 1976, Jacobs et al., 1988).
Justification for classification or non-classification
Based on the available information, no classification is required for THFA for skin irritation. In accordance with EC Regulation No. 1272/2008, THFA is classified as Category 2: Irritating to eyes, H319: Causes serious eye 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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