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EC number: 204-611-5 | CAS number: 123-23-9
- 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
The test item is considered to be a corrosive to the ocular tissue of the rabbit.
The test item is considered to be a corrosive to the skin of the rabbit.
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:
- from 1996-06-04 to 1996-08-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Lot No.: 0998603612
Purity: 59.6 % - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 21.7 °C (66 - 71 °F)
- Humidity (%): 56 - 78
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g / 100 % concentration
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 14 days after removing the gauze
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: the dorsal area of the trunk
- % coverage: approximately 1 inch x 1 inch
- Type of wrap: 1 x 1 inch square 4-ply gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: after 4 hours of exposure; cleaned with wet gauze and then with dry
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours up to 14 days after patch removal
SCORING SYSTEM:
- Method of calculation: Macroscopic Dermal Grading System based on Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- injuries in depth
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings of eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively and apparent necrosis and eschar which were noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit. - Other effects:
- Apparant necrosis in different formations were observed.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- It was determined that the test item corrosive to skin.
- Executive summary:
The potential irritant and/or corrosive effects of the test item were evaluated on the skin of New Zealand White rabbits in a study performed according to OECD 404, EC Regulation 124/92 method B.4 and EPA OPPTS 798.4470. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 14 days following patch removal.
Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings included eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively, and apparent necrosis and eschar which were both noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit.
Reference
As the observed erythema effect were more severe than the scorring scale allows to be classified, an additional score was added M-4 (= 5) which represented the most severely affected areas - injuries in depth. When this score was assigned additionally the type of injuries were described.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1996-06-07 to 1996-08-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Lot No.: 0998603612
Purity: 59.6 % - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 20 °C (67 - 68 °F)
- Humidity (%): 62 - 85
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 % concentration; 0.1 g substance were instilled
- Duration of treatment / exposure:
- Single dosage with no rinse.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 1 female rabbit
- Details on study design:
- The test article was instilled into the conjunctival sac of the right eye of the animal after gently pulling the lower lid away from the eye. Following instillation, the eyelids were gently held together for approximately one second in order to limit test article loss and the animal was returned to its cage. The contralateral eye remained untreated to serve as a control.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 2
- Remarks on result:
- not determinable
- Remarks:
- due to degree of opacity
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 2
- Remarks on result:
- not determinable
- Remarks:
- due to degree of opacity
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival swelling
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival swelling
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: conjunctival swelling
- Irritant / corrosive response data:
- Exposure to the test article produced corneal opacity in the test eye at the 1 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. Iritis was observed in the test eye at the 1 hour scoring interval. Conjunctivitis (redness and swelling) was noted in the test eye at the 1 hour scoring interval. Additional ocular findings of blanching of nictating membrane, blanching of conjunctival tissue, ocular discharge-yellow and head tilt were noted in the test eye. Due to the severe irritation noted, the animal was euthanized following the 72 hour score.
No corneal opacity, iritis or conjunctivitis was observed in the control eyes. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the initial rabbit dosed, the test item is considered to be a corrosive to the ocular tissue of the rabbit.
- Executive summary:
The potential irritant and/or corrosive effects of the test item were evaluated on the eyes of New Zealand White rabbits. One rabbit received a 0.1000 g (0.1 mL weight equivalent) dose of the test item in the conjunctival sac of the right eye. The contralateral eye of the animal remained untreated and served as a control. The test and control eye was examined for signs of irritation for up to 72 hours following dosing. Due to the amount of irritation noted in the initial rabbit, the remaining animals were not dosed.
Exposure to the test article produced corneal opacity in the test eye at the 1 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. Iritis was observed in the test eye at the 1 hour scoring interval. Conjunctivitis (redness and swelling) was noted in the test eye at the 1 hour scoring interval. Additional ocular findings of blanching of nictating membrane, blanching of conjunctival tissue, ocular discharge-yellow and head tilt were noted in the test eye. Due to the severe irritation noted, the animal was euthanized following the 72 hour score.
Based on the initial rabbit dosed, the test item is considered to be a corrosive to the ocular tissue of the rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation
The potential irritant and/or corrosive effects of the test item were evaluated on the eyes of New Zealand White rabbits. One rabbit received a 0.1000 g (0.1 mL weight equivalent) dose of the test item in the conjunctival sac of the right eye. The contralateral eye of the animal remained untreated and served as a control. The test and control eye was examined for signs of irritation for up to 72 hours following dosing. Due to the amount of irritation noted in the initial rabbit, the remaining animals were not dosed.
Exposure to the test article produced corneal opacity in the test eye at the 1 hour scoring interval. The corneal injury was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. Iritis was observed in the test eye at the 1 hour scoring interval. Conjunctivitis (redness and swelling) was noted in the test eye at the 1 hour scoring interval. Additional ocular findings of blanching of nictating membrane, blanching of conjunctival tissue, ocular discharge-yellow and head tilt were noted in the test eye. Due to the severe irritation noted, the animal was euthanized following the 72 hour score.
Based on the initial rabbit dosed, the test item is considered to be a corrosive to the ocular tissue of the rabbit.
Skin corrosion
The potential irritant and/or corrosive effects of the test item were evaluated on the skin of New Zealand White rabbits in a study performed according to OECD 404, EC Regulation 124/92 method B.4 and EPA OPPTS 798.4470. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 14 days following patch removal.
Exposure to the test article produced moderate edema and moderate to severe blanching on 6/6 test sites at the 1 hour scoring interval. Additional dermal findings included eschar exfoliation and desquamation which were noted on 4/6 and 5/6 test sites, respectively, and apparent necrosis and eschar which were both noted on 6/6 test sites. The dermal irritation resolved completely in 1/6 animals by study day 14.
Under the conditions of this test, the test item is considered to be a corrosive to the skin of the rabbit.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is classified as corrosive to skin Cat 1 (H314) and eye damaging Cat 1 (H318) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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