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EC number: 614-657-1 | CAS number: 68609-08-5
- 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:
The test item was tested for skin irritation in albino New Zealand white rabbits according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion). The results showed very slight to well defined erythema. No edema was observed during the study. The irritation signs decreased completely during the observation period and were evaluated as fully reversible alterations.
Eye irritation:
The test item was tested for eye irritation properties in albino New Zealand white rabbits according to EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion). The results showed moderate conjunctival redness, slight to moderate chemosis and moderate to severely increased discharge excretion in all animals. All signs of irritation decreased during the observation period.
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 2007-10-03 to 2007-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1988
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 2834 - 3389 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received as tap water from self-service water system ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: None
VEHICLE
- Amount(s): None - Duration of treatment / exposure:
- 4 hr
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours, then one week after the patch removal.
- Number of animals:
- 3 Male
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² of intact skin
- % coverage: Not estimated
- Type of wrap if used: Plastic wrap for 4 hrs
REMOVAL OF TEST SUBSTANCE
- Washing: Water of body temperature
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize (1959) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 9143/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 9135/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 9139/M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 9143/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 9135/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 9139/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema in two animals (score 1), well defined erythema (score 2) in one animal. No oedema in all animals. No irritation symptoms /erythema, oedema, and/or other signs)) were observed after 1 week. Study was terminated one week after treatment.
- Other effects:
- no other effects observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was tested for skin irritation in rabbits. The observed symptoms were evaluated as fully reversible alterations.
- Executive summary:
In this skin irritation study albino New Zealand White rabbits were treated with the test item. The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one week after the patch removal.
One hour after the patch removal in two animals very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. There was no oedema observed during the study.
24 hours after the patch removal the degree of erythema did not change compared to the previous observation.
48 hours after the patch removal very slight erythema (scores 1-1-1) was found in all animals.
72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.
1 week after the patch removal, no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals. Thus, one week after the treatment the study was terminated.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:
- erythema: 1.00, 1.00, 1.33
- oedema: 0.00, 0.00, 0.00
During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
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:
- from 2007-10-03 to 2007-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 3126 - 3240 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received tap water from self-service water system ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes: 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g
VEHICLE
- None - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 1, 24, 48, 72 hrs, one week
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not applied
SCORING SYSTEM: Draize 1959
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 9103/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 9111/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 9175/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 9103/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 9111/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 9175/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- 9103/M
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- 9111/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- 9175/M
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.31
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 9103/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 9111/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 9175/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal #1
- Remarks:
- 9103/M
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal #2
- Remarks:
- 9111/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal #3
- Remarks:
- 9175/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- No other effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item, applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week.
- Executive summary:
The acute eye irritation study of the test item was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application.
One hour after the application of the test item into the eyes of rabbits moderate conjunctival redness, slight to moderate chemosis and moderate to severely increased discharge excretion. In one animal diffuse areas of opacity were observed on whole surface of cornea. Iris alterations were not recorded throughout the study.
72 hours after the application in two cases slight redness was found. In above mentioned animal the degree and extension of opacity density did not change to the previous observations. One animal became symptom-free at this time.
One week after treatment the study was terminated, as all animals were free of symptoms of irritation.
The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
- cornea opacity: 1.00, 0.00, 0.00
- iris: 0.00, 0.00, 0.00
- conjunctival redness: 1.67, 1.00, 1.33
- conjunctival chemosis: 1.00, 0.00, 0.00
- conjunctival discharge: 0.67, 0.00, 0.00
The test item, applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a skin irritation study albino New Zealand White rabbits were treated with the test item. The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one week after the patch removal. One hour after the patch removal in two animals very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. There was no edema observed during the study. 24 hours after the patch removal the degree of erythema did not change compared to the previous observation. 48 hours after the patch removal very slight erythema (scores 1-1-1) was found in all animals. 72 hours after the patch removal the irritation symptoms did not change compared to the previous observation. 1 week after the patch removal, no irritation symptoms (erythema, edema and/or other signs) were observed in any of the animals. Thus, one week after the treatment the study was terminated. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:
- erythema: 1, 1, 1.33
- edema: 0, 0, 0
During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period.
Eye irritation
The acute eye irritation study of the test item was performed in three albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 g of the test item, administered in pure state, in single dose. The eyes were examined at 1, 24, 48, 72 hours and one week after application. One hour after the application of the test item into the eyes of rabbits moderate conjunctival redness, slight to moderate chemosis and moderate to severely increased discharge excretion. In one animal diffuse areas of opacity were observed on whole surface of cornea. Iris alterations were not recorded throughout the study. 72 hours after the application in two cases slight redness was found. In above mentioned animal the degree and extension of opacity density did not change to the previous observations. One animal became symptom-free at this time. One week after treatment the study was terminated, as all animals were free of symptoms of irritation. The general state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period. The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
- cornea opacity: 1, 0, 0
- iris: 0, 0, 0
- conjunctival redness: 1.67, 1.00, 1.33
- conjunctival chemosis: 1.00, 0, 0
- conjunctival discharge: 0.67, 0, 0
The test item, applied to the rabbits' eye mucosa, caused slight to severe conjunctival irritant effects and in one case slight corneal alteration, which were fully reversible within one week. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
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 not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
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