Registration Dossier
Registration Dossier
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EC number: 700-351-6 | CAS number: -
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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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
Skin: The test item was considered to be non-irritating based on a primary irritation index of zero (OECD 404 and EU Method B.4)
Eye: Irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage (OECD 405 and EU Method B.5).
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:
- 28 October 2008 - 08 November 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report
- 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
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino; SPF-quality
- Details on test animals or test system and environmental conditions:
- ANIMALS
- Source: Harlan France SARL, Gannat, France
- Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg
- Identification: Earmark
- Health inspection: A health inspection was performed prior to commencement of treatment to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
ANIMAL HUSBANDRY
- Animals were housed in a controlled environment in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0 °C (acutal range 22.2 to 23.2 °C), a relative humidity of 30 to 70 % (actual range 32 to 64 %) and 12 hours artificial fluorescent light and 12 hours darkness per day.
ACCOMODATION
- Animals were individually housed in labelled cages with perforated floors (Ebeco, Germany) dimensions 67 x 62 x 55 cm and shelters (Ebeco, Germany) dimensions 40 x 32 x 23 cm.
- Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
DIET
- Pelleted diet for rabbits (Global Diet 2030 (irradiated) Mucedola srl, Sellimo Milanese, Italy, supplied by Harlan Netherlands B.V., Horst, The Netherlands approximately 100 g per day plus hay (TecniLab-BMI BV, Someren, The Netherlands) provided at least three times per week.
WATER
- Free access to tap water.
ANALYSIS
- Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Test substance was ground to a powder using a pestle and mortar prior to weighing and the test substance was moistened with water (Elix, Millipore S.A.S, Molsheim, France) immediately before application to ensure close contact with the animal's skin.
- Amount(s) applied (volume or weight with unit): 0.5 grams of test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3 males
- Details on study design:
- STUDY DESIGN
- An in vitro study was considered but a negative result was anticipated and this would need to have been confirmed by an in vivo study.
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel).
- The two other animals were treated in a similar manner one wek later after considering the degree of skin irritation observed in the first animal.
- No histopathology was performed.
TREATMENT
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers exposing an area of approximately 10 x 15 cm (150 cm2).
- To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
- The test substance (0.5 g) was moistened with 0.8 mL of the vehicle and applied to the skin of one flank, using a metalline patch of 2 x3 cm.
- The patch was mounted on a Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
- Four hours after the application, the dressing was removed and the skin cleansed of residual test substance using tap water and watery ethanol (50% v/v).
OBSERVATIONS
- Mortality/viability: Twice daily
- Toxicity: At least once daily
- Body weight: Day of treatment (prior to application) and at termination
- Irritation: The eyes of each animal were examined at approximately 1, 24, 48 and 72 hours after removal of the dressings. Irritation scores according to the attached scheme were recorded together with a description of other (local effects). - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 966
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 26
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 28
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 966
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 26
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 28
- Irritant / corrosive response data:
- - Individual skin irritation scores are presented in Table 1 (attached).
- No skin irritation was caused by exposure to the test item for four hours.
- There was no evidence of a corrosive effect on the skin. - Other effects:
- - Grey/brown staining of the treated skin by the test substance was observed on Day 1 which did not hamper the scoring of the skin reactions. No remnants of the test substance were present on the skin.
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. - Interpretation of results:
- not irritating
- Conclusions:
- The test item was considered to be non-irritating based on a primary irritation index of zero.
- Executive summary:
GUIDELINE
The study was conducted in accordance with OECD No 404 (2002) "Acute Dermal Irritation/Corrosion", EU No Method B.4 (2008) "Acute Toxicity: Dermal Irritation/Corrosion", EPA OPPTS 870.2500 (1998) "Acute Dermal Irritation" and JMAFF guidelines (2000) including the most recent revisions.
METHODS
Three rabbits were exposed to test item (0.5 g) moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers exposing an area of approximately 10 x 15 cm (150 cm2). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations. The test substance (0.5 g) was moistened with 0.8 mL of the vehicle and applied to the skin of one flank, using a metalline patch of 2 x3 cm. The patch was mounted on a Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleansed of residual test substance using tap water and watery ethanol (50% v/v).
RESULTS
No skin irritation was caused by exposure to the test item for four hours. Grey/brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of skin reactions. No remnants of the test substance were present on the skin.
CONCLUSION
The test item was considered to be non-irritating based on a primary irritation index of zero.
- 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:
- 03 November 2008 - 13 November 2008
- Reliability:
- 1 (reliable without restriction)
- 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 OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- 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: Harlan France SARL, Gannat, France.
- Conditions: Controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21 +/- 3C, a relative humididty of 30-70% and 12 hours artificial fluorescent light and 12 hours darkness per day.
- Housing: Individually in labelled cages with perforated floors (Ebeco, Germany) dimensions 67 x 62 x 55 cm and shelters (Ebeco, Germany) dimensions 40 x 32 x 23 cm.
- Acclimatisation: At least five days before the start of treatment under laboratory conditions.
- Diet: Pelleted diet for rabbits (K-H from SSNIFF Spezialdiatenj GmbH, Soest, Germany (approximately 100 g per day) and hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: Free access to tap water.
- Results of analysis for each batch of diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the integrity of the study. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted
- Amount(s) applied (volume or weight with unit): 62.1 mg (range 61.8-62.2 mg) of the test substance (a volume of approximately 0.1 mL)
- Duration of treatment / exposure:
- 72 hours in one animal (sentinel) and 24 hours in the other two animals.
- Observation period (in vivo):
- approximately 1, 24, 48, and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 Males
- Details on study design:
- STUDY DESIGN
- An in vitro study was considered but a negative result was anticipated and this would need to have been confirmed by an in vivo study.
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel).
- The two other animals were treated in a similar manner one wek later after considering the degree of eye irritation observed in the first animal.
TREATMENT
- Animals were treated by instillation of 62.1 to 62.2 mg test substance (0.1 mL) into the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball.
- The lids were then gently held together for about one second to prevent loss of the test substance.
- The other eye remained untreated and served as the reference control.
- Immediately after the 24 -hour observation, a solution of 2 % fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
- Immediately after fluorescein examination on Day 2, the treated eye of two animals was rinsed with tepid tap water (approximately 50 mL) to remove residual test substance using a velocity of flow which did not affect the eye.
- For reference control the other eye was also rinsed.
- After the final observation, the animals were sacrificed by intravenous injection of phenobarbital (Euthesate; Ceva Sante Animale BV, Naaldwijk, The Netherlands).
OBSERVATIONS
- Mortality/viability: Twice daily
- Toxicity: At least once daily
- Body weight: Day of treatment (prior to instillation) and at termination
- Irritation: The eyes of each animal were examined at approximately 1, 24, 48 and 72 hours after instillation of the test substance. Irritation scores according to the attached scheme were recorded together with a description of other (local effects). - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 955
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Animal 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Animal 4
- Irritant / corrosive response data:
- - Individual eye irritation scores are presented in Table 1 (attached).
- Instillation of approximately 62 mg of test item (0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjuntivae (redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours).
- No iridial irritation or corneal opacity was observed and treatment of the eyes with 2 % fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
- There was no evidence of ocular corrosion. - Interpretation of results:
- not irritating
- Conclusions:
- Instillation of approximately 62 mg of test item (a volume of approximately 0.1 mL) into the eye of each of three rabbits resulted in irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Based on these results the test item does not have to be classified for eye irritation according to EC criteria (Council Directive 67/548/EEC) or the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007).
- Executive summary:
GUIDELINE
The study was conducted in accordance with OECD No 405 (2002) "Acute Eye Irritation/Corrosion", EU No Method B.5 (2008) "Acute Toxicity: Eye Irritation/Corrosion", EPA OPPTS 870.2400 (1998) "Acute Eye Irritation" and JMAFF guidelines (2000) including the most recent revisions.
METHODS
Animals were treated by instillation of 62.1 to 62.2 mg test substance (0.1 mL) into the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24 -hour observation, a solution of 2 % fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Immediately after fluorescein examination on Day 2, the treated eye of two animals was rinsed with tepid tap water (approximately 50 mL) to remove residual test substance using a velocity of flow which did not affect the eye. For reference control the other eye was also rinsed. After the final observation, the animals were sacrificed by intravenous injection of phenobarbital.
RESULTS
Instillation of approximately 62 mg of test item (a volume of approximately 0.1 mL) into the eye of each of three rabbits resulted in irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
CONCLUSION
Based on study results the test item does not have to be classified for eye irritation according to EC criteria (Council Directive 67/548/EEC) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007).
- 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
- No staining of (peri) ocular tissues by the test substance was observed. Remnants of the test substance were present in the eye and on the outside of the eyelids in all animals on Day 1. On Day 2, test substance remnants were still present in the eye in two animls and on the outside of the eyelids in one animal.
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A key study was conducted in accordance with OECD No 404 (2002) "Acute Dermal Irritation/Corrosion", EU No Method B.4 (2008) "Acute Toxicity: Dermal Irritation/Corrosion", EPA OPPTS 870.2500 (1998) "Acute Dermal Irritation" and JMAFF guidelines (2000) including the most recent revisions.
Three rabbits were exposed to test item (0.5 g) moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers exposing an area of approximately 10 x 15 cm (150 cm2). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations. The test substance (0.5 g) was moistened with 0.8 mL of the vehicle and applied to the skin of one flank, using a metalline patch of 2 x3 cm. The patch was mounted on a Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleansed of residual test substance using tap water and watery ethanol (50% v/v).
No skin irritation was caused by exposure to the test item for four hours. Grey/brown staining of the treated skin by the test substance was observed on Day 1, which did not hamper the scoring of skin reactions. No remnants of the test substance were present on the skin.
The test item was considered to be non-irritating based on a primary irritation index of zero.
Eye
A key study was conducted in accordance with OECD No 405 (2002) "Acute Eye Irritation/Corrosion", EU No Method B.5 (2008) "Acute Toxicity: Eye Irritation/Corrosion", EPA OPPTS 870.2400 (1998) "Acute Eye Irritation" and JMAFF guidelines (2000) including the most recent revisions.
Animals were treated by instillation of 62.1 to 62.2 mg test substance (0.1 mL) into the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24 -hour observation, a solution of 2 % fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Immediately after fluorescein examination on Day 2, the treated eye of two animals was rinsed with tepid tap water (approximately 50 mL) to remove residual test substance using a velocity of flow which did not affect the eye. For reference control the other eye was also rinsed. After the final observation, the animals were sacrificed by intravenous injection of phenobarbital.
Instillation of approximately 62 mg of test item (a volume of approximately 0.1 mL) into the eye of each of three rabbits resulted in irritation of the conjunctivae which consisted of redness in one animal which resolved within 24 hours and redness and discharge in the other two animals which resolved within 48 hours. No iridial or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Based on study results the test item does not have to be classified for eye irritation according to EC criteria (Council Directive 67/548/EEC) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007).
Justification for classification or non-classification
Skin
The substance does not meet the criteria for classification as an eye irritant under the terms of Regulation No. 1272/2008.
Eye
The substance does not meet the criteria for classification as an eye irritant under the terms of Regulation No. 1272/2008.
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.