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EC number: 201-325-2 | CAS number: 81-11-8
- 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 given test chemical was not irritating to the skin and eyes of the rabbits.
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Skin Irritation study was conducted for the given test chemical.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: adult, nulliparous, nonpregnant, female rabbits
- Weight at study initiation: weighing 3.4, 3.6 and 4.0 kg were used in the study
- Housing: Rabbits were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Animals were fed 100-120 g standard diet per animal/day
- Water (e.g. ad libitum): allowed free access to tap water
- Acclimation period: They were quarantined for at least 14 days before use.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 degrees C
- Humidity (%): 40-70% relative humidity
- Air changes (per hr): 500 lux illumination, 12-15 air exchanges per hour.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 Hours
- Observation period:
- 7 Days
- Number of animals:
- Total = 3
- Details on study design:
- TEST SITE
- Area of exposure: the dorso-lateral area of the trunk
- % coverage: 6 x 6 cm
- Type of wrap if used: hypoallergenic patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): dressings were removed and the exposed skin was carefully washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Method of calculation: Dermal irritation was scored for the degree of erythema/eschar formation according to the method of Draize after 1, 24, 48, and 72 hours and 7 days. Erythema/eschar and edema were each scored on a scale of 0-4 (no effect to severe effect). Any serious lesions or toxic effects other than dermal irritation were recorded. The Draize scores at 24, 48 and 72 hours were added. The total of the three scores was divided by three to give the irritation index. This index was calculated sep arately for erythema/eschar formation and edema. Data interpretation was based on the individual indices of the two most sensitive animals. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test chemical was not irritating to the skin.
- Interpretation of results:
- other: not irritating
- Conclusions:
- The given test chemical was not irritating to the skin.
- Executive summary:
Skin irritation study was performed for the given test chemical as per OECD Guideline 404 (Acute Dermal Irritation / Corrosion) on New Zealand White rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 3.4, 3.6 and 4.0 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. Approximately 24 hours before the test, fur was clipped from the dorso-lateral area of the trunk (6 x 6 cm) of each of the rabbits. Care was taken to avoid abrasion. Pulverized test material (500 mg) was moistened with deionized water and applied to a hypoallergenic patch. An additional patch as moistened only with water. The patches were placed on the opposite dorso-lateral areas of the trunk of each animal. They were held in place with a semiocclusive dressing for 4 hours. The area of exposure was approximately 6 cm2. After 4 hours, dressings were removed and the exposed skin was carefully washed with water. Dermal irritation was scored for the degree of erythema/eschar formation according to the method of Draize after 1, 24, 48, and 72 hours and 7 days. Erythema/eschar and edema were each scored on a scale of 0-4 (no effect to severe effect). Any serious lesions or toxic effects other than dermal irritation were recorded. The Draize scores at 24, 48 and 72 hours were added. The total of the three scores was divided by three to give the irritation index. This index was calculated sep arately for erythema/eschar formation and edema. Data interpretation was based on the individual indices of the two most sensitive animals. All scores were 0. Hence, the given test chemical was not irritating to the skin.
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Eye irritation study was conducted for the given test chemical.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: healthy, adult, nulliparous, nonpregnant, female rabbits
- Weight at study initiation: weighing 2.9, 3.4 and 3.4 kg were used in the study.
- Housing: Rabbits were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Animals were fed 100-120 g standard diet per animal/day
- Water (e.g. ad libitum): allowed free access to tap water
- Acclimation period: They were quarantined for at least 14 days before use.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 degrees C
- Humidity (%): 40-70% relative humidity
- Air changes (per hr): 12-15 air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle 500 lux illumination - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 39 mg
- Duration of treatment / exposure:
- 24 Hours
- Observation period (in vivo):
- 7 Days
- Number of animals or in vitro replicates:
- Total = 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with normal saline 24 hours after treatment
- Time after start of exposure: 24 hours
SCORING SYSTEM: Eye irritation was scored and recorded at 1, 24, 48, and 72 hours and 7 days. The signs of cornea (opacity and area affected), iris (hyperemia, reaction to light), conjunctivae (erythema, chemosis), and discharge were recorded as described by Draize.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Discharge scores
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Swelling scores
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- The given test chemical was Not Irritating to rabbits' eyes.
- Executive summary:
Eye irritation study was conducted for the given test chemical as per OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 2.9, 3.4 and 3.4 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. The lower lid was gently pulled away from the eyeball and a volume of 100 microliters of pulverized test material (approximately 39 mg) was placed into the conjunctival sac of one eye of each of the rabbits. The lids were then gently held together for about 1 second. The other eye remained untreated and served as the control. The treated eye was rinsed with normal saline 24 hours after treatment. Eye irritation was scored and recorded at 1, 24, 48, and 72 hours and 7 days. The signs of cornea (opacity and area affected), iris (hyperemia, reaction to light), conjunctivae (erythema, chemosis), and discharge were recorded as described by Draize. Any serious lesions or toxic effects other than ocular were recorded. Examinations of the cornea, iris and aqueous humor were facilitated using optical instruments (e.g. hand slit lamp). To define epithelial dam age, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after treatment. The eye was then rinsed with normal saline. The eyes were examined under UV light in a darkened room and under diffuse white illumination according to the method of McDonald and Shadduck. This procedure was repeated later if positive effects were noted. Only effects persisting for more than 24 hours were included in the evaluation. The irritation indices/mean irritation indices were calculated for cornea (opacity), iris, and erythema and swelling (chemosis) of the conjunctivae. The interpretation was based on the individual indices obtained from the two most sensitive animals. Conjunctival redness scores of 1 (some blood vessels definitely hyperemic) were observed at 1 and 24 hours in all rabbits and also at 48 hours in one rabbit. Discharge scores of 1 (slightly increased) were observed in 2 rabbits at 1 hour. Swelling scores of 1 (swelling slightly above normal, including nictitating membrane) were observed in 2 rabbits at 1 hour. All other scores were 0. The given test chemical was Not Irritating to rabbits' eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Skin irritation study was performed for the given test chemical as per OECD Guideline 404 (Acute Dermal Irritation / Corrosion) on New Zealand White rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 3.4, 3.6 and 4.0 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. Approximately 24 hours before the test, fur was clipped from the dorso-lateral area of the trunk (6 x 6 cm) of each of the rabbits. Care was taken to avoid abrasion. Pulverized test material (500 mg) was moistened with deionized water and applied to a hypoallergenic patch. An additional patch as moistened only with water. The patches were placed on the opposite dorso-lateral areas of the trunk of each animal. They were held in place with a semiocclusive dressing for 4 hours. The area of exposure was approximately 6 cm2. After 4 hours, dressings were removed and the exposed skin was carefully washed with water. Dermal irritation was scored for the degree of erythema/eschar formation according to the method of Draize after 1, 24, 48, and 72 hours and 7 days. Erythema/eschar and edema were each scored on a scale of 0-4 (no effect to severe effect). Any serious lesions or toxic effects other than dermal irritation were recorded. The Draize scores at 24, 48 and 72 hours were added. The total of the three scores was divided by three to give the irritation index. This index was calculated sep arately for erythema/eschar formation and edema. Data interpretation was based on the individual indices of the two most sensitive animals. All scores were 0. Hence, the given test chemical was not irritating to the skin.
Eye Irritation
Eye irritation study was conducted for the given test chemical as per OECD Guideline 405 (Acute Eye Irritation / Corrosion) on rabbits. Three healthy, adult, nulliparous, nonpregnant, female rabbits (strain HC:NZW) weighing 2.9, 3.4 and 3.4 kg were used in the study. They were quarantined for at least 14 days before use. During this period, pooled feces specimens were examined for Coccidia oocysts. Rabbits were individually housed in stainless steel cages under standardized conventional conditions (21 +/- 1.5 degrees C, 40-70% relative humidity, 12 hour light/dark cycle, 500 lux illumination, 12-15 air exchanges per hour). They were fed 100-120 g standard diet per animal/day and allowed free access to tap water. The animals were examined one day prior to use. Only animals not exhibiting any alterations to skin or eyes were used. The lower lid was gently pulled away from the eyeball and a volume of 100 microliters of pulverized test material (approximately 39 mg) was placed into the conjunctival sac of one eye of each of the rabbits. The lids were then gently held together for about 1 second. The other eye remained untreated and served as the control. The treated eye was rinsed with normal saline 24 hours after treatment. Eye irritation was scored and recorded at 1, 24, 48, and 72 hours and 7 days. The signs of cornea (opacity and area affected), iris (hyperemia, reaction to light), conjunctivae (erythema, chemosis), and discharge were recorded as described by Draize. Any serious lesions or toxic effects other than ocular were recorded. Examinations of the cornea, iris and aqueous humor were facilitated using optical instruments (e.g. hand slit lamp). To define epithelial dam age, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after treatment. The eye was then rinsed with normal saline. The eyes were examined under UV light in a darkened room and under diffuse white illumination according to the method of McDonald and Shadduck. This procedure was repeated later if positive effects were noted. Only effects persisting for more than 24 hours were included in the evaluation. The irritation indices/mean irritation indices were calculated for cornea (opacity), iris, and erythema and swelling (chemosis) of the conjunctivae. The interpretation was based on the individual indices obtained from the two most sensitive animals. Conjunctival redness scores of 1 (some blood vessels definitely hyperemic) were observed at 1 and 24 hours in all rabbits and also at 48 hours in one rabbit. Discharge scores of 1 (slightly increased) were observed in 2 rabbits at 1 hour. Swelling scores of 1 (swelling slightly above normal, including nictitating membrane) were observed in 2 rabbits at 1 hour. All other scores were 0. The given test chemical was Not Irritating to rabbits' eyes.
Justification for classification or non-classification
The given test chemical was not irritating to the skin and eyes of the rabbits. Hence, the given test chemical was not classified for skin and eyes as per CLP criteria.
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