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EC number: 947-603-3 | 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
- 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 chemical was assessed for primary irritation to the skin of rabbits according to the Ecological and Toxicological Association of Dyestuffs Manufacturers (ETAD) test based upon the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41.
Under the test conditions employed, the test chemical produced a Primary Irritation Index within the range 0.0 - 0.5 and was thus classified 'non-irritant' to skin.
Eye irritation:
Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Weight of evidence approach based on the available data of the read-across chemicals.
- Justification for type of information:
- Weight of evidence approach based on the available data of the read-across chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on skin irritation study for read across chemicals.
- GLP compliance:
- not specified
- Species:
- other: 2. Rabbit 3. Rat
- Strain:
- other: 2. New Zealand White 3.Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- 2. TEST ANIMALS
- Sex: male
- Weight at study initiation: 2.5 - 3.5 kg bodyweight
- Housing:were housed individually in suspended galvanized and stainless steel cages (from Cope
and Cope Ltd.), measuring 0.6 x 0.6 x 0.4 m high and fitted with mesh floors and automatic watering
- Diet (e.g. ad libitum): complete pelleted rabbit diet; Diet RAG modified, from Labsure Animal Foods,
Poole, Dorset; ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period:All rabbits were held for a minimum period of seven days before entering the
study.
- Identification: Each animal was weighed and allocated by random selection to the appropriate test
group, in which it was identified by numbered ear-tag.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was controlled within the range 15 0 ± 2 0 C
- Photoperiod (hrs dark / hrs light):lighting was restricted to 14 hours in each period of 24 hours
3. - Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight ranges of approximately 239.1 to 272.5 grams at initiation of
dosing were used.
Body weights at the start :
Male
Mean : 269.94 g (= 100 %)
Minimum : 266.4 g (- 1.31 %)
Maximum : 272.5 g (+ 0.95 %)
Total No. of animals : 5
Female
Mean : 244.56 g (= 100 %)
Minimum : 239.1 g (- 2.23 %)
Maximum : 250.4 g (+ 2.39 %)
Total No. of animals : 5
- Fasting period before study: No data
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad
libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages.
All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.3 degree centigrade.
- Humidity (%): 55.7% to 59.6%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to
the room.
IN-LIFE DATES: 30-09-2016 to 15-10-2016 - Type of coverage:
- other: 2. occlusive 3. semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 2. 0.5 g moistened with water
3. TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): No
VEHICLE
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data
POSITIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data - Duration of treatment / exposure:
- 2. 24 hours
3. 24 hours - Observation period:
- 2. 24,48 and 72 hours
3. 14 days - Number of animals:
- 2. 6
3. 10 (5/sex) - Details on study design:
- 2. TEST SITE
- Area of exposure: back
- % coverage: a square patch of surgical gauze measuring 2.5 cm x 2.5 cm
- Type of wrap if used: The entire trunk of the animal is then wrapped with an impervious material
such as rubber or PVC (after ensuring that the test substance does not react chemically with the
rubber or PVC)
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize method
3. TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.
OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability: Twice daily.
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observati
ons were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily ther
eafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, re
spiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7
and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all
the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the
study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was
performed. - Irritation parameter:
- overall irritation score
- Remarks:
- 2
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Remarks:
- 2
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- 3.
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3.
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 2. No responses were detected and a Primary Irritation Index of zero was obtained
3. Overall result:
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during
the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during
the study period of 14 days. - Other effects:
- 3. Clinical Signs of Mortality
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.69% a
nd 16.50% respectively.
Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.02% a
nd 9.12% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose
group. - Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical was assessed for primary irritation to the skin of rabbits according to the Ecological and Toxicological Association of Dyestuffs Manufacturers (ETAD) test based upon the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41. Under the test conditions employed, the test chemical produced a Primary Irritation Index within the range 0.0 - 0.5 and was thus classified 'non-irritant' to skin.
- Executive summary:
A study was conducted according to the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41 to predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit. 6 albino male New Zealand White rabbits were used for the study. The rabbits were fed standard pelleted rabbit diet and water, ad libitum and housed in metal cages throughout the study. Before intended application, both sides of the back were clipped as close to the skin as possible using electric clippers (chemical depilatories were not used). Two to three hours later, abrasions were made to the upper third of one side of the back (flank area behind the ribs). The abrasions were made by using the back of the point of a scalpel blade to scratch a 5 x 5 lattice in an area measuring 2.5cm2 , such that only the stratum corneum was penetrated and bleeding did not occur. 0.5 g of powder were prepared as a paste by addition of a minimal volume of water.One application is made to the skin area previously abraded and one application is made to the intact skin in the corresponding position on the other side of the back. The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC) for the 24-hour period of exposure. The animal was not immobilised but the patches are held in place using bandages or elasticated stockingette. After the 24-hour exposure, the patches are removed and the reactions evaluated without washing the application site The dermal reactions were observed and scored at 24,48 and 72 hours according to the method of Draize. No responses were detected and a Primary Irritation Index of zero was obtained.It was thus classified under the category "Not Classified".
Another study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Weight of evidence approach based on the available data of the read-across chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on eye irritation study for read across chemicals.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: 2. New Zealand White 3. Not specified
- Details on test animals or tissues and environmental conditions:
- 2. TEST ANIMALS
- Sex: male
- Weight at study initiation: 2.5 - 3.5 kg bodyweight
- Housing:were housed individually in suspended galvanized and stainless steel cages (from Cope
and Cope Ltd.), measuring 0.6 x 0.6 x 0.4 m high and fitted with mesh floors and automatic watering
- Diet (e.g. ad libitum): complete pelleted rabbit diet; Diet RAG modified, from Labsure Animal Foods,
Poole, Dorset; ad libitum
- Water (e.g. ad libitum): water; ad libitum
- Acclimation period:All rabbits were held for a minimum period of seven days before entering the
study.
- Identification: Each animal was weighed and allocated by random selection to the appropriate test
group, in which it was identified by numbered ear-tag.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was controlled within the range 15 0 ± 2 0 C
- Photoperiod (hrs dark / hrs light):lighting was restricted to 14 hours in each period of 24 hours
3. No data available - Vehicle:
- other: 2. unchanged (no vehicle) 3.Not specified
- Controls:
- yes, concurrent no treatment
- not specified
- Amount / concentration applied:
- 2. 100mg
3. 0.1 ml of 1.0% aqueous solution - Duration of treatment / exposure:
- 2. single exposure
3. No data available - Observation period (in vivo):
- 2. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours
and 72 hours after instillation
3. No data available - Duration of post- treatment incubation (in vitro):
- 2. no data available
3. No data available - Number of animals or in vitro replicates:
- 2. 6 male rabbits
3. No data available - Details on study design:
- 2. REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: The treated eyes were not washed after instillation of the test chemical
SCORING SYSTEM: Draize method for scoring of ocular lesions
3. No data available - Irritation parameter:
- overall irritation score
- Remarks:
- 2.
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.6
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Not specified
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 2. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation
Score of 2.6. - Interpretation of results:
- other: Not Irritating
- Conclusions:
- Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits.The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation
Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes. - Executive summary:
A study was performed according to method described in the 'Code of Federal Regulations', Title 16, Section 1500.42 to predict the potential for damage to the conjunctiva, cornea and iris in a single exposure of the given test chemical for indeterminate duration in the rabbit. 100 mg of the undiluted test chemical was instilled into the left eye of 6 male New Zealand White rabbits. The untreated eyes served as controls.The treated eyes remained unwashed throughout the study. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours and 72 hours after instillation.The eyes were also evaluated for Pain upon instillation of the test chemical. The ocular reactions were graded according to the method of Draize. For each animal, the scores for the cornea, iris and conjunctiva were added for each of the 24, 48 and 72 hour time periods to give a total score/animal/time period. Then the total scores so obtained were added together and divided by 18.The resultant value was the Irritation Score. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes.
Test chemical was used as test material to evaluate eye irritation potential on rabbit.The test chemical was subjected to rabbit eye in the concentration 0.1 ml1.0% aqueous solution .No ocular reaction was observed .Hence , the test chemical was considered to be not eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation:
A study was conducted according to the method described in the 'Code of Federal Regulations', Title 15, Section 1500.41 to predict the potential for inflammatory or corrosive activity in single, occluded, primary contact of the test chemical with the skin of the rabbit. 6 albino male New Zealand White rabbits were used for the study. The rabbits were fed standard pelleted rabbit diet and water, ad libitum and housed in metal cages throughout the study. Before intended application, both sides of the back were clipped as close to the skin as possible using electric clippers (chemical depilatories were not used). Two to three hours later, abrasions were made to the upper third of one side of the back (flank area behind the ribs). The abrasions were made by using the back of the point of a scalpel blade to scratch a 5 x 5 lattice in an area measuring 2.5cm2 , such that only the stratum corneum was penetrated and bleeding did not occur. 0.5 g of powder were prepared as a paste by addition of a minimal volume of water.One application is made to the skin area previously abraded and one application is made to the intact skin in the corresponding position on the other side of the back. The entire trunk of the animal is then wrapped with an impervious material such as rubber or PVC (after ensuring that the test substance does not react chemically with the rubber or PVC) for the 24-hour period of exposure. The animal was not immobilised but the patches are held in place using bandages or elasticated stockingette. After the 24-hour exposure, the patches are removed and the reactions evaluated without washing the application site The dermal reactions were observed and scored at 24,48 and 72 hours according to the method of Draize. No responses were detected and a Primary Irritation Index of zero was obtained.It was thus classified under the category "Not Classified".
Another study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
Eye Irritation:
A study was performed according to method described in the 'Code of Federal Regulations', Title 16, Section 1500.42 to predict the potential for damage to the conjunctiva, cornea and iris in a single exposure of the given test chemical for indeterminate duration in the rabbit. 100 mg of the undiluted test chemical was instilled into the left eye of 6 male New Zealand White rabbits. The untreated eyes served as controls.The treated eyes remained unwashed throughout the study. The eyes were examined and the grades of ocular reaction were graded at 1 hour, 24 hours, 48 hours and 72 hours after instillation.The eyes were also evaluated for Pain upon instillation of the test chemical. The ocular reactions were graded according to the method of Draize. For each animal, the scores for the cornea, iris and conjunctiva were added for each of the 24, 48 and 72 hour time periods to give a total score/animal/time period. Then the total scores so obtained were added together and divided by 18.The resultant value was the Irritation Score. Single ocular instillation of test chemical, without rinse, into the conjunctival sac resulted in immediate pain reactions varying from practically no initial pain i.e. a few blinks only in one animal, to moderate initial pain in two animals with rubbing of eyes with paws. Three rabbits presented an intermediate response with reflex closure of the eyes without rubbing. Subsequent eye irritation consisted of occasional minor redness and chemosis of the conjunctiva up to 24 hours after treatment in five rabbits. The sixth animal showed greater irritation, with initial discharge at one hour, grade 2 chemosis up to 48 hours, persistent grade 1 conjunctival redness to Day 7 and corneal opacity for four days, never exceeding one-half the total area and clearing by Day 7. These responses resulted in an Irritation Score of 2.6. Hence, based on the observations and scores, it was considered to be not irritating to rabbit eyes.
in another study, Test chemical was used as test material to evaluate eye irritation potential on rabbit.The test chemical was subjected to rabbit eye in the concentration 0.1 ml1.0% aqueous solution .No ocular reaction was observed .Hence , the test chemical was considered to be not eye irritant.
Justification for classification or non-classification
Based on the available in-vivo data for the test chemical, it can be concluded that the test chemical was considered to be not irritating to skin and eyes. Thus it can be considered as “Not classified” for skin and 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.
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