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EC number: 258-964-5 | CAS number: 54079-53-7
- 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 primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.
Eye Irritation:
For the assessment of the eye irritation values, the corresponding stimulus values from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the eyes.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal irritation potential of the test chemical in New Zealand White rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male and female
- Source: no data available
- Age at study initiation:
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: The animals were conventionally kept in single cages under standardized conditions
- Diet (e.g. ad libitum): The diet consisted of a standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ° C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light):dark-light rhythm of 12 hour
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 0,24,48,72hours, 7 and 14 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: back of the ear
- % coverage: no data available
- Type of wrap if used: plaster bandages
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:test sample was washed off with soap and water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 0, 24,48, 72 hours and 7, 14 days
SCORING SYSTEM:
- Method of calculation: The numerical recording of the effects was made by DRAIZE. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no erythema or edema observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- The primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.
- Executive summary:
The dermal irritation potential of the test chemical was assessed in New Zealand White rabbits.2 Albino rabbits (white New Zealand) of both sexes were used with a body weight of about 2.5 to 3.4 kg. The animals were conventionally kept in single cages under standardized conditions.
For the treatment of each animal, 0.5 g of the test sample was applied to a pulp pad and fixed to the hairless inside of a rabbit of 2 rabbits by means of plaster bandages. To better support the patch, a Stilck pulp was formed into a roll and tied into the ear. The exposure duration was 24 hours. Then the test sample was washed off with soap and water. Erythema and edema were observed and scored at 0, 24,48, 72 hours and 7, 14 days. The numerical recording of the effects was made according to DRAIZE.
The primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.
Reference
Table 1: The animal-specific skin reactions and the skin irritation values are as follows:
Rabbit number |
Draize-grade after approximately |
stimulus value |
||||||||||||
0 |
24 |
48 |
72 |
7 |
14 |
E |
(ed) |
|||||||
E |
(ed) |
E |
(ed) |
E |
(ed) |
E |
(ed) |
E |
(ed) |
E |
(ed) |
|||
53 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N |
N |
0 |
0 |
47 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N |
N |
0 |
0 |
E = erythema / scab; (ED) = edema; N = no assessment
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the ocular irritation potential of the test chemical in New Zealand white rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male and female
- Source: no data available
- Age at study initiation:
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: The animals were conventionally kept in single cages under standardized conditions
- Diet (e.g. ad libitum): The diet consisted of a standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:no data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ° C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light):dark-light rhythm of 12 hour - Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- no data available
- Observation period (in vivo):
- 0, 24,48,72 hours and 7 and 14 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: DRAIZE method of scoring
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- For the assessment of the eye irritation values, the corresponding stimulus values from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the eyes.
- Executive summary:
The ocular irritation potential of the test chemical was assessed in New Zealand white rabbits.
2 Albino rabbits (white New Zealand) of both sexes were used with a body weight of about 2.5 to 3.4 kg. The animals were conventionally kept in single cages under standardized conditions. The test chemical was instilled in the eyes of the rabbits and observed for signs of irritation(dose not mentioned).
The eye reactions were observed and scored at 0, 24,48, 72 hours and 7, 14 days. The numerical recording of the effects was made according to DRAIZE.
For the assessment of the eye irritation values, the corresponding stimulus values from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the 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
Various studies have been reviewed to determine the level of dermal irritation caused by the test chemical in living organisms. The results include in vivo experimental data on rabbits, rats for the test chemical. The studies are summarized as follows:
The dermal irritation potential of the test chemical was assessed in New Zealand White rabbits.2 Albino rabbits (white New Zealand) of both sexes were used with a body weight of about
2.5 to 3.4 kg. The animals were conventionally kept in single cages under standardized conditions.
For the treatment of each animal, 0.5 g of the test sample was applied to a pulp pad and fixed to the hairless inside of a rabbit of 2 rabbits by means of plaster bandages. To better support the patch, a Stilck pulp was formed into a roll and tied into the ear. The exposure duration was 24 hours. Then the test sample was washed off with soap and water. Erythema and edema were observed and scored at 0, 24,48, 72 hours and 7, 14 days. The numerical recording of the effects was made according to DRAIZE.
The primary skin irritant / Corrosion effects was on rabbits (Inner surface of the ears) tested. The overall score for erythema and edema formation after 7 days was 0.0 Following the EC Guideline for the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical can to be considered as non-irritating to the skin.
This is supported by a study which was designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures.
5 female young adult, non-pregnant rats were used for the 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 applied directly 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.
A single dose of 200 mg/kg, 1000 mg/kg and 2000 mg/kg body weight of the test item were applied to 1 female animal respectively in the dose range finding study. Since no signs of irritation were observed at the maximum dose of 2000 mg/kg in the test animals, 2 additional animals were tested in the main study with 2000 mg/kg. The animals were applied with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals. Dermal reaction was observed daily for study period of 14 days.
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 female Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
Based on the available results, it can be considered that the test chemical certainly lacks the potential to cause irritation to skin. Hence, it can be considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.
Eye Irritation:
The ocular irritation potential of the test chemical was assessed in New Zealand white rabbits.
2 Albino rabbits (white New Zealand) of both sexes were used with a body weight of about 2.5 to 3.4 kg. The animals were conventionally kept in single cages under standardized conditions. The test chemical was instilled in the eyes of the rabbits and observed for signs of irritation(dose not mentioned).
The eye reactions were observed and scored at 0, 24,48, 72 hours and 7, 14 days. The numerical recording of the effects was made according to DRAIZE.
For the assessment of the eye irritation values, the corresponding stimulus values from the DRAIZE grades were determined at the assessment times 24, 48 and 72 hours, taking into account the type, intensity and temporal course of the findings. No signs of irritation were observed in the rabbit eyes. Following the EC Guideline on the Classification and Labeling of Hazardous Substances and Preparations (July 1983), the test chemical was to be regarded as non-irritating to the eyes.
Based on the available result, it can be considered that the test chemical certainly lacks the potential to cause irritation to eyes. Hence, it can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.
Justification for classification or non-classification
Available studies for the test chemical indicate a possibility that the test chemical lacks the potential to cause irritation to eyes and skin.
Hence, the test chemical can be considered to be not irritating to eyes and skin. It can be further classified under the category "Not Classified" as per CLP Regulation.
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