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EC number: 200-607-2 | CAS number: 65-31-6
- 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
Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated 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
Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
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:
- data from handbook or collection of data
- Remarks:
- Weigth of evidence approach based on various test chemicals
- Justification for type of information:
- Weigth of evidence approach based on various test 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:
- Weight of evidence approach based on test chemicals. The study 2,3 are mentioned as study 1,2
- GLP compliance:
- not specified
- Species:
- other: humans
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Controls:
- not specified
- Amount / concentration applied:
- 1. 5%.
2. 1% - Duration of treatment / exposure:
- single exposure
- Observation period:
- 20 minutes
- Number of animals:
- 1. 14 patients
2. 14 patients - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 20 minutes
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of dermal irritation were observed
- Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated 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”.
- Executive summary:
Various studies have been summarized to ascertain the degree of dermal irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans for the test chemicals.
The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical.
The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%.
The skin reactions were assessed 20min after application from 0 to +++.
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.
Equivocal reaction was observed in 1 out of 14 treated patients. Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
This is supported by the results of the skin irritation study conducted on 14 patients to determine the skin irritation potential of test chemical.
The test chemical was applied on the skin of ventral forearm of each subject at concentration of 1%.
The skin reactions were assessed 20min after application from 0 to +++.
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.
Only 1 treated patient showed slight erythema.
Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated to be not irritating to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
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
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals. The study 2,3 are referred as study 1, 2
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 1. undiluted
2. 100 mg - Duration of treatment / exposure:
- 1. 24 hours
2. no data available - Observation period (in vivo):
- 1. 24 hours
2. 1,24,48,72 hours and 7 days - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1. 6
2. 3 - Details on study design:
- The study is based on weight of evidence approach from the read across values
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Signs of irritation were observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
- Executive summary:
Various studies have been summarized to ascertain the degree of ocular irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on rabbitsfor the test chemicals.
The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines .Undiluted test chemical was instilled in to the eyes of New Zealand White rabbits. The eyes were observed for signs of irritation and scored after 24 hours of exposure. After 24 hours the maximum scores was 4.67 (mean cumulative score). The Primary irritation index of the test chemical was 4.17.
Based on these scores, the test chemical was considered to be moderately irritating to eyes.
This is supported by the experimental study performed according to OECD 405 Guidelines to assess the ocular irritation of the test chemical. Single application of ca. 100 mg was instilled in the right eye of 3 female New Zealand White rabbits. The rabbits were observed for signs of irritation and scored at 1,24,48,72 hours and 7 days. Severe discharge and dulling of the normal lustre of the corneal surface of the rabbit eyes were observed. At 72 h effects are still seen in animal 3 and animal 3 was killed for humane reasons on day 7.
Hence, the test chemical was considered to be irritating to the eyes of New Zealand White rabbits.
Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Various studies have been summarized to ascertain the degree of dermal irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans for the test chemicals.
The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical.
The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%.
The skin reactions were assessed 20min after application from 0 to +++.
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.
Equivocal reaction was observed in 1 out of 14 treated patients. Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
This is supported by the results of the skin irritation study conducted on 14 patients to determine the skin irritation potential of test chemical.
The test chemical was applied on the skin of ventral forearm of each subject at concentration of 1%.
The skin reactions were assessed 20min after application from 0 to +++.
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.
Only 1 treated patient showed slight erythema.
Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.
Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be estimated 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
Various studies have been summarized to ascertain the degree of ocular irritation caused by test chemical in living organisms. These results include in vivo experimental studies performed on rabbits for the test chemicals.
The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines .Undiluted test chemical was instilled in to the eyes of New Zealand White rabbits. The eyes were observed for signs of irritation and scored after 24 hours of exposure. After 24 hours the maximum scores was 4.67 (mean cumulative score). The Primary irritation index of the test chemical was 4.17.
Based on these scores, the test chemical was considered to be moderately irritating to eyes.
This is supported by the experimental study performed according to OECD 405 Guidelines to assess the ocular irritation of the test chemical. Single application of ca. 100 mg was instilled in the right eye of 3 female New Zealand White rabbits. The rabbits were observed for signs of irritation and scored at 1,24,48,72 hours and 7 days. Severe discharge and dulling of the normal lustre of the corneal surface of the rabbit eyes were observed. At 72 h effects are still seen in animal 3 and animal 3 was killed for humane reasons on day 7.
Hence, the test chemical was considered to be irritating to the eyes of New Zealand White rabbits.
Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
Justification for classification or non-classification
The results of the experimental studies from the various test chemicals indicate a possibility that the test chemical can be not irritating to skin.
Hence, by applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. It can be classified under the category “Not Classified” as per CLP regulation.
Based on the available data and applying the weight of evidence approach, the test chemical was estimated to cause irritation to eyes. Hence, the test chemical can be considered to be irritating to eyes. It can be further classified under the category “Category 2” as per CLP regulation.
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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