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EC number: 238-942-1 | CAS number: 14871-79-5
- 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 for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, it was considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for skin irritation.
Eye irritation
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, it was considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.
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:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from 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:
- WoE report is based on 2 skin irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on rabbits to assess its skin irritating effects. - GLP compliance:
- no
- Species:
- other: 2. rabbit 3. Human
- Strain:
- other: 2. New Zealand White 3. Not applicable
- Details on test animals or test system and environmental conditions:
- 2. - Age at study initiation: adult
3. No data available - Type of coverage:
- other: 2. occlusive 3. not specified
- Preparation of test site:
- other: 2. shaved (intact or abraded sites) 3. not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 2. 500 mg
3. No data available - Duration of treatment / exposure:
- 2. 4 hours
3. No data available - Observation period:
- 2. 24, 48 and 72 hours
3. No data available - Number of animals:
- 2. 6 (3 males and 3 females)
3. No data available - Details on study design:
- 2. - Area of exposure: shaved backs
SCORING SYSTEM: According to the criteria laid down in EC regulation 1272/2008/EC
3. No data available - Irritation parameter:
- overall irritation score
- Remarks:
- Erythema and edema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 3
- Irritant / corrosive response data:
- 2. A slight erythema (scoring value 1) was observed in all animals at the 24-hour reading and was still persistent in 1 out of 3 animals treated onto an intact skin and 2 out of 3 animals treated on an abraded area at the 72-hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72-hour reading.
3. No skin irritation was observed in treated humans. - Other effects:
- No data
- Interpretation of results:
- other: Not irritating
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for skin irritation.
- Executive summary:
In different studies, the given test chemical has been investigated for the dermal irritation potential to a greater or lesser extent. The studies are summarized as below -
The dermal irritation test was conducted to determine the skin irritation potential of the given test chemical in adult New Zealand white rabbits (3 males and 3 females) using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. the test method used was comparable to the OECD 404 guideline issued in 1981. During the study, the rabbits were dermally exposed to 500 mg of test chemical for 4 hours on prepared shaved backs. 3 animals received the test chemical onto an intact skin while the remaining received the test chemical onto an abraded area. The test substance was held in contact with the skin by means of an occlusive dressing. Cutaneous reactions were observed 24, 48 and 72 hours after removal of the dressing. The test substance caused slight erythema (scoring value 1) in all animals at the 24-hour reading and was still persistent in 1 out 3 animals treated onto an intact skin and 2 out 3 animals treated on an abraded area at the 72-hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72-hour reading. Thus, according to the criteria laid down in EC regulation 1272/2008/EC and based on the observations, the test chemical was considered as non-irritant to the skin.
The above study was supported with another skin irritation test performed to determine skin irritation potential of the given test chemical. There was no evidence of skin irritation, when the chemical was applied dermally on human skin. Thus, the test chemical was considered to be not irritating to the skin of humans.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was considered to be not irritating to skin. Thus it cannot be classified for skin irritation.
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:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from 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:
- WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3.
Eye irritation study of test chemical was conducted rabbits to assess its eye irritating effects. - GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: 2. not specified 3. Himalayan
- Details on test animals or tissues and environmental conditions:
- 2. not specified
3. TEST ANIMALS
- Age at study initiation:4.5 to 5.5 months old
-Weight at study initiation:2.4 to 2.5 kg body weight - Vehicle:
- not specified
- Controls:
- other: 2. The other untreated eye served as control. 3. The left untreated eye served as control
- Amount / concentration applied:
- 2. 100 mg
3. 100mg - Duration of treatment / exposure:
- 2. 72 hours
3. 1 hours - Observation period (in vivo):
- 2. 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions.
3. 24 hours - Number of animals or in vitro replicates:
- 2. 3 (Male/female)
3. Total = 3 - Details on study design:
- 2. TEST SITE
- Area of exposure: one eye
REMOVAL OF TEST SUBSTANCE
- Washing (if done): For 6 rabbits, the eyes were not rinsed after administration of the test item while a washing procedure was applied for 3 other animals.
3. TEST SITE
- Area of exposure: conjunctival sac of the right of each rabbit
REMOVAL OF TEST SUBSTANCE
- Washing (if done): One hour after the instillation the eyes were rinsed with 20 ml aqueous (0.9%) sodium chloride solution. - Irritation parameter:
- chemosis score
- Remarks:
- For rinsed eye
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- For rinsed eye
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.89
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 2
- Irritation parameter:
- iris score
- Remarks:
- For rinsed eye
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- For rinsed eye
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Remarks:
- 3
- Irritant / corrosive response data:
- 2. For rinsed eye : 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively.
3. One hour after the instillation the conjunctiva in all animals was reddened. This hyperaemic reaction was reversible after 24 hours. The cornea and iris were not affected. Systemic intolerance reactions were not observed. - Other effects:
- 2. not specified
3. No data - Interpretation of results:
- other: Not irritating
- Conclusions:
- Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.
- Executive summary:
The ocular irritation potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
An acute ocular irritation study was conducted for the given test chemical to determine the potential to induce eye irritation in 9 rabbits according to methods similar to OPPTS 870.2400 and OECD 405 guidelines. During the study, a single dose of 100 mg of the test chemical was instilled into one eye, the other eye was not treated and served as control. For 6 rabbits, the eyes were not rinsed after administration of the test chemical while a washing procedure was applied for 3 other animals. Ocular reactions were observed 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal. Mean scores calculated over 24, 48 and 72 hours for the 6 animals without rinsing were 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively. Washing procedure did not change the ocular reactions. Thus, under these experimental conditions, test chemical was considered as non-irritant when administered by ocular route to rabbits.
The above study was supported by the results of an eye irritation study conducted to determine the irritation potential of the test chemical on 3 Himalayan rabbits. In a study, 100 mg of test chemical was instilled into the conjunctival sac of the right eye of 3 Himalayan rabbits (4.5 to 5.5 months old; 2.4 to 2.5 kg body weight). One hour after the instillation the eyes were rinsed with 20 ml aqueous (0.9%) sodium chloride solution. The left eye served as control. One hour after the instillation the conjunctiva in all animals was reddened. This hyperaemic reaction was reversible after 24 hours. The cornea and iris were not affected. Systemic intolerance reactions were not observed. Since the observed effects were reversible within 24 hours, the chemical was considered as not irritating to the eyes.
Based on the available data, it can be concluded that the given test chemical cannot cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In different studies, the given test chemical has been investigated for the dermal irritation potential to a greater or lesser extent. The studies are summarized as below -
The dermal irritation test was conducted to determine the skin irritation potential of the given test chemical in adult New Zealand white rabbits (3 males and 3 females) using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. the test method used was comparable to the OECD 404 guideline issued in 1981. During the study, the rabbits were dermally exposed to 500 mg of test chemical for 4 hours on prepared shaved backs. 3 animals received the test chemical onto an intact skin while the remaining received the test chemical onto an abraded area. The test substance was held in contact with the skin by means of an occlusive dressing. Cutaneous reactions were observed 24, 48 and 72 hours after removal of the dressing. The test substance caused slight erythema (scoring value 1) in all animals at the 24-hour reading and was still persistent in 1 out 3 animals treated onto an intact skin and 2 out 3 animals treated on an abraded area at the 72-hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72-hour reading. Thus, according to the criteria laid down in EC regulation 1272/2008/EC and based on the observations, the test chemical was considered as non-irritant to the skin.
The above study was supported with another skin irritation test performed to determine skin irritation potential of the given test chemical. There was no evidence of skin irritation, when the chemical was applied dermally on human skin. Thus, the test chemical was considered to be not irritating to the skin of humans.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also behave in similar manner and was considered to be not irritating to skin. Thus it cannot be classified for skin irritation.
Eye irritation
The ocular irritation potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -
An acute ocular irritation study was conducted for the given test chemical to determine the potential to induce eye irritation in 9 rabbits according to methods similar to OPPTS 870.2400 and OECD 405 guidelines. During the study, a single dose of 100 mg of the test chemical was instilled into one eye, the other eye was not treated and served as control. For 6 rabbits, the eyes were not rinsed after administration of the test chemical while a washing procedure was applied for 3 other animals. Ocular reactions were observed 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal. Mean scores calculated over 24, 48 and 72 hours for the 6 animals without rinsing were 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively. Washing procedure did not change the ocular reactions. Thus, under these experimental conditions, test chemical was considered as non-irritant when administered by ocular route to rabbits.
The above study was supported by the results of an eye irritation study conducted to determine the irritation potential of the test chemical on 3 Himalayan rabbits. In a study, 100 mg of test chemical was instilled into the conjunctival sac of the right eye of 3 Himalayan rabbits (4.5 to 5.5 months old; 2.4 to 2.5 kg body weight). One hour after the instillation the eyes were rinsed with 20 ml aqueous (0.9%) sodium chloride solution. The left eye served as control. One hour after the instillation the conjunctiva in all animals was reddened. This hyperaemic reaction was reversible after 24 hours. The cornea and iris were not affected. Systemic intolerance reactions were not observed. Since the observed effects were reversible within 24 hours, the chemical was considered as not irritating to the eyes.
Based on the available data, it can be concluded that the given test chemical cannot cause irritation to rodent’s eyes. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for eye irritation.
Justification for classification or non-classification
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, it was considered to be not irritating to skin and eye. Comparing the above annotations with the criteria of CLP regulation, it cannot be 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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