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EC number: 200-606-7 | CAS number: 65-30-5
- 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
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.
Eye Irritation
Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical
- GLP compliance:
- not specified
- Species:
- other: Human
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Department of Dermatology, University of Basel, Switzerland
- Age at study initiation: mean age – 38.6 years (range 23 – 65 years) - Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 5%
- Duration of treatment / exposure:
- 20 minutes
- Observation period:
- 20 minutes
- Number of animals:
- 14 patients (10 male and 4 female)
- Details on study design:
- TEST SITE
- Area of exposure: ventral forearm
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 20 minutes
SCORING SYSTEM:
- Method of calculation:The skin reactions were assessed 20min after application according to the following rating:
0 = No reaction
± = equivocal reaction
+ = erythema
++ = wheal
+++ = pseudopods
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 20 minutes
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 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.
- Interpretation of results:
- other: Not irritating
- Conclusions:
- 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.
- Executive summary:
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.
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 chemicalsdat
- 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
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: 2. not mentioned; 3. New Zealand White
- Details on test animals or tissues and environmental conditions:
- 2. sex: female
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 2. 0.08 gm funely ground chemical
3. no data available - Duration of treatment / exposure:
- 2. single exposure
3. no data available - Observation period (in vivo):
- 2. no data available
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. 3 female rabbits
3. no data available - Details on study design:
- 2. no data available
3. no data available - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 2. the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
3. not irritating to eyes. - Interpretation of results:
- other: not irritating
- Conclusions:
- Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.
- Executive summary:
Various studies have been reviewed to determine the skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ most commonly in rabbits. The results are mentioned below:
An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation. In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
This is supported by a similar study conducted to determine the ocular irritation potential of the test chemical in rabbits. The study was conducted as per Organisation for Economic Co-operation and Development (OECD), USEPA and Japanese Ministry of Agriculture, Forestry and Fisheries guidelines for Eye Irritation. New Zealand White rabbits (number, sex not specified) were used for the study. A single instillation of the test chemical was done in to the conjunctival sac of the rabbits (dose not mentioned) and observed for effects (duration of dosing, observation period not mentioned). The test chemical was considered to be not irritating to rabbit eyes.
Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.
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 skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ i.e humans, rabbits. The results are mentioned below:
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 a similar 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.
The above results are further supported by a dermal irritation study performed to evaluate the dermal irritation potential of the test chemical in rabbits. The study was conducted according to OECD 404 and EPA OPPTS 870.2500 Guidelines. 3 male New Zealand White rabbits were used for the study. A single topical application of 0.5 gram (applied as a paste with distilled water) of the test chemical was applied to the skin of rabbits for 4 hours. The rabbits were observed for signs of irritation. The test chemical failed to show any dermal reactions after 4 hours exposure. Hence, it can be considered to be not irritating to male New Zealand White Rabbit skin.
Based on the available results, the test chemical can be considered to be not irritating to skin. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
Eye irritation
Various studies have been reviewed to determine the skin irritation potential of the test chemical in living organisms. Mostly the studies have been performed on mammals’ most commonly in rabbits. The results are mentioned below:
An eye irritation study was performed to evaluate the ocular irritation potential of the test chemical in rabbits. The test chemical was performed according to OECD 405 and EPA OPPTS 870.2400 Guidelines. Single instillation of 0.08 g finely ground test chemical was done into the eyes of 3 female rabbits. The rabbits were then observed for signs of irritation. In rabbit eye irritation study, the test chemical was classified as minimally irritating to the eye under the classification scheme used in the study. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) however, this study would not trigger for eye irritation. Hence, the test chemical can be considered to be not irritating to eyes.
This is supported by a similar study conducted to determine the ocular irritation potential of the test chemical in rabbits. The study was conducted as per Organisation for Economic Co-operation and Development (OECD), USEPA and Japanese Ministry of Agriculture, Forestry and Fisheries guidelines for Eye Irritation. New Zealand White rabbits (number, sex not specified) were used for the study. A single instillation of the test chemical was done in to the conjunctival sac of the rabbits (dose not mentioned) and observed for effects (duration of dosing, observation period not mentioned). The test chemical was considered to be not irritating to rabbit eyes.
Based on the available results, and applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation.
Justification for classification or non-classification
Based on the available results, the test chemical can be considered to be not irritating to skin and eyes. Hence, the test chemical can be classified under the category "Not Classified" 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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