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EC number: 229-114-0 | CAS number: 6413-10-1
- 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
ORAL
LD50 > 5.0 g/kg, rat, Moreno (1980 & 1978)
DERMAL
LD50 > 5.0 g/kg, rabbit, Moreno (1980 & 1978)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- No guideline, or experimental methodology, stipulated in report summary.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further information on test animals and environmental conditions is reported.
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 10 animals were used in the study.
- Control animals:
- not specified
- Details on study design:
- no data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- not specified
- Mortality:
- None of the 10 animals tested died during the study.
- Clinical signs:
- other: Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea.
- Gross pathology:
- Nine of the survivors appeared normal at necropsy. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.
- Executive summary:
The acute oral toxicity of the test material was investigated with 10 rats in a limit test. The animals were orally administered test material at 5.0 g/kg.
None of the 10 animals tested died during the study. Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea. At necropsy, nine of the animals appeared normal. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth.
The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.
The summary report contains extremely limited detail on experimental conditions.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- No guideline, or experimental methodology, stipulated in the report summary.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further information on test animals and environmental conditions is reported.
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 10 animals were used in the study.
- Control animals:
- not specified
- Details on study design:
- no data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- not specified
- Mortality:
- None of the 10 animals tested died during the study.
- Clinical signs:
- other: There were no principal toxic signs.
- Gross pathology:
- All of the survivors appeared normal at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.
- Executive summary:
The acute oral toxicity of the test material was investigated with 10 rats in a limit test. The animals were orally administered test material at 5.0 g/kg. None of the 10 animals tested died during the study. There were no principal toxic signs and all of the survivors appeared normal at necropsy. The acute oral LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.
The summary report contains extremely limited detail on experimental conditions.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Two study summaries are available. However, neither provide detail on experimental conditions; it is therefore not possible to assess the reliability of the presented results. Both studies were assigned a reliability score of 4 according to the criteria of Klimisch. Since both studies provided that same result, the overall reliability is improved when the studies are considered in a weight of evidence approach. Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- No guideline or experimental methodology stipulated in the report summary.
- GLP compliance:
- yes
- Remarks:
- study pre-dates GLP
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further information on test animals and environmental conditions is reported.
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- no data
- Duration of exposure:
- no data
- Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 10 animals were used in the study.
- Control animals:
- not specified
- Details on study design:
- no data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- not specified
- Mortality:
- None of the 10 animals tested died during the study.
- Clinical signs:
- other: Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip.
- Gross pathology:
- Eight survivors appeared normal at necropsy. Two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.
- Other findings:
- Skin irritation was observed on day 1.
Slight redness was observed in eight animals and moderate redness was observed in one animal; the other treated animal was observed to have no redness.
Slight edema was noted on 4 animals, moderate edema on 2 animals and no edema on the remaining 4 animals. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.
- Executive summary:
The acute dermal toxicity of the test material was investigated with 10 rabbits; each was dermally administered 5.0 g/kg test material, in a limit test. None of the animals tested died during the study. Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip. Slight to moderate redness and edema was noted in some animals during the observations for skin irritatation on day 1. At gross necropsy eight survivors appeared normal, two had bright orange lungs, one had a mottled kidney, and one had a pale kidney.
The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- No guideline or experimental methodology stipulated in the report summary.
- GLP compliance:
- yes
- Remarks:
- study pre-dates GLP
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further information on test animals and environmental conditions is reported.
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- no data
- Duration of exposure:
- no data
- Doses:
- 5.0 g/kg
- No. of animals per sex per dose:
- 10 animals were used in the study.
- Control animals:
- not specified
- Details on study design:
- no data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- not specified
- Mortality:
- None of the 10 animals tested died during the study.
- Clinical signs:
- other: There were no principal toxic signs.
- Gross pathology:
- At gross pathology one survivor had a soiled anogenital area and caecum.
- Other findings:
- Skin irritation on day 1 was observed to be absent to slight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.
- Executive summary:
The acute dermal toxicity of the test material was investigated with 10 rabbits; each was dermally administered 5.0 g/kg test material, in a limit test. None of the animals died during the study. There were no principal toxic signs and nine of the survivors appeared normal at gross necropsy. At gross necropsy one survivor had a soiled anogenital area and caecum. Skin irritation on day 1 was observed to be absent to slight.
The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Two study summaries are available. However, neither provide detail on experimental conditions; it is therefore not possible to assess the reliability of the presented results. Both studies were assigned a reliability score of 4 according to the criteria of Klimisch. Since both studies provided that same result, the overall reliability is improved when the studies are considered in a weight of evidence approach. Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.
Additional information
Oral
Summaries are available on two acute oral toxicity studies which were conducted with rats. Each was performed as a limit test whereby 10 rats were orally administered with 5.0 g/kg of test material.
In the first study (Moreno, 1980), none of the 10 animals tested died during the study. There were no principal toxic signs and all of the survivors appeared normal at necropsy. The acute oral LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.
In the second study (Moreno, 1978), none of the 10 animals tested died during the study. Toxic signs at 5.0 g/kg included lethargy, ataxia, ptosis, diarrhea, piloerection, chromorhinorrhea and chromodacryorrhea. At necropsy, nine of the animals appeared normal. One animal had dark areas in the lungs and a yellow exudate in the nose/mouth. Again, the acute oral LD50 of the test material was reported to be in excess of 5.0 g/kg.
Both summary reports contain extremely limited detail on experimental conditions.
Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.
The available data are considered to be complete and the result determined, oral LD50 ≥ 5000 mg/kg, was taken forward for risk assessment.
Dermal
Summaries are available on two acute dermal toxicity studies which were conducted with rabbits. Each was performed as a limit test whereby 10 rabbits each received dermal applications of test material at a concentration of 5.0 g/kg.
In the first study (Moreno, 1980), none of the animals tested died during the study. There were no principal toxic signs and nine of the survivors appeared normal at gross necropsy. At gross necropsy one survivor had a soiled anogenital area and caecum. Skin irritation on day 1 was observed to be absent to slight. The acute dermal LD50 of the test material was therefore reported to be in excess of 5.0 g/kg.
In the second study (Moreno, 1978), none of the animals tested died during the study. Toxic signs included lethargy, diarrhea, ptosis, yellow exudate at nose with white nasal discharge, mucus in stool, bloated abdomen and sore under lower lip. Slight to moderate redness and edema was noted in some animals during the observations for skin irritation on day 1. At gross necropsy eight survivors appeared normal, two had bright orange lungs, one had a mottled kidney, and one had a pale kidney. Again, the acute dermal LD50 of the test material was reported to be in excess of 5.0 g/kg.
Both summary reports contain extremely limited detail on experimental conditions.
Together, the studies are deemed adequate for assessment as an accurate reflection of the substance.
The available data are considered to be complete and the result determined, dermal LD50 ≥ 5000 mg/kg, was taken forward for risk assessment.
Justification for selection of acute toxicity – oral endpoint
No single study is selected as the key study. The two available studies were considered together in a weight of evidence approach.
Justification for selection of acute toxicity – dermal endpoint
No single study is selected as the key study. The two available studies were considered together in a weight of evidence approach.
Justification for classification or non-classification
Oral
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the studies.
Dermal
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the studies.
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