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EC number: 219-868-9 | CAS number: 2556-10-7
- 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
Acute oral toxicity (OECD TG 401): LD50 >5000 mg/kg bw
Acute dermal toxicity (OECD TG 402): LD50 >5000 mg/kg/ bw
Acute inhalation toxicity using route to route extrapolation from the oral route: > 13000 mg/m3
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:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-GLP study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals per dose
- Control animals:
- no
- Details on study design:
- - Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects. - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: none
- Gross pathology:
- none
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- Based on EU CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- The acute oral LD50 of Hyacinth body for rats was >5000 mg/kg bw. Based on the results of this study it is concluded that Hyacinth body is not acute orally toxic.
- Executive summary:
An acute oral toxicity study with Hyacinth body was performed according to a method similar to OECD TG 401, and was rated Klimisch 2 as it was performed comparable to guideline study with acceptable restrictions and it was pre-GLP. In this study, 10 rats were administered Hyacinth body at dose level 5000 mg/kg bw. None of the animals died. The acute oral LD50 for rats was therefore set at >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- pre-GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals per dose
- Control animals:
- no
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Slight redness: 3/10 Moderate redness: 5/10 Slight edema: 5/10 Moderate edema: 5/10
- Gross pathology:
- not specified
- Other findings:
- No further symptoms were noted.
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- Based on EU CLP Criteria (EC 1272/2008 and its updates)
- Conclusions:
- An acute dermal toxicity study was performed with Hyacinth body according to a method similar to OECD TG 402. The dermal LD50 was therefore set at >5000 mg/kg/ bw. Based on the results of this study it is concluded that Hyacinth body is not acute dermally toxic.
- Executive summary:
An acute dermal toxicity study was performed with Hyacinth body according to a method similar to OECD TG 402 and was rated Klimisch 2 as it was performed comparable to guideline study with acceptable restrictions and pre-GLP. In this study, 10 rabbits were dermally exposed to Hyacinth body at dose level 5000 mg/kg bw. There were no mortalities in this study. The clinical sign noted was a skin irritation demonstrated in slight to moderate redness (in eight animals in total) and slight to moderate edema (in all animals).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute oral toxicity
An acute oral toxicity study with Hyacinth body was performed according to a method similar to OECD TG 401, and was rated Klimisch 2 as it was performed comparable to guideline study with acceptable restrictions and it was pre-GLP. In this study, 10 rats were administered Hyacinth body at dose level 5000 mg/kg bw. None of the animals died. The acute oral LD50 for rats was therefore set at >5000 mg/kg bw.
A number of other studies are available, they are considered supporting to the results described in above mentioned key study. In a study by PFW, (1976a) similar to OECD 401, an LD50 > 5 g/kg in rabbits was reported. Furthermore, Givaudan, (1971p); OECD 401 reported that 5 g/kg was lethal in 1/10 rats on day 13, but there were no signs of toxicity. Necropsy revealed a mottled liver, dark lungs, small intestine and red stomach in one animal. A fourth study by Quest, (1977o) reported an LD50 > 10 ml/kg.
Acute dermal toxicity
An acute dermal toxicity study was performed with Hyacinth body according to a method similar to OECD TG 402 and was rated Klimisch 2 as it was performed comparable to guideline study with acceptable restrictions and pre-GLP. In this study, 10 rabbits were dermally exposed to Hyacinth body at dose level 5000 mg/kg bw. There were no mortalities in this study. The clinical sign noted was a skin irritation demonstrated in slight to moderate redness (in eight animals in total) and slight to moderate edema (in all animals).
Acute inhalation toxicity
Acute inhalation is predicted based on the acute oral toxicity in accordance with the ECHA CLP guidance document (2017, Section 3.1.3.3.5, pg 250: 1 mg/kg bw = 0.0052 mg/L (5.2 mg/m3). The acute inhalation is predicted to be > 13000 mg/m3 (using 100% inhalation and 50% oral absorption and an LD50 oral of > 5000 mg/kg bw). The calculated saturated vapour concentration is 247 mg/m3 (at 24 ºC and 1 atmosphere), using the following formula: MW * VP (in Pa) * 1000 (g to mg) / [(8.3 (gas constant) * 293 (°K)] = 194.28 * 3.1 * 1000/ (8.3 * 293). This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation toxicity is anticipated.
Justification for classification or non-classification
Based on the available data it is concluded that Hyacinth body does not need to be classified for acute oral, dermal and inhalation toxicity in accordance with EU CLP (EC No. 1272/2008 and its amendments)
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