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Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 04 - September 12, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 22.03.1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Granulated textured wood (Granulate A2, J. Brandenburg, D-49424 Goldenstedt) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
Penodic analysis of the bedding material for contaminants based on EPA/USA IS conducted at least once a year by LUFA-ITL 4 (see Appendix 1: Limitation for contaminants in the bedding material).
During the 14-day observation penod the animals were kept in groups of 2 - 3 animals in MAKROLON cages (type Ill) at a room temperature of 22°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- the test substance was used as supplied for the 2000 mg/kg dose; corn oil was used as vehicle for the 200 mg/kg dose and for the 25 mg/kg dose
- Doses:
- step 1: 2000 mg/kg b.w.
step 2: 200 mg/kg b.w.
step 3: 25 mg/kg b.w. - No. of animals per sex per dose:
- three animals per step
- Control animals:
- no
- Details on study design:
- Observations were performed before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.
During the follow-up period (at least 2 weeks), changes of skrn and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behav1our pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to poss1ble tremor, convulsions, salivation, diarrhoea, lethargy, sleep and
coma. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals during the study. The time of death is recorded as precisely as possible. Individual body weights were recorded before administration of the substance and thereafter in weekly rntervals up to the end of the study, and at death. Changes in weight were calculated and recorded. At the end of the experiments (in the morning of test day 15), all survivrng animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. From animals which survived 24 hours or longer, a microscopic examination of all organs which showed evident lesions was performed.
Autopsy and macroscopic inspections of animals which died prematurely would have been carried out as soon as possible after exitus.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: based on interpretation scheme OECD 423, 22.03.1996
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 25 - < 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Step 1: male, 2000 mg/kg bw; number of animals: 3, number of deaths: 3
Step 2: male, 200 mg/kg bw; number of animals: 3, number of deaths: 1
Step 3: female, 200 mg/kg bw; number of animals:3, number of deaths: 2
Step 4: male, 25 mg/kg bw; number of animals:3, number of deaths: 0
Step 5: female, 25 mg/kg bw; number of animals:3, number of deaths: 1 - Clinical signs:
- at 2000 mg/kg b.w.: reduced motility, atax1a, reduced muscle tone, dyspnoea and mydriasis
at 200 mg/kg b.w.: reduced motility, ataxia, reduced muscle tone and dyspnoea.
at 25 mg/kg b.w.: No signs of systemic toxicity were noted - Body weight:
- All surviving an1mals gamed the expected body weight within the study period
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The oral LD50 value for PNCl2 in CD® rats was ranked within the LD50 range of > 50 - 200 mg/kg body weight.
- Executive summary:
The acute toxic class method according to OECD Guideline No. 423 was performed with the test item.
PNCI2 was administered orally by gavage to three male CD® rats at 2000 mg/kg body weight/ to six CD® rats (3 /sex) at 200 mg/kg body weight and in addition, to six CD® rats (3 / sex) at 25 mg/kg body weight. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic exammation was performed immediately after premature death or after terminal sacrifice (test day15).
2000 mg/kg b.w. resulted in the death of all male CD® rats within 60 minutes. The following symptoms were noted at 2000 mg/kg b.w.: reduced motility/ ataxia, reduced muscle tone, dyspnoea and mydriasis.
200 mgl/g b.w. resulted in the death of one male within 60 minutes and of two female CD® rats within 8 days. The following symptoms were noted at 200 mg/kg b.w.: reduced motility/ ataxia/ reduced muscle tone and dyspnoea.
25 mg/kg b.w. resulted in the death of one female CD® rat within 5 days. No signs of systemic toxicity were noted at 25 mg/kg b.w.
All surviving animals gamed the expected body weight within the study penod. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value for PNCI2 in CD® rats was ranked within the LD50 range of 25 - 200 mg/kg body weight. According to the interpretation scheme of OECD 423 adapted 22.03.1996 the LD50 ranges between > 50 - < 200 mg/kg body weight.
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