Registration Dossier
Registration Dossier
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EC number: 255-965-2 | CAS number: 42844-93-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- well performed study according to GLP and OECD 423
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (directive 96/54/EEC)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
- EC Number:
- 255-965-2
- EC Name:
- [1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel
- Cas Number:
- 42844-93-9
- Molecular formula:
- C29H18N4NiO3
- IUPAC Name:
- Nickel, [1,3-dihydro-5,6-bis[[[2-(hydroxy-kO)-1-naphthalenyl]methylene]amino-kN]-2H-benzimidazol-2-onato(2-)]-, (SP-4-2)-
- Test material form:
- solid: nanoform
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Breeding Division, Füllinsdorf, Switzerland
- Age at study initiation: 9 1/2 weeks
- Weight at study initiation: 213.1 - 218.3 g (males); 163.3 - 171.7 g (females)
- Fasting period before study: 17 h
- Housing: Macrolon cages (type 4) in groups of three
- Diet: peletted standard Kliba 3433 rat maintenance diet (batch no. 04/00, Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: community tap water; ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 36 - 57 %
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes (per hr): 10 - 15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL (w/v); mixture was prepared shortly before each dosing
- Application volume: 10 mL/kg bodyweight - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, 3 and 5 hours after administration on day 1; twice daily during days 2 - 15
- Frequency of weighing: on test days 1, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animals died within the 14 day observation period
- Mortality:
- no deaths occurred during the study
- Clinical signs:
- other: moderate to marked orange coloration of faeces was observed for the females from day 2 to 4.
- Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Single application of the limit dose of 2000 mg test substance per kg bodyweight did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
- Executive summary:
Male and female rats were treated orally to test acute oral toxicity according to the acute class method (OECD TG 423, limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw to two groups of 3 animals each. Orange discoloured faeces were observed in the group of female animals from day 2 to 4. The body weight development of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
No animal died within the observation period, resulting in a LD50 > 2000 mg/kg bw.
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