Registration Dossier
Registration Dossier
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EC number: 305-644-9 | CAS number: 94891-43-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-02-01 to 1979 02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Internal Guideline Hoechst AG
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- EC Number:
- 305-644-9
- EC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Cas Number:
- 94891-43-7
- Molecular formula:
- C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
- IUPAC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hoe WISKf(SPF71)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 222 to 240 g (average 233 g, s = +- 6.48g, n=10)
- Fasting period before study: 16 hours prior administration and 2 hours after administration
- Housing: plastic cage; wood shavings; in groups
- Diet: Altromin 1324 rat standard diet ad libitum
- Water: tap ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: demineralized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 % test item in a water solution (25g/ad 100 mL) - Doses:
- 5000 mg/kg body weight
(Application volumen 4.4 to 4.8 mL) - No. of animals per sex per dose:
- 10 females
- Control animals:
- no
- Details on study design:
- Observation period: 14 days after test substance administration
- Frequency of observations and weighing: weakly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Exact determination of LD50 not possible (Limit test)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 4 animals died between 330 minutes and 24 hours after application
- Clinical signs:
- symptoms of the 4 died animals:
crouched position, raised hair, straitened lid slit, passivity, abdominal position, vestibular disorder, straddled legs, convulsions, tonic-clonic seizures, blood colored tear fluid, intermittent shallow breathing
surviving animals:
same clinical signs, but in milder form and reversible after 48 after administration - Body weight:
- normal body weight gain during the observation period
- Gross pathology:
- Stomachs, small intestines, and fat tissue of the abdomen was blue colored (330 minutes p.a.).
Small intestines were green colored, black-blue colored pulpy stomach contents, and green colored fat tissue of the abdomen (1st / 2nd d).
Surviving animals: Macroscopically; greenish intestinal tract and an intensive dark green colored kidney.
A clearly green coloration of the cortex of the kidney was observed when the kidney was excised. - Other findings:
- Urinary clear and colourless
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 of approximate 5000 mg/kg bw was determined. The substance is not classifiable according to CLP criteria.
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